Dry Eye Management amp Treatment

PENNY A ASBELL MD FACS MBA

CONTRIBUTOR SHIR LEVANON

HAMILTON EYE INSTITUTE

UNIVERSITY OF TENNESSEE HEALTH SCIENCE CENTER

2018

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Financial Disclosure

Alcon Novarits

B amp L

CLAO

Kao

MC2

Regeneron

Santen

Senju

Shire

Web MD

Research to Prevent Blindness

Martin and Toni Sosnoff Foundation

NEI

I have the following financial interests or relationships to disclose

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DED Overview

bull DREAM Study Results

bull New Dry Eye Treatment Optionso Lids- MGDoAnti- inflammatoriesoTear composition

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Patient Population and TreatmentBroad spectrum of symptomatic patients with moderate or severe DED

REAL WORLD PATIENTS

Can continue current treatment

Symptoms for at least 6 months

Signs at screening visit and eligibility confirmation visit

bull Supplements ndash 5 softgels per day

bull Active ndash 3 gm ω3 per day

bull 2 gm EPA + 1 gm DHA

bull Fish oil concentrate (triglyceride)

bull Placebo - 5 gm olive oil per day

bull Identical in size color aroma

bull Fish essence added to placebo

bull Lemon essence to both to mask fish odor

bull 15mg Vitamin E as an anti-oxidant

The Dry Eye Assessment and Management Study

2018

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Study Visits and Treatment Assignment

Screening

Eligibility Confirmation

Randomization

Placebo

3 Months

6 Months

12 Months

Active ω3

3 Months

6 Months

12 Months

23 13

535 Subjects

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Mean Scores of Signs Over TimeMean Change in OSDI Score Over Time

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DREAM Results

When patients who had moderate to severe dry eye disease despite use of other treatments were randomly assigned to ω3 or placebo supplements mean values for symptoms and signs improved

However we found no evidence of a beneficial effect of ω3 supplements on the symptoms and signs DED relative to placebo supplements

A therapeutic effect of 1 teaspoon of refined olive oil daily is not plausible1

1 Abell Penny A and Maureen G Maguire ldquonminus3 Fatty Acid Supplementation and Dry Eye Diseaserdquo New England Journal of Medicine vol 379 no 7 2018 pp 690ndash691

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Strengths of DREAM

bullGeneralizability ω3 added to existing treatments in patients who still had symptoms and signs despite Rx ndash REAL WORLD PATIENTSbullComparability of Groups Randomization ldquoworkedrdquobullCompliance

bull Drugs delivered to home even when missed visit

bull High rates of compliance by blood testbull Missed visit rate lt 10

bull Treatment bull Highest dose (3000 mg) of ω3 in any DED RCTbull Triglyceride ω3 form more bioavailable than ethyl esterbull Content verified by an outside laboratorybull Softgels active identical to placebobull 12 months ndash reduce seasonality effects

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New Treatment Options

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Meibomian Gland Dysfunctionbull A leading cause of Dry Eye1

bull Clinical signs of MGD2o Aberrant medium production andor composition due to Obstruction of meibomian gland (a) Gland dropout (b) Change in gland secretion (c)

bull Patients complaining of repeated lsquostyesrsquo

bull Characterized by tear film instability and rapid TFBUT1Nichols KK Foulks GN Bron AJ et al The International Workshop on Meibomian Gland Dysfunction Executive Summary

Investigative Ophthalmology amp Visual Science 201152(4)1922-19292American Academy of Ophthalmology Retina Panel Preferred Practice PatternregGuidelines Blepharitis San Francisco

CA American Academy of Ophthalmology 2008 Available at httpwwwaaoorgppp

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Meibomian Gland Dysfunction - Treatments

Heating amp Pressure Devices

bull Lipiflow

bull Intense Pulsed Light (IPL)

bull iLux

bull Blephex

bull NuLids

bull Blephasteam

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LipiFlowreg TearScience

bull FDA clearancebull Thermal pulsation Devicebull 12 minute treatmentbull Delivers heat to the inner eyelid and massage to the outside unblock the flow of lipids from the meibomian glandsbull Preliminary evidence At 3 months-1 year follow-up improved symptoms and signs (secretions TBUT)1-5

1Lane SS et al Cornea 2012 Apr31(4)396-4042Greiner JV Curr Eye Res 2012 Apr37(4)272-83Greiner JV Clin Experiment Ophthalmol 2013 Aug41(6)524-304Finis D et al Ocul Surf 2014 Apr12(2)146-545Finis D et al Cornea 2014 Dec33(12)1265-70

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Intense Pulsed Light (IPL) Lumenis or E-eyeMain effect lower eyelidsHypothesized mechanism of action1) Treat abnormal blood vessels near eyelid to close them off decrease inflammation2) Thermal treatment softens the glands and allows to discharge secretions more readilySome evidence of therapeutic potential but further studies needed1-2

1Toyos R et al Photomed Laser Surg 2015 January 1 33(1) 41ndash462Craig JP et al Invest Ophthalmol Vis Sci 2015 Feb 1256(3)1965-70 doi 101167iovs14-15764

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iLuxreg Tear Film Innovationsbull Main effect unblocks Meibomian glandsbull Heat amp pressure therapybull 8-12 min treatmentbull Handheld Devicebull Glands can be viewed via magnifier

bull No clinically significant differences between iLux and LipiFlow with respect to indication for use and device performance1

1ldquo510(K) SUMMARY ndash K172645rdquo US Food amp Drug Administration Dec 2017 wwwaccessdatafdagovcdrh_docspdf17K172645pdf

2018

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BlephExreg Rysurgbull FDA clearance bull Main effect lid margin debridement bull 6-8 minute treatmentbull In-officebull Lasts three to six months before requiring a

retreatmentbull Evidence of improvement for contact lens

wearers through significant reduction in bacterial load on patientsrsquo eyelids1

1Siddireddy JS Tan-Showyin J Vijay AK Willcox M A Comfortable Eye Needs Fats Presented at the University of New South Wales Sydney Australia 2015

Rysurgcom

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Blephasteamreg Laboratoires Theacuteabull Main effect warming goggles that promote fluidization Meibomian glands secretions through heat and pressure bull ESPOIR Study evidence of significant improvement in symptoms using the visual analogous scale (VAS)1

bull Expensive devicebull Need further studies with larger samples sizes

to determine efficacy2

1 Doan S Chiambaretta F Gabison EE Cochereau I Baudoin C Efficacy of heating wet chamber warming goggles (Blephasteamreg) in adult posterior blepharitis Invest Opthalmol Vis Sci 201152 E-Abstract 38332Benitez Del Castillo JM Kaercher T Mansour K Wylegala E Dua H Evaluation of the efficacy safety and acceptability of an eyelid warming device for the treatment of meibomian gland dysfunction Clin Ophthalmol 201482019ndash2027

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NuLidstrade NuSight

bull Main effect lid scrub that stimulates Meibomian glands by removing biofilm and scurf that block the opening of the glands

bull Doctor-prescribed In-home treatmentbull 60 second daily treatmentbull A multi-center clinical study showed

evidence of 50 decrease in dry eye symptoms 65 improvement in TBUT and 81 improvement in Meibomian Gland liquid secretions1

1Schanzlin Olkowski Coble Gross NuLids II Study April 2018

2018

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TearCare System Sight Sciences

bull First wearable therapeutic eyelid therapy devicebull In-office treatmentbull 12 minute thermal eyelid treatment followed by expression forceps to

manually evacuate residual obstructionsbull Evidence from pilot study suggested improved TBUT corneal and

conjunctival staining scored and dry eye symptoms based on OSDI SPEED and SANDE1

bull Further clinical evidence underway

Badawi David A novel system TearCarereg for the treatment of the signs and symptoms of dry eye disease Clinical Ophthalmology (Auckland NZ) 12 (2018) 683

2018

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Anti-Inflammatory Pharmaceuticals

Cyclosporine

Main effectbull Anti-inflammatory therapy

bull Inhibits T-cell maturation

bull Decreases pro-inflammatory cytokines

bull Upregulates anti-inflammatory cytokines20

18 copy

48th

Europ

ean C

ontac

t Len

s Soc

iety O

f Oph

thalm

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ts A

ll righ

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serve

d - A

ny re

prod

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art is

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Cyclosporine A cationic emulsion 01 (Ikervisreg Santen)

bull Approved in Europe in 2015bull Main effect prolonged precorneal residence time and improved

bioavailabilityo Indicated for patients with severe DED that has not improved

using tear substitutesbull Clinical evidence of reduced HLA-DR expression at 6 mo measured

through impression cytology overall greater benefits for patients with Sjoumlgrenrsquos Syndrome1

1Leonardi A Messmer EM Labetoulle M et al Efficacy and safety of 01 ciclosporin A cationic emulsion in dry eye disease a pooled analysis of two double-masked randomised vehicle-controlled phase III clinical studies Br J Ophthalmol 2018

2018

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Cyclosporine 009 (OTX-101 CequaTM Sun Pharma)

bull FDA Approval Aug 2018

bull Highest FDA-approved concentration of cyclosporine A1

bull Main effect Increase tear production

bull Calcineurin inhibitor

bull Nanomicellar formulation eases entry into corneal and conjunctival cells

bull Two multicenter studies report a statistically significant increase (ge 10 mm) in Schirmer wetting at 3 mo in patients receiving CequaTM vs vehicle1

Cyclosporine - New Preparations

Biospacecom

1epgonlineorg ldquoFDA Approves CEQUA to Treat Dry Eye Syndrome- Sun Pharma + Sun Ophthalmicsrdquo Epgonlineorg Aug 2018 wwwepgonlineorgusnewsfda-approves-cequa-to-treat-dry-eye-syndrome---sun-pharma---sun--ophthalmics-html

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Cyclosporine 005 and 01 (CyclASol Novaliq)

bull Semifluorinated alkanes formulation better dissolves Cyclosporine Abull Greater penetration than FDA-approved 005 Cyclosporine A

(Restasis)bull Evidence of decreased corneal and conjunctival staining after 14

days2

bull It remains unknown whether greater concentration leads to better results phase 3 studies are underway3

2Novaliq CyclASolreg ndash Cyclosporine in SFA for Ophthalmological Application to Treat Dry Eye Syndrome 20153 Lallemand F Shmitt M Bourges JL et al Cyclosporine A delivery to the eye a comprehensive review of academic and industrial efforts Eur J Pharm Biopharm 201711714-28

2018

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Cyclosporin with chondroiton sulphate

Klarity- C

Imprimis- compounded

chondroitin sulfate

2018

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SkQ1 bull Main effects synthesized small molecule targeted to reduce oxidative stress in cellmitochondria

o Regenerates itself o SkQ1 ophthalmic solution is indicated for pathologies of the eye associated with

oxidative stress such as dry eye 1

o Approved in Russia (2011) and marketed as Visomitinbull Clinical evidence suggest statistically significant 2

o Decrease in corneal stainingo Improvements in lid margin rednesso Improvements in symptoms measuredo through Ora CalibraTM scales

1Wakamatsu TH Dogru M Tsubota K Tearful relations oxidative stress inflammation and eye diseases Arq Bras Oftalmol 200871(6 Suppl)72ndash92Petrov Anton et al SkQ1 ophthalmic solution for dry eye treatment results of a phase 2 safety and efficacy clinical study in the environment and during challenge in the controlled adverse environment model Advances in therapy 331 (2016) 96-115

2018

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Steroids- new formulation bullKPI-121- Kala Pharmaceuticals

bullMucous ndash penetrating particle ( MPP) ndashbullnano particles

bullLoteprednol -025

bull Better penetration low dose steroid

bullEpisodic flare ups of DED

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ADX-102 (Reproxalap Aldeyra Therapeutics)bull Small molecule topical agentbull Traps aldehydes that usually activate inflammatory factorsbull Positive clinical evidence of improvement in signs and

symptoms of dry eye1

Thymosin beta 4 (Tβ4 ) bull 43-amino acid G-actin binding proteinbull Downregulates transcription of inflammatory mediators and promotes corneal

epithelial cell migrationbull Phase 3 clinical trial with Tβ4 (RGN-259 RegeneRx) showed improvement in signs

and symptoms of dry eye through corneal staining tear production and expression of inflammatory factors2

1Aldehyde trap drug rapidly improves signs symptoms of dry eye disease American Academy of Ophthalmology (2017) httpswwwaaoorgheadlinealdehyde-trap-drug-rapidly-improves-signs-symptoms2Kim Chae Eun et al RGN-259 (thymosin β4) improves clinically important dry eye efficacies in comparison with prescription drugs in a dry eye model Scientific reports 81 (2018) 10500

Aldeyracom

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Tear Enhancements

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bull Currently approved in Japan and South Korea1

bull Main Effect Increase tear fluid and mucin secretion on the ocular surface through interaction with P2Y2 receptors in the conjunctiva

bull Evidence from clinical trials suggest diquafosol improves corneal staining more effectively than a comparable sodium hyaluronate solution2

Diquafosol Tetrasodium(3 Ophthalmic Solution)

1Koh Shizuka Clinical utility of 3 diquafosol ophthalmic solution in the treatment of dry eyes Clinical Ophthalmology (Auckland NZ) 9 (2015) 8652Takamura Etsuko et al A randomised double-masked comparison study of diquafosol versus sodium hyaluronate ophthalmic solutions in dry eye patients British Journal of Ophthalmology 9610 (2012) 1310-1315

Pubmedcom

Santencom

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Rebapimide

(2 Ophthalmic Solution)

bull Currently approved in Japanbull Main Effect stimulates mucin secretagogue activity in

cornea and conjunctivabull Clinical evidence suggests

o Statistically significant Improvement in corneal and conjunctival staining as well as in quality of life as well as in tear break-up time12

o Potential role in suppressing the expression of inflammatory proteins (Polyl)3

1 Kinoshita Shigeru et al Rebamipide (OPC-12759) in the treatment of dry eye a randomized double-masked multicenter placebo-controlled phase II study Ophthalmology11912 (2012) 2471-24782 Kashima Tomoyuki et al Rebamipide ophthalmic suspension for the treatment of dry eye syndrome a critical appraisal Clinical ophthalmology (Auckland NZ) 8 (2014) 10033Ueta Mayumi et al Rebamipide suppresses PolyI C-stimulated cytokine production in human conjunctival epithelial cells Journal of Ocular Pharmacology and Therapeutics 297 (2013) 688-693

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TrueTearreg Allerganbull FDA Clearancebull Main effect intranasal applicator sends

electrical currents to nerves that stimulate tear production

bull Evidence of improved Schirmer scores decreased symptoms and corneal and conjunctival staining at 6 mo Ocular comfort lasted for 3 hours following neurostimulationo Secondary effect intranasal application

promotes goblet cell mucin secretion which stabilizes the tear film1

Truetearcom

1Gumus K Schuetzle KL Pflugfelder SC Randomized controlled crossover trial comparing the impact of sham or intranasal tear neurostimulation on 654 GD Novack et al The Ocular Surface xxx (2017) 635e655 conjunctival goblet cell degranulation Am J Ophthalmol 2017177159e68

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Pharmaceutical to stimulate nerves

bullNasal Spray OC-01

bullOyster Point Pharma

bullStimulate natural tears

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Amniotic cytokine extract(Ocular Science)bullACE is a novel drop marketed as Genesis bullContains various cytokines growth factor

and anti-inflammatory moleculesbull Effective in a small pilot study

Amniotic Cytokine Extract Promising in Patients with Dry Ey Disease MDLinx

httpswwwmdlinxcomophthalmologyarticle1280 1113088 Accessed Jan 27 2018

Amniotic Cytokine Extract Promising in Patients with Dry Ey Disease MDLinx

httpswwwmdlinxcomophthalmologyarticle1280 1113088 Accessed Jan 27 2

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Recombinant human nerve growth factor (OxervateTM eye drops Dompeacute)

bull FDA Approval Aug 2018o First approved drug for Neurotropic keratitis (NK) ndashdegenerative disease with loss of corneal sensation o Topical eye drop o Clinical evidence of complete corneal healing in 70 of patients treated with Oxervate after 8 weeks1

1Bonini S et al Phase II Randomized Double-Masked Vehicle-Controlled Trial of Recombinant Human Nerve Growth Factor for Neurotrophic Keratitis Ophthalmology 125 1332ndash1343 (2018)

2018

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Perfluorohexyloctane (NovaTears Novaliq)

bull Main effect prevent evaporative DED by increasing tear film and lipid layer thickness

bull Approved in Europe Australia and New Zealandbull Clinical evidence of increased tear production and tear film

stability as well as significant decrease in OSDI scores and in corneal staining1

1Steven P et al Semifluorinated Alkane Eye Drops for Treatment of Dry Eye Disease ndash A Prospective Multicenter Noninterventional Study J Ocul Pharmacol Ther 2015 Oct 1 31(8) 498-503

Corneal Epithelium Healing

2018

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2018

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CrossThiolated Carboxymethyl Hyaluronic Acid Liquid-Gel

(Ocular Bandage Gel EyeGate Pharma)

bull Main effects accelerate corneal healing and reduce corneal stainingo Indicated for defects due to photorefcrative keratectomy (PRK)o Indicated for Punctate epitheliopathies (PE) associated with

dry eyebull Treatment in development July 2018 approval to conduct two

pilot studies using OBG for PE and PRKbull A first-in-human pilot study (n=39) showed accelerated corneal

reepithelialization through slit lamp examination at day 1 after PRK Further studies needed1

1Durrie Daniel S et al Ability of a new crosslinked polymer ocular bandage gel to accelerate reepithelialization after photorefractive keratectomy Journal of Cataract amp Refractive Surgery 443 (2018) 369-375

2018

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Biologic MoleculesDry Eye Assessment

bull Proteoglycan-4 (Lubricin)oRecently discovered on the ocular surface in the meibomian glands2

oFunctions to prevent friction at the cornea-lid interface and has anti-inflammatory propertiesoCommercial lubricin-based lubricants remain scarceoEvidence from clinical studies with recombinant human lubricin suggest

significant improvement in signs and symptoms of DED through TBUT corneal staining and eyelid and conjunctival redness3

1De Paiva CS Chotikavanich S Pangelinan SB Pitcher 3rd JD Fang B Zheng X et al IL-17 disrupts corneal barrier following desiccating stress Mucosal Immunol 20092(3)243ndash2532Iqbal SM Leonard C Regmi SC De Rantere D Tailor P Ren G et al LubricinProteoglycan 4 binds to and regulates the activity of Toll-Like Receptors In Vitro Sci Rep20166189103Lambiase A Sullivan BD Schmidt TA Sullivan DA Jay GD Truitt ER et al A Two-Week Randomized Double-masked Study to Evaluate Safety and Efficacy of Lubricin

(150 mugmL) Eye Drops Versus Sodium Hyaluronate (HA) 018 Eye Drops (Vismed(R)) in Patients with Moderate Dry Eye Disease Ocul Surf 20171577ndash87

2018

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Why Ocular Biomarkers

Surrogate Endpoints- None accepted by the FDA or Europe to date Validation needed- clear clinical relevance

Enrichment of Study Population Still regulatory hurdles

Support mechanism of action of treatment Topical ciclosporin in Europe for Dry eyes (Europe2015 Ikervis)1

SEGMENT THE DRY EYE POPULATION- TREAT MORE SPECIFICALLY-PERSONALIZE TREATMENT

1 Ikervis SmPC June 2015 available at httpswwwmedicinesorgukemcmedicine30584

2018

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Financial Disclosure

Alcon Novarits

B amp L

CLAO

Kao

MC2

Regeneron

Santen

Senju

Shire

Web MD

Research to Prevent Blindness

Martin and Toni Sosnoff Foundation

NEI

I have the following financial interests or relationships to disclose

2018

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DED Overview

bull DREAM Study Results

bull New Dry Eye Treatment Optionso Lids- MGDoAnti- inflammatoriesoTear composition

2018

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Patient Population and TreatmentBroad spectrum of symptomatic patients with moderate or severe DED

REAL WORLD PATIENTS

Can continue current treatment

Symptoms for at least 6 months

Signs at screening visit and eligibility confirmation visit

bull Supplements ndash 5 softgels per day

bull Active ndash 3 gm ω3 per day

bull 2 gm EPA + 1 gm DHA

bull Fish oil concentrate (triglyceride)

bull Placebo - 5 gm olive oil per day

bull Identical in size color aroma

bull Fish essence added to placebo

bull Lemon essence to both to mask fish odor

bull 15mg Vitamin E as an anti-oxidant

The Dry Eye Assessment and Management Study

2018

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Study Visits and Treatment Assignment

Screening

Eligibility Confirmation

Randomization

Placebo

3 Months

6 Months

12 Months

Active ω3

3 Months

6 Months

12 Months

23 13

535 Subjects

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Mean Scores of Signs Over TimeMean Change in OSDI Score Over Time

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DREAM Results

When patients who had moderate to severe dry eye disease despite use of other treatments were randomly assigned to ω3 or placebo supplements mean values for symptoms and signs improved

However we found no evidence of a beneficial effect of ω3 supplements on the symptoms and signs DED relative to placebo supplements

A therapeutic effect of 1 teaspoon of refined olive oil daily is not plausible1

1 Abell Penny A and Maureen G Maguire ldquonminus3 Fatty Acid Supplementation and Dry Eye Diseaserdquo New England Journal of Medicine vol 379 no 7 2018 pp 690ndash691

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Strengths of DREAM

bullGeneralizability ω3 added to existing treatments in patients who still had symptoms and signs despite Rx ndash REAL WORLD PATIENTSbullComparability of Groups Randomization ldquoworkedrdquobullCompliance

bull Drugs delivered to home even when missed visit

bull High rates of compliance by blood testbull Missed visit rate lt 10

bull Treatment bull Highest dose (3000 mg) of ω3 in any DED RCTbull Triglyceride ω3 form more bioavailable than ethyl esterbull Content verified by an outside laboratorybull Softgels active identical to placebobull 12 months ndash reduce seasonality effects

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New Treatment Options

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Meibomian Gland Dysfunctionbull A leading cause of Dry Eye1

bull Clinical signs of MGD2o Aberrant medium production andor composition due to Obstruction of meibomian gland (a) Gland dropout (b) Change in gland secretion (c)

bull Patients complaining of repeated lsquostyesrsquo

bull Characterized by tear film instability and rapid TFBUT1Nichols KK Foulks GN Bron AJ et al The International Workshop on Meibomian Gland Dysfunction Executive Summary

Investigative Ophthalmology amp Visual Science 201152(4)1922-19292American Academy of Ophthalmology Retina Panel Preferred Practice PatternregGuidelines Blepharitis San Francisco

CA American Academy of Ophthalmology 2008 Available at httpwwwaaoorgppp

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Meibomian Gland Dysfunction - Treatments

Heating amp Pressure Devices

bull Lipiflow

bull Intense Pulsed Light (IPL)

bull iLux

bull Blephex

bull NuLids

bull Blephasteam

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LipiFlowreg TearScience

bull FDA clearancebull Thermal pulsation Devicebull 12 minute treatmentbull Delivers heat to the inner eyelid and massage to the outside unblock the flow of lipids from the meibomian glandsbull Preliminary evidence At 3 months-1 year follow-up improved symptoms and signs (secretions TBUT)1-5

1Lane SS et al Cornea 2012 Apr31(4)396-4042Greiner JV Curr Eye Res 2012 Apr37(4)272-83Greiner JV Clin Experiment Ophthalmol 2013 Aug41(6)524-304Finis D et al Ocul Surf 2014 Apr12(2)146-545Finis D et al Cornea 2014 Dec33(12)1265-70

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Intense Pulsed Light (IPL) Lumenis or E-eyeMain effect lower eyelidsHypothesized mechanism of action1) Treat abnormal blood vessels near eyelid to close them off decrease inflammation2) Thermal treatment softens the glands and allows to discharge secretions more readilySome evidence of therapeutic potential but further studies needed1-2

1Toyos R et al Photomed Laser Surg 2015 January 1 33(1) 41ndash462Craig JP et al Invest Ophthalmol Vis Sci 2015 Feb 1256(3)1965-70 doi 101167iovs14-15764

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iLuxreg Tear Film Innovationsbull Main effect unblocks Meibomian glandsbull Heat amp pressure therapybull 8-12 min treatmentbull Handheld Devicebull Glands can be viewed via magnifier

bull No clinically significant differences between iLux and LipiFlow with respect to indication for use and device performance1

1ldquo510(K) SUMMARY ndash K172645rdquo US Food amp Drug Administration Dec 2017 wwwaccessdatafdagovcdrh_docspdf17K172645pdf

2018

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BlephExreg Rysurgbull FDA clearance bull Main effect lid margin debridement bull 6-8 minute treatmentbull In-officebull Lasts three to six months before requiring a

retreatmentbull Evidence of improvement for contact lens

wearers through significant reduction in bacterial load on patientsrsquo eyelids1

1Siddireddy JS Tan-Showyin J Vijay AK Willcox M A Comfortable Eye Needs Fats Presented at the University of New South Wales Sydney Australia 2015

Rysurgcom

2018

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Blephasteamreg Laboratoires Theacuteabull Main effect warming goggles that promote fluidization Meibomian glands secretions through heat and pressure bull ESPOIR Study evidence of significant improvement in symptoms using the visual analogous scale (VAS)1

bull Expensive devicebull Need further studies with larger samples sizes

to determine efficacy2

1 Doan S Chiambaretta F Gabison EE Cochereau I Baudoin C Efficacy of heating wet chamber warming goggles (Blephasteamreg) in adult posterior blepharitis Invest Opthalmol Vis Sci 201152 E-Abstract 38332Benitez Del Castillo JM Kaercher T Mansour K Wylegala E Dua H Evaluation of the efficacy safety and acceptability of an eyelid warming device for the treatment of meibomian gland dysfunction Clin Ophthalmol 201482019ndash2027

2018

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NuLidstrade NuSight

bull Main effect lid scrub that stimulates Meibomian glands by removing biofilm and scurf that block the opening of the glands

bull Doctor-prescribed In-home treatmentbull 60 second daily treatmentbull A multi-center clinical study showed

evidence of 50 decrease in dry eye symptoms 65 improvement in TBUT and 81 improvement in Meibomian Gland liquid secretions1

1Schanzlin Olkowski Coble Gross NuLids II Study April 2018

2018

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TearCare System Sight Sciences

bull First wearable therapeutic eyelid therapy devicebull In-office treatmentbull 12 minute thermal eyelid treatment followed by expression forceps to

manually evacuate residual obstructionsbull Evidence from pilot study suggested improved TBUT corneal and

conjunctival staining scored and dry eye symptoms based on OSDI SPEED and SANDE1

bull Further clinical evidence underway

Badawi David A novel system TearCarereg for the treatment of the signs and symptoms of dry eye disease Clinical Ophthalmology (Auckland NZ) 12 (2018) 683

2018

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Anti-Inflammatory Pharmaceuticals

Cyclosporine

Main effectbull Anti-inflammatory therapy

bull Inhibits T-cell maturation

bull Decreases pro-inflammatory cytokines

bull Upregulates anti-inflammatory cytokines20

18 copy

48th

Europ

ean C

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s Soc

iety O

f Oph

thalm

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ny re

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proh

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Cyclosporine A cationic emulsion 01 (Ikervisreg Santen)

bull Approved in Europe in 2015bull Main effect prolonged precorneal residence time and improved

bioavailabilityo Indicated for patients with severe DED that has not improved

using tear substitutesbull Clinical evidence of reduced HLA-DR expression at 6 mo measured

through impression cytology overall greater benefits for patients with Sjoumlgrenrsquos Syndrome1

1Leonardi A Messmer EM Labetoulle M et al Efficacy and safety of 01 ciclosporin A cationic emulsion in dry eye disease a pooled analysis of two double-masked randomised vehicle-controlled phase III clinical studies Br J Ophthalmol 2018

2018

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Cyclosporine 009 (OTX-101 CequaTM Sun Pharma)

bull FDA Approval Aug 2018

bull Highest FDA-approved concentration of cyclosporine A1

bull Main effect Increase tear production

bull Calcineurin inhibitor

bull Nanomicellar formulation eases entry into corneal and conjunctival cells

bull Two multicenter studies report a statistically significant increase (ge 10 mm) in Schirmer wetting at 3 mo in patients receiving CequaTM vs vehicle1

Cyclosporine - New Preparations

Biospacecom

1epgonlineorg ldquoFDA Approves CEQUA to Treat Dry Eye Syndrome- Sun Pharma + Sun Ophthalmicsrdquo Epgonlineorg Aug 2018 wwwepgonlineorgusnewsfda-approves-cequa-to-treat-dry-eye-syndrome---sun-pharma---sun--ophthalmics-html

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Cyclosporine 005 and 01 (CyclASol Novaliq)

bull Semifluorinated alkanes formulation better dissolves Cyclosporine Abull Greater penetration than FDA-approved 005 Cyclosporine A

(Restasis)bull Evidence of decreased corneal and conjunctival staining after 14

days2

bull It remains unknown whether greater concentration leads to better results phase 3 studies are underway3

2Novaliq CyclASolreg ndash Cyclosporine in SFA for Ophthalmological Application to Treat Dry Eye Syndrome 20153 Lallemand F Shmitt M Bourges JL et al Cyclosporine A delivery to the eye a comprehensive review of academic and industrial efforts Eur J Pharm Biopharm 201711714-28

2018

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Cyclosporin with chondroiton sulphate

Klarity- C

Imprimis- compounded

chondroitin sulfate

2018

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SkQ1 bull Main effects synthesized small molecule targeted to reduce oxidative stress in cellmitochondria

o Regenerates itself o SkQ1 ophthalmic solution is indicated for pathologies of the eye associated with

oxidative stress such as dry eye 1

o Approved in Russia (2011) and marketed as Visomitinbull Clinical evidence suggest statistically significant 2

o Decrease in corneal stainingo Improvements in lid margin rednesso Improvements in symptoms measuredo through Ora CalibraTM scales

1Wakamatsu TH Dogru M Tsubota K Tearful relations oxidative stress inflammation and eye diseases Arq Bras Oftalmol 200871(6 Suppl)72ndash92Petrov Anton et al SkQ1 ophthalmic solution for dry eye treatment results of a phase 2 safety and efficacy clinical study in the environment and during challenge in the controlled adverse environment model Advances in therapy 331 (2016) 96-115

2018

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Steroids- new formulation bullKPI-121- Kala Pharmaceuticals

bullMucous ndash penetrating particle ( MPP) ndashbullnano particles

bullLoteprednol -025

bull Better penetration low dose steroid

bullEpisodic flare ups of DED

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ADX-102 (Reproxalap Aldeyra Therapeutics)bull Small molecule topical agentbull Traps aldehydes that usually activate inflammatory factorsbull Positive clinical evidence of improvement in signs and

symptoms of dry eye1

Thymosin beta 4 (Tβ4 ) bull 43-amino acid G-actin binding proteinbull Downregulates transcription of inflammatory mediators and promotes corneal

epithelial cell migrationbull Phase 3 clinical trial with Tβ4 (RGN-259 RegeneRx) showed improvement in signs

and symptoms of dry eye through corneal staining tear production and expression of inflammatory factors2

1Aldehyde trap drug rapidly improves signs symptoms of dry eye disease American Academy of Ophthalmology (2017) httpswwwaaoorgheadlinealdehyde-trap-drug-rapidly-improves-signs-symptoms2Kim Chae Eun et al RGN-259 (thymosin β4) improves clinically important dry eye efficacies in comparison with prescription drugs in a dry eye model Scientific reports 81 (2018) 10500

Aldeyracom

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Tear Enhancements

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bull Currently approved in Japan and South Korea1

bull Main Effect Increase tear fluid and mucin secretion on the ocular surface through interaction with P2Y2 receptors in the conjunctiva

bull Evidence from clinical trials suggest diquafosol improves corneal staining more effectively than a comparable sodium hyaluronate solution2

Diquafosol Tetrasodium(3 Ophthalmic Solution)

1Koh Shizuka Clinical utility of 3 diquafosol ophthalmic solution in the treatment of dry eyes Clinical Ophthalmology (Auckland NZ) 9 (2015) 8652Takamura Etsuko et al A randomised double-masked comparison study of diquafosol versus sodium hyaluronate ophthalmic solutions in dry eye patients British Journal of Ophthalmology 9610 (2012) 1310-1315

Pubmedcom

Santencom

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Rebapimide

(2 Ophthalmic Solution)

bull Currently approved in Japanbull Main Effect stimulates mucin secretagogue activity in

cornea and conjunctivabull Clinical evidence suggests

o Statistically significant Improvement in corneal and conjunctival staining as well as in quality of life as well as in tear break-up time12

o Potential role in suppressing the expression of inflammatory proteins (Polyl)3

1 Kinoshita Shigeru et al Rebamipide (OPC-12759) in the treatment of dry eye a randomized double-masked multicenter placebo-controlled phase II study Ophthalmology11912 (2012) 2471-24782 Kashima Tomoyuki et al Rebamipide ophthalmic suspension for the treatment of dry eye syndrome a critical appraisal Clinical ophthalmology (Auckland NZ) 8 (2014) 10033Ueta Mayumi et al Rebamipide suppresses PolyI C-stimulated cytokine production in human conjunctival epithelial cells Journal of Ocular Pharmacology and Therapeutics 297 (2013) 688-693

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TrueTearreg Allerganbull FDA Clearancebull Main effect intranasal applicator sends

electrical currents to nerves that stimulate tear production

bull Evidence of improved Schirmer scores decreased symptoms and corneal and conjunctival staining at 6 mo Ocular comfort lasted for 3 hours following neurostimulationo Secondary effect intranasal application

promotes goblet cell mucin secretion which stabilizes the tear film1

Truetearcom

1Gumus K Schuetzle KL Pflugfelder SC Randomized controlled crossover trial comparing the impact of sham or intranasal tear neurostimulation on 654 GD Novack et al The Ocular Surface xxx (2017) 635e655 conjunctival goblet cell degranulation Am J Ophthalmol 2017177159e68

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Pharmaceutical to stimulate nerves

bullNasal Spray OC-01

bullOyster Point Pharma

bullStimulate natural tears

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Amniotic cytokine extract(Ocular Science)bullACE is a novel drop marketed as Genesis bullContains various cytokines growth factor

and anti-inflammatory moleculesbull Effective in a small pilot study

Amniotic Cytokine Extract Promising in Patients with Dry Ey Disease MDLinx

httpswwwmdlinxcomophthalmologyarticle1280 1113088 Accessed Jan 27 2018

Amniotic Cytokine Extract Promising in Patients with Dry Ey Disease MDLinx

httpswwwmdlinxcomophthalmologyarticle1280 1113088 Accessed Jan 27 2

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Recombinant human nerve growth factor (OxervateTM eye drops Dompeacute)

bull FDA Approval Aug 2018o First approved drug for Neurotropic keratitis (NK) ndashdegenerative disease with loss of corneal sensation o Topical eye drop o Clinical evidence of complete corneal healing in 70 of patients treated with Oxervate after 8 weeks1

1Bonini S et al Phase II Randomized Double-Masked Vehicle-Controlled Trial of Recombinant Human Nerve Growth Factor for Neurotrophic Keratitis Ophthalmology 125 1332ndash1343 (2018)

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Perfluorohexyloctane (NovaTears Novaliq)

bull Main effect prevent evaporative DED by increasing tear film and lipid layer thickness

bull Approved in Europe Australia and New Zealandbull Clinical evidence of increased tear production and tear film

stability as well as significant decrease in OSDI scores and in corneal staining1

1Steven P et al Semifluorinated Alkane Eye Drops for Treatment of Dry Eye Disease ndash A Prospective Multicenter Noninterventional Study J Ocul Pharmacol Ther 2015 Oct 1 31(8) 498-503

Corneal Epithelium Healing

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CrossThiolated Carboxymethyl Hyaluronic Acid Liquid-Gel

(Ocular Bandage Gel EyeGate Pharma)

bull Main effects accelerate corneal healing and reduce corneal stainingo Indicated for defects due to photorefcrative keratectomy (PRK)o Indicated for Punctate epitheliopathies (PE) associated with

dry eyebull Treatment in development July 2018 approval to conduct two

pilot studies using OBG for PE and PRKbull A first-in-human pilot study (n=39) showed accelerated corneal

reepithelialization through slit lamp examination at day 1 after PRK Further studies needed1

1Durrie Daniel S et al Ability of a new crosslinked polymer ocular bandage gel to accelerate reepithelialization after photorefractive keratectomy Journal of Cataract amp Refractive Surgery 443 (2018) 369-375

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Biologic MoleculesDry Eye Assessment

bull Proteoglycan-4 (Lubricin)oRecently discovered on the ocular surface in the meibomian glands2

oFunctions to prevent friction at the cornea-lid interface and has anti-inflammatory propertiesoCommercial lubricin-based lubricants remain scarceoEvidence from clinical studies with recombinant human lubricin suggest

significant improvement in signs and symptoms of DED through TBUT corneal staining and eyelid and conjunctival redness3

1De Paiva CS Chotikavanich S Pangelinan SB Pitcher 3rd JD Fang B Zheng X et al IL-17 disrupts corneal barrier following desiccating stress Mucosal Immunol 20092(3)243ndash2532Iqbal SM Leonard C Regmi SC De Rantere D Tailor P Ren G et al LubricinProteoglycan 4 binds to and regulates the activity of Toll-Like Receptors In Vitro Sci Rep20166189103Lambiase A Sullivan BD Schmidt TA Sullivan DA Jay GD Truitt ER et al A Two-Week Randomized Double-masked Study to Evaluate Safety and Efficacy of Lubricin

(150 mugmL) Eye Drops Versus Sodium Hyaluronate (HA) 018 Eye Drops (Vismed(R)) in Patients with Moderate Dry Eye Disease Ocul Surf 20171577ndash87

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Why Ocular Biomarkers

Surrogate Endpoints- None accepted by the FDA or Europe to date Validation needed- clear clinical relevance

Enrichment of Study Population Still regulatory hurdles

Support mechanism of action of treatment Topical ciclosporin in Europe for Dry eyes (Europe2015 Ikervis)1

SEGMENT THE DRY EYE POPULATION- TREAT MORE SPECIFICALLY-PERSONALIZE TREATMENT

1 Ikervis SmPC June 2015 available at httpswwwmedicinesorgukemcmedicine30584

2018

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DED Overview

bull DREAM Study Results

bull New Dry Eye Treatment Optionso Lids- MGDoAnti- inflammatoriesoTear composition

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Patient Population and TreatmentBroad spectrum of symptomatic patients with moderate or severe DED

REAL WORLD PATIENTS

Can continue current treatment

Symptoms for at least 6 months

Signs at screening visit and eligibility confirmation visit

bull Supplements ndash 5 softgels per day

bull Active ndash 3 gm ω3 per day

bull 2 gm EPA + 1 gm DHA

bull Fish oil concentrate (triglyceride)

bull Placebo - 5 gm olive oil per day

bull Identical in size color aroma

bull Fish essence added to placebo

bull Lemon essence to both to mask fish odor

bull 15mg Vitamin E as an anti-oxidant

The Dry Eye Assessment and Management Study

2018

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Study Visits and Treatment Assignment

Screening

Eligibility Confirmation

Randomization

Placebo

3 Months

6 Months

12 Months

Active ω3

3 Months

6 Months

12 Months

23 13

535 Subjects

2018

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Mean Scores of Signs Over TimeMean Change in OSDI Score Over Time

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DREAM Results

When patients who had moderate to severe dry eye disease despite use of other treatments were randomly assigned to ω3 or placebo supplements mean values for symptoms and signs improved

However we found no evidence of a beneficial effect of ω3 supplements on the symptoms and signs DED relative to placebo supplements

A therapeutic effect of 1 teaspoon of refined olive oil daily is not plausible1

1 Abell Penny A and Maureen G Maguire ldquonminus3 Fatty Acid Supplementation and Dry Eye Diseaserdquo New England Journal of Medicine vol 379 no 7 2018 pp 690ndash691

2018

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Strengths of DREAM

bullGeneralizability ω3 added to existing treatments in patients who still had symptoms and signs despite Rx ndash REAL WORLD PATIENTSbullComparability of Groups Randomization ldquoworkedrdquobullCompliance

bull Drugs delivered to home even when missed visit

bull High rates of compliance by blood testbull Missed visit rate lt 10

bull Treatment bull Highest dose (3000 mg) of ω3 in any DED RCTbull Triglyceride ω3 form more bioavailable than ethyl esterbull Content verified by an outside laboratorybull Softgels active identical to placebobull 12 months ndash reduce seasonality effects

2018

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New Treatment Options

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Meibomian Gland Dysfunctionbull A leading cause of Dry Eye1

bull Clinical signs of MGD2o Aberrant medium production andor composition due to Obstruction of meibomian gland (a) Gland dropout (b) Change in gland secretion (c)

bull Patients complaining of repeated lsquostyesrsquo

bull Characterized by tear film instability and rapid TFBUT1Nichols KK Foulks GN Bron AJ et al The International Workshop on Meibomian Gland Dysfunction Executive Summary

Investigative Ophthalmology amp Visual Science 201152(4)1922-19292American Academy of Ophthalmology Retina Panel Preferred Practice PatternregGuidelines Blepharitis San Francisco

CA American Academy of Ophthalmology 2008 Available at httpwwwaaoorgppp

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Meibomian Gland Dysfunction - Treatments

Heating amp Pressure Devices

bull Lipiflow

bull Intense Pulsed Light (IPL)

bull iLux

bull Blephex

bull NuLids

bull Blephasteam

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LipiFlowreg TearScience

bull FDA clearancebull Thermal pulsation Devicebull 12 minute treatmentbull Delivers heat to the inner eyelid and massage to the outside unblock the flow of lipids from the meibomian glandsbull Preliminary evidence At 3 months-1 year follow-up improved symptoms and signs (secretions TBUT)1-5

1Lane SS et al Cornea 2012 Apr31(4)396-4042Greiner JV Curr Eye Res 2012 Apr37(4)272-83Greiner JV Clin Experiment Ophthalmol 2013 Aug41(6)524-304Finis D et al Ocul Surf 2014 Apr12(2)146-545Finis D et al Cornea 2014 Dec33(12)1265-70

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Intense Pulsed Light (IPL) Lumenis or E-eyeMain effect lower eyelidsHypothesized mechanism of action1) Treat abnormal blood vessels near eyelid to close them off decrease inflammation2) Thermal treatment softens the glands and allows to discharge secretions more readilySome evidence of therapeutic potential but further studies needed1-2

1Toyos R et al Photomed Laser Surg 2015 January 1 33(1) 41ndash462Craig JP et al Invest Ophthalmol Vis Sci 2015 Feb 1256(3)1965-70 doi 101167iovs14-15764

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iLuxreg Tear Film Innovationsbull Main effect unblocks Meibomian glandsbull Heat amp pressure therapybull 8-12 min treatmentbull Handheld Devicebull Glands can be viewed via magnifier

bull No clinically significant differences between iLux and LipiFlow with respect to indication for use and device performance1

1ldquo510(K) SUMMARY ndash K172645rdquo US Food amp Drug Administration Dec 2017 wwwaccessdatafdagovcdrh_docspdf17K172645pdf

2018

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BlephExreg Rysurgbull FDA clearance bull Main effect lid margin debridement bull 6-8 minute treatmentbull In-officebull Lasts three to six months before requiring a

retreatmentbull Evidence of improvement for contact lens

wearers through significant reduction in bacterial load on patientsrsquo eyelids1

1Siddireddy JS Tan-Showyin J Vijay AK Willcox M A Comfortable Eye Needs Fats Presented at the University of New South Wales Sydney Australia 2015

Rysurgcom

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Blephasteamreg Laboratoires Theacuteabull Main effect warming goggles that promote fluidization Meibomian glands secretions through heat and pressure bull ESPOIR Study evidence of significant improvement in symptoms using the visual analogous scale (VAS)1

bull Expensive devicebull Need further studies with larger samples sizes

to determine efficacy2

1 Doan S Chiambaretta F Gabison EE Cochereau I Baudoin C Efficacy of heating wet chamber warming goggles (Blephasteamreg) in adult posterior blepharitis Invest Opthalmol Vis Sci 201152 E-Abstract 38332Benitez Del Castillo JM Kaercher T Mansour K Wylegala E Dua H Evaluation of the efficacy safety and acceptability of an eyelid warming device for the treatment of meibomian gland dysfunction Clin Ophthalmol 201482019ndash2027

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NuLidstrade NuSight

bull Main effect lid scrub that stimulates Meibomian glands by removing biofilm and scurf that block the opening of the glands

bull Doctor-prescribed In-home treatmentbull 60 second daily treatmentbull A multi-center clinical study showed

evidence of 50 decrease in dry eye symptoms 65 improvement in TBUT and 81 improvement in Meibomian Gland liquid secretions1

1Schanzlin Olkowski Coble Gross NuLids II Study April 2018

2018

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TearCare System Sight Sciences

bull First wearable therapeutic eyelid therapy devicebull In-office treatmentbull 12 minute thermal eyelid treatment followed by expression forceps to

manually evacuate residual obstructionsbull Evidence from pilot study suggested improved TBUT corneal and

conjunctival staining scored and dry eye symptoms based on OSDI SPEED and SANDE1

bull Further clinical evidence underway

Badawi David A novel system TearCarereg for the treatment of the signs and symptoms of dry eye disease Clinical Ophthalmology (Auckland NZ) 12 (2018) 683

2018

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Anti-Inflammatory Pharmaceuticals

Cyclosporine

Main effectbull Anti-inflammatory therapy

bull Inhibits T-cell maturation

bull Decreases pro-inflammatory cytokines

bull Upregulates anti-inflammatory cytokines20

18 copy

48th

Europ

ean C

ontac

t Len

s Soc

iety O

f Oph

thalm

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ts A

ll righ

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serve

d - A

ny re

prod

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art is

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Cyclosporine A cationic emulsion 01 (Ikervisreg Santen)

bull Approved in Europe in 2015bull Main effect prolonged precorneal residence time and improved

bioavailabilityo Indicated for patients with severe DED that has not improved

using tear substitutesbull Clinical evidence of reduced HLA-DR expression at 6 mo measured

through impression cytology overall greater benefits for patients with Sjoumlgrenrsquos Syndrome1

1Leonardi A Messmer EM Labetoulle M et al Efficacy and safety of 01 ciclosporin A cationic emulsion in dry eye disease a pooled analysis of two double-masked randomised vehicle-controlled phase III clinical studies Br J Ophthalmol 2018

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Cyclosporine 009 (OTX-101 CequaTM Sun Pharma)

bull FDA Approval Aug 2018

bull Highest FDA-approved concentration of cyclosporine A1

bull Main effect Increase tear production

bull Calcineurin inhibitor

bull Nanomicellar formulation eases entry into corneal and conjunctival cells

bull Two multicenter studies report a statistically significant increase (ge 10 mm) in Schirmer wetting at 3 mo in patients receiving CequaTM vs vehicle1

Cyclosporine - New Preparations

Biospacecom

1epgonlineorg ldquoFDA Approves CEQUA to Treat Dry Eye Syndrome- Sun Pharma + Sun Ophthalmicsrdquo Epgonlineorg Aug 2018 wwwepgonlineorgusnewsfda-approves-cequa-to-treat-dry-eye-syndrome---sun-pharma---sun--ophthalmics-html

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Cyclosporine 005 and 01 (CyclASol Novaliq)

bull Semifluorinated alkanes formulation better dissolves Cyclosporine Abull Greater penetration than FDA-approved 005 Cyclosporine A

(Restasis)bull Evidence of decreased corneal and conjunctival staining after 14

days2

bull It remains unknown whether greater concentration leads to better results phase 3 studies are underway3

2Novaliq CyclASolreg ndash Cyclosporine in SFA for Ophthalmological Application to Treat Dry Eye Syndrome 20153 Lallemand F Shmitt M Bourges JL et al Cyclosporine A delivery to the eye a comprehensive review of academic and industrial efforts Eur J Pharm Biopharm 201711714-28

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Cyclosporin with chondroiton sulphate

Klarity- C

Imprimis- compounded

chondroitin sulfate

2018

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SkQ1 bull Main effects synthesized small molecule targeted to reduce oxidative stress in cellmitochondria

o Regenerates itself o SkQ1 ophthalmic solution is indicated for pathologies of the eye associated with

oxidative stress such as dry eye 1

o Approved in Russia (2011) and marketed as Visomitinbull Clinical evidence suggest statistically significant 2

o Decrease in corneal stainingo Improvements in lid margin rednesso Improvements in symptoms measuredo through Ora CalibraTM scales

1Wakamatsu TH Dogru M Tsubota K Tearful relations oxidative stress inflammation and eye diseases Arq Bras Oftalmol 200871(6 Suppl)72ndash92Petrov Anton et al SkQ1 ophthalmic solution for dry eye treatment results of a phase 2 safety and efficacy clinical study in the environment and during challenge in the controlled adverse environment model Advances in therapy 331 (2016) 96-115

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Steroids- new formulation bullKPI-121- Kala Pharmaceuticals

bullMucous ndash penetrating particle ( MPP) ndashbullnano particles

bullLoteprednol -025

bull Better penetration low dose steroid

bullEpisodic flare ups of DED

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ADX-102 (Reproxalap Aldeyra Therapeutics)bull Small molecule topical agentbull Traps aldehydes that usually activate inflammatory factorsbull Positive clinical evidence of improvement in signs and

symptoms of dry eye1

Thymosin beta 4 (Tβ4 ) bull 43-amino acid G-actin binding proteinbull Downregulates transcription of inflammatory mediators and promotes corneal

epithelial cell migrationbull Phase 3 clinical trial with Tβ4 (RGN-259 RegeneRx) showed improvement in signs

and symptoms of dry eye through corneal staining tear production and expression of inflammatory factors2

1Aldehyde trap drug rapidly improves signs symptoms of dry eye disease American Academy of Ophthalmology (2017) httpswwwaaoorgheadlinealdehyde-trap-drug-rapidly-improves-signs-symptoms2Kim Chae Eun et al RGN-259 (thymosin β4) improves clinically important dry eye efficacies in comparison with prescription drugs in a dry eye model Scientific reports 81 (2018) 10500

Aldeyracom

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Tear Enhancements

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bull Currently approved in Japan and South Korea1

bull Main Effect Increase tear fluid and mucin secretion on the ocular surface through interaction with P2Y2 receptors in the conjunctiva

bull Evidence from clinical trials suggest diquafosol improves corneal staining more effectively than a comparable sodium hyaluronate solution2

Diquafosol Tetrasodium(3 Ophthalmic Solution)

1Koh Shizuka Clinical utility of 3 diquafosol ophthalmic solution in the treatment of dry eyes Clinical Ophthalmology (Auckland NZ) 9 (2015) 8652Takamura Etsuko et al A randomised double-masked comparison study of diquafosol versus sodium hyaluronate ophthalmic solutions in dry eye patients British Journal of Ophthalmology 9610 (2012) 1310-1315

Pubmedcom

Santencom

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Rebapimide

(2 Ophthalmic Solution)

bull Currently approved in Japanbull Main Effect stimulates mucin secretagogue activity in

cornea and conjunctivabull Clinical evidence suggests

o Statistically significant Improvement in corneal and conjunctival staining as well as in quality of life as well as in tear break-up time12

o Potential role in suppressing the expression of inflammatory proteins (Polyl)3

1 Kinoshita Shigeru et al Rebamipide (OPC-12759) in the treatment of dry eye a randomized double-masked multicenter placebo-controlled phase II study Ophthalmology11912 (2012) 2471-24782 Kashima Tomoyuki et al Rebamipide ophthalmic suspension for the treatment of dry eye syndrome a critical appraisal Clinical ophthalmology (Auckland NZ) 8 (2014) 10033Ueta Mayumi et al Rebamipide suppresses PolyI C-stimulated cytokine production in human conjunctival epithelial cells Journal of Ocular Pharmacology and Therapeutics 297 (2013) 688-693

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TrueTearreg Allerganbull FDA Clearancebull Main effect intranasal applicator sends

electrical currents to nerves that stimulate tear production

bull Evidence of improved Schirmer scores decreased symptoms and corneal and conjunctival staining at 6 mo Ocular comfort lasted for 3 hours following neurostimulationo Secondary effect intranasal application

promotes goblet cell mucin secretion which stabilizes the tear film1

Truetearcom

1Gumus K Schuetzle KL Pflugfelder SC Randomized controlled crossover trial comparing the impact of sham or intranasal tear neurostimulation on 654 GD Novack et al The Ocular Surface xxx (2017) 635e655 conjunctival goblet cell degranulation Am J Ophthalmol 2017177159e68

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Pharmaceutical to stimulate nerves

bullNasal Spray OC-01

bullOyster Point Pharma

bullStimulate natural tears

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Amniotic cytokine extract(Ocular Science)bullACE is a novel drop marketed as Genesis bullContains various cytokines growth factor

and anti-inflammatory moleculesbull Effective in a small pilot study

Amniotic Cytokine Extract Promising in Patients with Dry Ey Disease MDLinx

httpswwwmdlinxcomophthalmologyarticle1280 1113088 Accessed Jan 27 2018

Amniotic Cytokine Extract Promising in Patients with Dry Ey Disease MDLinx

httpswwwmdlinxcomophthalmologyarticle1280 1113088 Accessed Jan 27 2

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Recombinant human nerve growth factor (OxervateTM eye drops Dompeacute)

bull FDA Approval Aug 2018o First approved drug for Neurotropic keratitis (NK) ndashdegenerative disease with loss of corneal sensation o Topical eye drop o Clinical evidence of complete corneal healing in 70 of patients treated with Oxervate after 8 weeks1

1Bonini S et al Phase II Randomized Double-Masked Vehicle-Controlled Trial of Recombinant Human Nerve Growth Factor for Neurotrophic Keratitis Ophthalmology 125 1332ndash1343 (2018)

2018

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Perfluorohexyloctane (NovaTears Novaliq)

bull Main effect prevent evaporative DED by increasing tear film and lipid layer thickness

bull Approved in Europe Australia and New Zealandbull Clinical evidence of increased tear production and tear film

stability as well as significant decrease in OSDI scores and in corneal staining1

1Steven P et al Semifluorinated Alkane Eye Drops for Treatment of Dry Eye Disease ndash A Prospective Multicenter Noninterventional Study J Ocul Pharmacol Ther 2015 Oct 1 31(8) 498-503

Corneal Epithelium Healing

2018

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CrossThiolated Carboxymethyl Hyaluronic Acid Liquid-Gel

(Ocular Bandage Gel EyeGate Pharma)

bull Main effects accelerate corneal healing and reduce corneal stainingo Indicated for defects due to photorefcrative keratectomy (PRK)o Indicated for Punctate epitheliopathies (PE) associated with

dry eyebull Treatment in development July 2018 approval to conduct two

pilot studies using OBG for PE and PRKbull A first-in-human pilot study (n=39) showed accelerated corneal

reepithelialization through slit lamp examination at day 1 after PRK Further studies needed1

1Durrie Daniel S et al Ability of a new crosslinked polymer ocular bandage gel to accelerate reepithelialization after photorefractive keratectomy Journal of Cataract amp Refractive Surgery 443 (2018) 369-375

2018

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Biologic MoleculesDry Eye Assessment

bull Proteoglycan-4 (Lubricin)oRecently discovered on the ocular surface in the meibomian glands2

oFunctions to prevent friction at the cornea-lid interface and has anti-inflammatory propertiesoCommercial lubricin-based lubricants remain scarceoEvidence from clinical studies with recombinant human lubricin suggest

significant improvement in signs and symptoms of DED through TBUT corneal staining and eyelid and conjunctival redness3

1De Paiva CS Chotikavanich S Pangelinan SB Pitcher 3rd JD Fang B Zheng X et al IL-17 disrupts corneal barrier following desiccating stress Mucosal Immunol 20092(3)243ndash2532Iqbal SM Leonard C Regmi SC De Rantere D Tailor P Ren G et al LubricinProteoglycan 4 binds to and regulates the activity of Toll-Like Receptors In Vitro Sci Rep20166189103Lambiase A Sullivan BD Schmidt TA Sullivan DA Jay GD Truitt ER et al A Two-Week Randomized Double-masked Study to Evaluate Safety and Efficacy of Lubricin

(150 mugmL) Eye Drops Versus Sodium Hyaluronate (HA) 018 Eye Drops (Vismed(R)) in Patients with Moderate Dry Eye Disease Ocul Surf 20171577ndash87

2018

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Why Ocular Biomarkers

Surrogate Endpoints- None accepted by the FDA or Europe to date Validation needed- clear clinical relevance

Enrichment of Study Population Still regulatory hurdles

Support mechanism of action of treatment Topical ciclosporin in Europe for Dry eyes (Europe2015 Ikervis)1

SEGMENT THE DRY EYE POPULATION- TREAT MORE SPECIFICALLY-PERSONALIZE TREATMENT

1 Ikervis SmPC June 2015 available at httpswwwmedicinesorgukemcmedicine30584

2018

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Patient Population and TreatmentBroad spectrum of symptomatic patients with moderate or severe DED

REAL WORLD PATIENTS

Can continue current treatment

Symptoms for at least 6 months

Signs at screening visit and eligibility confirmation visit

bull Supplements ndash 5 softgels per day

bull Active ndash 3 gm ω3 per day

bull 2 gm EPA + 1 gm DHA

bull Fish oil concentrate (triglyceride)

bull Placebo - 5 gm olive oil per day

bull Identical in size color aroma

bull Fish essence added to placebo

bull Lemon essence to both to mask fish odor

bull 15mg Vitamin E as an anti-oxidant

The Dry Eye Assessment and Management Study

2018

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Study Visits and Treatment Assignment

Screening

Eligibility Confirmation

Randomization

Placebo

3 Months

6 Months

12 Months

Active ω3

3 Months

6 Months

12 Months

23 13

535 Subjects

2018

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Mean Scores of Signs Over TimeMean Change in OSDI Score Over Time

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DREAM Results

When patients who had moderate to severe dry eye disease despite use of other treatments were randomly assigned to ω3 or placebo supplements mean values for symptoms and signs improved

However we found no evidence of a beneficial effect of ω3 supplements on the symptoms and signs DED relative to placebo supplements

A therapeutic effect of 1 teaspoon of refined olive oil daily is not plausible1

1 Abell Penny A and Maureen G Maguire ldquonminus3 Fatty Acid Supplementation and Dry Eye Diseaserdquo New England Journal of Medicine vol 379 no 7 2018 pp 690ndash691

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Strengths of DREAM

bullGeneralizability ω3 added to existing treatments in patients who still had symptoms and signs despite Rx ndash REAL WORLD PATIENTSbullComparability of Groups Randomization ldquoworkedrdquobullCompliance

bull Drugs delivered to home even when missed visit

bull High rates of compliance by blood testbull Missed visit rate lt 10

bull Treatment bull Highest dose (3000 mg) of ω3 in any DED RCTbull Triglyceride ω3 form more bioavailable than ethyl esterbull Content verified by an outside laboratorybull Softgels active identical to placebobull 12 months ndash reduce seasonality effects

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New Treatment Options

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Meibomian Gland Dysfunctionbull A leading cause of Dry Eye1

bull Clinical signs of MGD2o Aberrant medium production andor composition due to Obstruction of meibomian gland (a) Gland dropout (b) Change in gland secretion (c)

bull Patients complaining of repeated lsquostyesrsquo

bull Characterized by tear film instability and rapid TFBUT1Nichols KK Foulks GN Bron AJ et al The International Workshop on Meibomian Gland Dysfunction Executive Summary

Investigative Ophthalmology amp Visual Science 201152(4)1922-19292American Academy of Ophthalmology Retina Panel Preferred Practice PatternregGuidelines Blepharitis San Francisco

CA American Academy of Ophthalmology 2008 Available at httpwwwaaoorgppp

2018

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Meibomian Gland Dysfunction - Treatments

Heating amp Pressure Devices

bull Lipiflow

bull Intense Pulsed Light (IPL)

bull iLux

bull Blephex

bull NuLids

bull Blephasteam

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LipiFlowreg TearScience

bull FDA clearancebull Thermal pulsation Devicebull 12 minute treatmentbull Delivers heat to the inner eyelid and massage to the outside unblock the flow of lipids from the meibomian glandsbull Preliminary evidence At 3 months-1 year follow-up improved symptoms and signs (secretions TBUT)1-5

1Lane SS et al Cornea 2012 Apr31(4)396-4042Greiner JV Curr Eye Res 2012 Apr37(4)272-83Greiner JV Clin Experiment Ophthalmol 2013 Aug41(6)524-304Finis D et al Ocul Surf 2014 Apr12(2)146-545Finis D et al Cornea 2014 Dec33(12)1265-70

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Intense Pulsed Light (IPL) Lumenis or E-eyeMain effect lower eyelidsHypothesized mechanism of action1) Treat abnormal blood vessels near eyelid to close them off decrease inflammation2) Thermal treatment softens the glands and allows to discharge secretions more readilySome evidence of therapeutic potential but further studies needed1-2

1Toyos R et al Photomed Laser Surg 2015 January 1 33(1) 41ndash462Craig JP et al Invest Ophthalmol Vis Sci 2015 Feb 1256(3)1965-70 doi 101167iovs14-15764

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iLuxreg Tear Film Innovationsbull Main effect unblocks Meibomian glandsbull Heat amp pressure therapybull 8-12 min treatmentbull Handheld Devicebull Glands can be viewed via magnifier

bull No clinically significant differences between iLux and LipiFlow with respect to indication for use and device performance1

1ldquo510(K) SUMMARY ndash K172645rdquo US Food amp Drug Administration Dec 2017 wwwaccessdatafdagovcdrh_docspdf17K172645pdf

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BlephExreg Rysurgbull FDA clearance bull Main effect lid margin debridement bull 6-8 minute treatmentbull In-officebull Lasts three to six months before requiring a

retreatmentbull Evidence of improvement for contact lens

wearers through significant reduction in bacterial load on patientsrsquo eyelids1

1Siddireddy JS Tan-Showyin J Vijay AK Willcox M A Comfortable Eye Needs Fats Presented at the University of New South Wales Sydney Australia 2015

Rysurgcom

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Blephasteamreg Laboratoires Theacuteabull Main effect warming goggles that promote fluidization Meibomian glands secretions through heat and pressure bull ESPOIR Study evidence of significant improvement in symptoms using the visual analogous scale (VAS)1

bull Expensive devicebull Need further studies with larger samples sizes

to determine efficacy2

1 Doan S Chiambaretta F Gabison EE Cochereau I Baudoin C Efficacy of heating wet chamber warming goggles (Blephasteamreg) in adult posterior blepharitis Invest Opthalmol Vis Sci 201152 E-Abstract 38332Benitez Del Castillo JM Kaercher T Mansour K Wylegala E Dua H Evaluation of the efficacy safety and acceptability of an eyelid warming device for the treatment of meibomian gland dysfunction Clin Ophthalmol 201482019ndash2027

2018

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NuLidstrade NuSight

bull Main effect lid scrub that stimulates Meibomian glands by removing biofilm and scurf that block the opening of the glands

bull Doctor-prescribed In-home treatmentbull 60 second daily treatmentbull A multi-center clinical study showed

evidence of 50 decrease in dry eye symptoms 65 improvement in TBUT and 81 improvement in Meibomian Gland liquid secretions1

1Schanzlin Olkowski Coble Gross NuLids II Study April 2018

2018

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TearCare System Sight Sciences

bull First wearable therapeutic eyelid therapy devicebull In-office treatmentbull 12 minute thermal eyelid treatment followed by expression forceps to

manually evacuate residual obstructionsbull Evidence from pilot study suggested improved TBUT corneal and

conjunctival staining scored and dry eye symptoms based on OSDI SPEED and SANDE1

bull Further clinical evidence underway

Badawi David A novel system TearCarereg for the treatment of the signs and symptoms of dry eye disease Clinical Ophthalmology (Auckland NZ) 12 (2018) 683

2018

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Anti-Inflammatory Pharmaceuticals

Cyclosporine

Main effectbull Anti-inflammatory therapy

bull Inhibits T-cell maturation

bull Decreases pro-inflammatory cytokines

bull Upregulates anti-inflammatory cytokines20

18 copy

48th

Europ

ean C

ontac

t Len

s Soc

iety O

f Oph

thalm

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ts A

ll righ

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d - A

ny re

prod

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art is

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Cyclosporine A cationic emulsion 01 (Ikervisreg Santen)

bull Approved in Europe in 2015bull Main effect prolonged precorneal residence time and improved

bioavailabilityo Indicated for patients with severe DED that has not improved

using tear substitutesbull Clinical evidence of reduced HLA-DR expression at 6 mo measured

through impression cytology overall greater benefits for patients with Sjoumlgrenrsquos Syndrome1

1Leonardi A Messmer EM Labetoulle M et al Efficacy and safety of 01 ciclosporin A cationic emulsion in dry eye disease a pooled analysis of two double-masked randomised vehicle-controlled phase III clinical studies Br J Ophthalmol 2018

2018

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Cyclosporine 009 (OTX-101 CequaTM Sun Pharma)

bull FDA Approval Aug 2018

bull Highest FDA-approved concentration of cyclosporine A1

bull Main effect Increase tear production

bull Calcineurin inhibitor

bull Nanomicellar formulation eases entry into corneal and conjunctival cells

bull Two multicenter studies report a statistically significant increase (ge 10 mm) in Schirmer wetting at 3 mo in patients receiving CequaTM vs vehicle1

Cyclosporine - New Preparations

Biospacecom

1epgonlineorg ldquoFDA Approves CEQUA to Treat Dry Eye Syndrome- Sun Pharma + Sun Ophthalmicsrdquo Epgonlineorg Aug 2018 wwwepgonlineorgusnewsfda-approves-cequa-to-treat-dry-eye-syndrome---sun-pharma---sun--ophthalmics-html

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Cyclosporine 005 and 01 (CyclASol Novaliq)

bull Semifluorinated alkanes formulation better dissolves Cyclosporine Abull Greater penetration than FDA-approved 005 Cyclosporine A

(Restasis)bull Evidence of decreased corneal and conjunctival staining after 14

days2

bull It remains unknown whether greater concentration leads to better results phase 3 studies are underway3

2Novaliq CyclASolreg ndash Cyclosporine in SFA for Ophthalmological Application to Treat Dry Eye Syndrome 20153 Lallemand F Shmitt M Bourges JL et al Cyclosporine A delivery to the eye a comprehensive review of academic and industrial efforts Eur J Pharm Biopharm 201711714-28

2018

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Cyclosporin with chondroiton sulphate

Klarity- C

Imprimis- compounded

chondroitin sulfate

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SkQ1 bull Main effects synthesized small molecule targeted to reduce oxidative stress in cellmitochondria

o Regenerates itself o SkQ1 ophthalmic solution is indicated for pathologies of the eye associated with

oxidative stress such as dry eye 1

o Approved in Russia (2011) and marketed as Visomitinbull Clinical evidence suggest statistically significant 2

o Decrease in corneal stainingo Improvements in lid margin rednesso Improvements in symptoms measuredo through Ora CalibraTM scales

1Wakamatsu TH Dogru M Tsubota K Tearful relations oxidative stress inflammation and eye diseases Arq Bras Oftalmol 200871(6 Suppl)72ndash92Petrov Anton et al SkQ1 ophthalmic solution for dry eye treatment results of a phase 2 safety and efficacy clinical study in the environment and during challenge in the controlled adverse environment model Advances in therapy 331 (2016) 96-115

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Steroids- new formulation bullKPI-121- Kala Pharmaceuticals

bullMucous ndash penetrating particle ( MPP) ndashbullnano particles

bullLoteprednol -025

bull Better penetration low dose steroid

bullEpisodic flare ups of DED

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ADX-102 (Reproxalap Aldeyra Therapeutics)bull Small molecule topical agentbull Traps aldehydes that usually activate inflammatory factorsbull Positive clinical evidence of improvement in signs and

symptoms of dry eye1

Thymosin beta 4 (Tβ4 ) bull 43-amino acid G-actin binding proteinbull Downregulates transcription of inflammatory mediators and promotes corneal

epithelial cell migrationbull Phase 3 clinical trial with Tβ4 (RGN-259 RegeneRx) showed improvement in signs

and symptoms of dry eye through corneal staining tear production and expression of inflammatory factors2

1Aldehyde trap drug rapidly improves signs symptoms of dry eye disease American Academy of Ophthalmology (2017) httpswwwaaoorgheadlinealdehyde-trap-drug-rapidly-improves-signs-symptoms2Kim Chae Eun et al RGN-259 (thymosin β4) improves clinically important dry eye efficacies in comparison with prescription drugs in a dry eye model Scientific reports 81 (2018) 10500

Aldeyracom

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Tear Enhancements

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bull Currently approved in Japan and South Korea1

bull Main Effect Increase tear fluid and mucin secretion on the ocular surface through interaction with P2Y2 receptors in the conjunctiva

bull Evidence from clinical trials suggest diquafosol improves corneal staining more effectively than a comparable sodium hyaluronate solution2

Diquafosol Tetrasodium(3 Ophthalmic Solution)

1Koh Shizuka Clinical utility of 3 diquafosol ophthalmic solution in the treatment of dry eyes Clinical Ophthalmology (Auckland NZ) 9 (2015) 8652Takamura Etsuko et al A randomised double-masked comparison study of diquafosol versus sodium hyaluronate ophthalmic solutions in dry eye patients British Journal of Ophthalmology 9610 (2012) 1310-1315

Pubmedcom

Santencom

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Rebapimide

(2 Ophthalmic Solution)

bull Currently approved in Japanbull Main Effect stimulates mucin secretagogue activity in

cornea and conjunctivabull Clinical evidence suggests

o Statistically significant Improvement in corneal and conjunctival staining as well as in quality of life as well as in tear break-up time12

o Potential role in suppressing the expression of inflammatory proteins (Polyl)3

1 Kinoshita Shigeru et al Rebamipide (OPC-12759) in the treatment of dry eye a randomized double-masked multicenter placebo-controlled phase II study Ophthalmology11912 (2012) 2471-24782 Kashima Tomoyuki et al Rebamipide ophthalmic suspension for the treatment of dry eye syndrome a critical appraisal Clinical ophthalmology (Auckland NZ) 8 (2014) 10033Ueta Mayumi et al Rebamipide suppresses PolyI C-stimulated cytokine production in human conjunctival epithelial cells Journal of Ocular Pharmacology and Therapeutics 297 (2013) 688-693

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TrueTearreg Allerganbull FDA Clearancebull Main effect intranasal applicator sends

electrical currents to nerves that stimulate tear production

bull Evidence of improved Schirmer scores decreased symptoms and corneal and conjunctival staining at 6 mo Ocular comfort lasted for 3 hours following neurostimulationo Secondary effect intranasal application

promotes goblet cell mucin secretion which stabilizes the tear film1

Truetearcom

1Gumus K Schuetzle KL Pflugfelder SC Randomized controlled crossover trial comparing the impact of sham or intranasal tear neurostimulation on 654 GD Novack et al The Ocular Surface xxx (2017) 635e655 conjunctival goblet cell degranulation Am J Ophthalmol 2017177159e68

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Pharmaceutical to stimulate nerves

bullNasal Spray OC-01

bullOyster Point Pharma

bullStimulate natural tears

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Amniotic cytokine extract(Ocular Science)bullACE is a novel drop marketed as Genesis bullContains various cytokines growth factor

and anti-inflammatory moleculesbull Effective in a small pilot study

Amniotic Cytokine Extract Promising in Patients with Dry Ey Disease MDLinx

httpswwwmdlinxcomophthalmologyarticle1280 1113088 Accessed Jan 27 2018

Amniotic Cytokine Extract Promising in Patients with Dry Ey Disease MDLinx

httpswwwmdlinxcomophthalmologyarticle1280 1113088 Accessed Jan 27 2

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Recombinant human nerve growth factor (OxervateTM eye drops Dompeacute)

bull FDA Approval Aug 2018o First approved drug for Neurotropic keratitis (NK) ndashdegenerative disease with loss of corneal sensation o Topical eye drop o Clinical evidence of complete corneal healing in 70 of patients treated with Oxervate after 8 weeks1

1Bonini S et al Phase II Randomized Double-Masked Vehicle-Controlled Trial of Recombinant Human Nerve Growth Factor for Neurotrophic Keratitis Ophthalmology 125 1332ndash1343 (2018)

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Perfluorohexyloctane (NovaTears Novaliq)

bull Main effect prevent evaporative DED by increasing tear film and lipid layer thickness

bull Approved in Europe Australia and New Zealandbull Clinical evidence of increased tear production and tear film

stability as well as significant decrease in OSDI scores and in corneal staining1

1Steven P et al Semifluorinated Alkane Eye Drops for Treatment of Dry Eye Disease ndash A Prospective Multicenter Noninterventional Study J Ocul Pharmacol Ther 2015 Oct 1 31(8) 498-503

Corneal Epithelium Healing

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CrossThiolated Carboxymethyl Hyaluronic Acid Liquid-Gel

(Ocular Bandage Gel EyeGate Pharma)

bull Main effects accelerate corneal healing and reduce corneal stainingo Indicated for defects due to photorefcrative keratectomy (PRK)o Indicated for Punctate epitheliopathies (PE) associated with

dry eyebull Treatment in development July 2018 approval to conduct two

pilot studies using OBG for PE and PRKbull A first-in-human pilot study (n=39) showed accelerated corneal

reepithelialization through slit lamp examination at day 1 after PRK Further studies needed1

1Durrie Daniel S et al Ability of a new crosslinked polymer ocular bandage gel to accelerate reepithelialization after photorefractive keratectomy Journal of Cataract amp Refractive Surgery 443 (2018) 369-375

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Biologic MoleculesDry Eye Assessment

bull Proteoglycan-4 (Lubricin)oRecently discovered on the ocular surface in the meibomian glands2

oFunctions to prevent friction at the cornea-lid interface and has anti-inflammatory propertiesoCommercial lubricin-based lubricants remain scarceoEvidence from clinical studies with recombinant human lubricin suggest

significant improvement in signs and symptoms of DED through TBUT corneal staining and eyelid and conjunctival redness3

1De Paiva CS Chotikavanich S Pangelinan SB Pitcher 3rd JD Fang B Zheng X et al IL-17 disrupts corneal barrier following desiccating stress Mucosal Immunol 20092(3)243ndash2532Iqbal SM Leonard C Regmi SC De Rantere D Tailor P Ren G et al LubricinProteoglycan 4 binds to and regulates the activity of Toll-Like Receptors In Vitro Sci Rep20166189103Lambiase A Sullivan BD Schmidt TA Sullivan DA Jay GD Truitt ER et al A Two-Week Randomized Double-masked Study to Evaluate Safety and Efficacy of Lubricin

(150 mugmL) Eye Drops Versus Sodium Hyaluronate (HA) 018 Eye Drops (Vismed(R)) in Patients with Moderate Dry Eye Disease Ocul Surf 20171577ndash87

2018

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Why Ocular Biomarkers

Surrogate Endpoints- None accepted by the FDA or Europe to date Validation needed- clear clinical relevance

Enrichment of Study Population Still regulatory hurdles

Support mechanism of action of treatment Topical ciclosporin in Europe for Dry eyes (Europe2015 Ikervis)1

SEGMENT THE DRY EYE POPULATION- TREAT MORE SPECIFICALLY-PERSONALIZE TREATMENT

1 Ikervis SmPC June 2015 available at httpswwwmedicinesorgukemcmedicine30584

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Study Visits and Treatment Assignment

Screening

Eligibility Confirmation

Randomization

Placebo

3 Months

6 Months

12 Months

Active ω3

3 Months

6 Months

12 Months

23 13

535 Subjects

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Mean Scores of Signs Over TimeMean Change in OSDI Score Over Time

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DREAM Results

When patients who had moderate to severe dry eye disease despite use of other treatments were randomly assigned to ω3 or placebo supplements mean values for symptoms and signs improved

However we found no evidence of a beneficial effect of ω3 supplements on the symptoms and signs DED relative to placebo supplements

A therapeutic effect of 1 teaspoon of refined olive oil daily is not plausible1

1 Abell Penny A and Maureen G Maguire ldquonminus3 Fatty Acid Supplementation and Dry Eye Diseaserdquo New England Journal of Medicine vol 379 no 7 2018 pp 690ndash691

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Strengths of DREAM

bullGeneralizability ω3 added to existing treatments in patients who still had symptoms and signs despite Rx ndash REAL WORLD PATIENTSbullComparability of Groups Randomization ldquoworkedrdquobullCompliance

bull Drugs delivered to home even when missed visit

bull High rates of compliance by blood testbull Missed visit rate lt 10

bull Treatment bull Highest dose (3000 mg) of ω3 in any DED RCTbull Triglyceride ω3 form more bioavailable than ethyl esterbull Content verified by an outside laboratorybull Softgels active identical to placebobull 12 months ndash reduce seasonality effects

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New Treatment Options

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Meibomian Gland Dysfunctionbull A leading cause of Dry Eye1

bull Clinical signs of MGD2o Aberrant medium production andor composition due to Obstruction of meibomian gland (a) Gland dropout (b) Change in gland secretion (c)

bull Patients complaining of repeated lsquostyesrsquo

bull Characterized by tear film instability and rapid TFBUT1Nichols KK Foulks GN Bron AJ et al The International Workshop on Meibomian Gland Dysfunction Executive Summary

Investigative Ophthalmology amp Visual Science 201152(4)1922-19292American Academy of Ophthalmology Retina Panel Preferred Practice PatternregGuidelines Blepharitis San Francisco

CA American Academy of Ophthalmology 2008 Available at httpwwwaaoorgppp

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Meibomian Gland Dysfunction - Treatments

Heating amp Pressure Devices

bull Lipiflow

bull Intense Pulsed Light (IPL)

bull iLux

bull Blephex

bull NuLids

bull Blephasteam

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LipiFlowreg TearScience

bull FDA clearancebull Thermal pulsation Devicebull 12 minute treatmentbull Delivers heat to the inner eyelid and massage to the outside unblock the flow of lipids from the meibomian glandsbull Preliminary evidence At 3 months-1 year follow-up improved symptoms and signs (secretions TBUT)1-5

1Lane SS et al Cornea 2012 Apr31(4)396-4042Greiner JV Curr Eye Res 2012 Apr37(4)272-83Greiner JV Clin Experiment Ophthalmol 2013 Aug41(6)524-304Finis D et al Ocul Surf 2014 Apr12(2)146-545Finis D et al Cornea 2014 Dec33(12)1265-70

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Intense Pulsed Light (IPL) Lumenis or E-eyeMain effect lower eyelidsHypothesized mechanism of action1) Treat abnormal blood vessels near eyelid to close them off decrease inflammation2) Thermal treatment softens the glands and allows to discharge secretions more readilySome evidence of therapeutic potential but further studies needed1-2

1Toyos R et al Photomed Laser Surg 2015 January 1 33(1) 41ndash462Craig JP et al Invest Ophthalmol Vis Sci 2015 Feb 1256(3)1965-70 doi 101167iovs14-15764

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iLuxreg Tear Film Innovationsbull Main effect unblocks Meibomian glandsbull Heat amp pressure therapybull 8-12 min treatmentbull Handheld Devicebull Glands can be viewed via magnifier

bull No clinically significant differences between iLux and LipiFlow with respect to indication for use and device performance1

1ldquo510(K) SUMMARY ndash K172645rdquo US Food amp Drug Administration Dec 2017 wwwaccessdatafdagovcdrh_docspdf17K172645pdf

2018

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BlephExreg Rysurgbull FDA clearance bull Main effect lid margin debridement bull 6-8 minute treatmentbull In-officebull Lasts three to six months before requiring a

retreatmentbull Evidence of improvement for contact lens

wearers through significant reduction in bacterial load on patientsrsquo eyelids1

1Siddireddy JS Tan-Showyin J Vijay AK Willcox M A Comfortable Eye Needs Fats Presented at the University of New South Wales Sydney Australia 2015

Rysurgcom

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Blephasteamreg Laboratoires Theacuteabull Main effect warming goggles that promote fluidization Meibomian glands secretions through heat and pressure bull ESPOIR Study evidence of significant improvement in symptoms using the visual analogous scale (VAS)1

bull Expensive devicebull Need further studies with larger samples sizes

to determine efficacy2

1 Doan S Chiambaretta F Gabison EE Cochereau I Baudoin C Efficacy of heating wet chamber warming goggles (Blephasteamreg) in adult posterior blepharitis Invest Opthalmol Vis Sci 201152 E-Abstract 38332Benitez Del Castillo JM Kaercher T Mansour K Wylegala E Dua H Evaluation of the efficacy safety and acceptability of an eyelid warming device for the treatment of meibomian gland dysfunction Clin Ophthalmol 201482019ndash2027

2018

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NuLidstrade NuSight

bull Main effect lid scrub that stimulates Meibomian glands by removing biofilm and scurf that block the opening of the glands

bull Doctor-prescribed In-home treatmentbull 60 second daily treatmentbull A multi-center clinical study showed

evidence of 50 decrease in dry eye symptoms 65 improvement in TBUT and 81 improvement in Meibomian Gland liquid secretions1

1Schanzlin Olkowski Coble Gross NuLids II Study April 2018

2018

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TearCare System Sight Sciences

bull First wearable therapeutic eyelid therapy devicebull In-office treatmentbull 12 minute thermal eyelid treatment followed by expression forceps to

manually evacuate residual obstructionsbull Evidence from pilot study suggested improved TBUT corneal and

conjunctival staining scored and dry eye symptoms based on OSDI SPEED and SANDE1

bull Further clinical evidence underway

Badawi David A novel system TearCarereg for the treatment of the signs and symptoms of dry eye disease Clinical Ophthalmology (Auckland NZ) 12 (2018) 683

2018

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Anti-Inflammatory Pharmaceuticals

Cyclosporine

Main effectbull Anti-inflammatory therapy

bull Inhibits T-cell maturation

bull Decreases pro-inflammatory cytokines

bull Upregulates anti-inflammatory cytokines20

18 copy

48th

Europ

ean C

ontac

t Len

s Soc

iety O

f Oph

thalm

ologis

ts A

ll righ

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serve

d - A

ny re

prod

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n eve

n in p

art is

proh

ibited

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Cyclosporine A cationic emulsion 01 (Ikervisreg Santen)

bull Approved in Europe in 2015bull Main effect prolonged precorneal residence time and improved

bioavailabilityo Indicated for patients with severe DED that has not improved

using tear substitutesbull Clinical evidence of reduced HLA-DR expression at 6 mo measured

through impression cytology overall greater benefits for patients with Sjoumlgrenrsquos Syndrome1

1Leonardi A Messmer EM Labetoulle M et al Efficacy and safety of 01 ciclosporin A cationic emulsion in dry eye disease a pooled analysis of two double-masked randomised vehicle-controlled phase III clinical studies Br J Ophthalmol 2018

2018

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Cyclosporine 009 (OTX-101 CequaTM Sun Pharma)

bull FDA Approval Aug 2018

bull Highest FDA-approved concentration of cyclosporine A1

bull Main effect Increase tear production

bull Calcineurin inhibitor

bull Nanomicellar formulation eases entry into corneal and conjunctival cells

bull Two multicenter studies report a statistically significant increase (ge 10 mm) in Schirmer wetting at 3 mo in patients receiving CequaTM vs vehicle1

Cyclosporine - New Preparations

Biospacecom

1epgonlineorg ldquoFDA Approves CEQUA to Treat Dry Eye Syndrome- Sun Pharma + Sun Ophthalmicsrdquo Epgonlineorg Aug 2018 wwwepgonlineorgusnewsfda-approves-cequa-to-treat-dry-eye-syndrome---sun-pharma---sun--ophthalmics-html

2018

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Cyclosporine 005 and 01 (CyclASol Novaliq)

bull Semifluorinated alkanes formulation better dissolves Cyclosporine Abull Greater penetration than FDA-approved 005 Cyclosporine A

(Restasis)bull Evidence of decreased corneal and conjunctival staining after 14

days2

bull It remains unknown whether greater concentration leads to better results phase 3 studies are underway3

2Novaliq CyclASolreg ndash Cyclosporine in SFA for Ophthalmological Application to Treat Dry Eye Syndrome 20153 Lallemand F Shmitt M Bourges JL et al Cyclosporine A delivery to the eye a comprehensive review of academic and industrial efforts Eur J Pharm Biopharm 201711714-28

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Cyclosporin with chondroiton sulphate

Klarity- C

Imprimis- compounded

chondroitin sulfate

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SkQ1 bull Main effects synthesized small molecule targeted to reduce oxidative stress in cellmitochondria

o Regenerates itself o SkQ1 ophthalmic solution is indicated for pathologies of the eye associated with

oxidative stress such as dry eye 1

o Approved in Russia (2011) and marketed as Visomitinbull Clinical evidence suggest statistically significant 2

o Decrease in corneal stainingo Improvements in lid margin rednesso Improvements in symptoms measuredo through Ora CalibraTM scales

1Wakamatsu TH Dogru M Tsubota K Tearful relations oxidative stress inflammation and eye diseases Arq Bras Oftalmol 200871(6 Suppl)72ndash92Petrov Anton et al SkQ1 ophthalmic solution for dry eye treatment results of a phase 2 safety and efficacy clinical study in the environment and during challenge in the controlled adverse environment model Advances in therapy 331 (2016) 96-115

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Steroids- new formulation bullKPI-121- Kala Pharmaceuticals

bullMucous ndash penetrating particle ( MPP) ndashbullnano particles

bullLoteprednol -025

bull Better penetration low dose steroid

bullEpisodic flare ups of DED

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ADX-102 (Reproxalap Aldeyra Therapeutics)bull Small molecule topical agentbull Traps aldehydes that usually activate inflammatory factorsbull Positive clinical evidence of improvement in signs and

symptoms of dry eye1

Thymosin beta 4 (Tβ4 ) bull 43-amino acid G-actin binding proteinbull Downregulates transcription of inflammatory mediators and promotes corneal

epithelial cell migrationbull Phase 3 clinical trial with Tβ4 (RGN-259 RegeneRx) showed improvement in signs

and symptoms of dry eye through corneal staining tear production and expression of inflammatory factors2

1Aldehyde trap drug rapidly improves signs symptoms of dry eye disease American Academy of Ophthalmology (2017) httpswwwaaoorgheadlinealdehyde-trap-drug-rapidly-improves-signs-symptoms2Kim Chae Eun et al RGN-259 (thymosin β4) improves clinically important dry eye efficacies in comparison with prescription drugs in a dry eye model Scientific reports 81 (2018) 10500

Aldeyracom

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Tear Enhancements

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bull Currently approved in Japan and South Korea1

bull Main Effect Increase tear fluid and mucin secretion on the ocular surface through interaction with P2Y2 receptors in the conjunctiva

bull Evidence from clinical trials suggest diquafosol improves corneal staining more effectively than a comparable sodium hyaluronate solution2

Diquafosol Tetrasodium(3 Ophthalmic Solution)

1Koh Shizuka Clinical utility of 3 diquafosol ophthalmic solution in the treatment of dry eyes Clinical Ophthalmology (Auckland NZ) 9 (2015) 8652Takamura Etsuko et al A randomised double-masked comparison study of diquafosol versus sodium hyaluronate ophthalmic solutions in dry eye patients British Journal of Ophthalmology 9610 (2012) 1310-1315

Pubmedcom

Santencom

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Rebapimide

(2 Ophthalmic Solution)

bull Currently approved in Japanbull Main Effect stimulates mucin secretagogue activity in

cornea and conjunctivabull Clinical evidence suggests

o Statistically significant Improvement in corneal and conjunctival staining as well as in quality of life as well as in tear break-up time12

o Potential role in suppressing the expression of inflammatory proteins (Polyl)3

1 Kinoshita Shigeru et al Rebamipide (OPC-12759) in the treatment of dry eye a randomized double-masked multicenter placebo-controlled phase II study Ophthalmology11912 (2012) 2471-24782 Kashima Tomoyuki et al Rebamipide ophthalmic suspension for the treatment of dry eye syndrome a critical appraisal Clinical ophthalmology (Auckland NZ) 8 (2014) 10033Ueta Mayumi et al Rebamipide suppresses PolyI C-stimulated cytokine production in human conjunctival epithelial cells Journal of Ocular Pharmacology and Therapeutics 297 (2013) 688-693

2018

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TrueTearreg Allerganbull FDA Clearancebull Main effect intranasal applicator sends

electrical currents to nerves that stimulate tear production

bull Evidence of improved Schirmer scores decreased symptoms and corneal and conjunctival staining at 6 mo Ocular comfort lasted for 3 hours following neurostimulationo Secondary effect intranasal application

promotes goblet cell mucin secretion which stabilizes the tear film1

Truetearcom

1Gumus K Schuetzle KL Pflugfelder SC Randomized controlled crossover trial comparing the impact of sham or intranasal tear neurostimulation on 654 GD Novack et al The Ocular Surface xxx (2017) 635e655 conjunctival goblet cell degranulation Am J Ophthalmol 2017177159e68

2018

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Pharmaceutical to stimulate nerves

bullNasal Spray OC-01

bullOyster Point Pharma

bullStimulate natural tears

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Amniotic cytokine extract(Ocular Science)bullACE is a novel drop marketed as Genesis bullContains various cytokines growth factor

and anti-inflammatory moleculesbull Effective in a small pilot study

Amniotic Cytokine Extract Promising in Patients with Dry Ey Disease MDLinx

httpswwwmdlinxcomophthalmologyarticle1280 1113088 Accessed Jan 27 2018

Amniotic Cytokine Extract Promising in Patients with Dry Ey Disease MDLinx

httpswwwmdlinxcomophthalmologyarticle1280 1113088 Accessed Jan 27 2

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Recombinant human nerve growth factor (OxervateTM eye drops Dompeacute)

bull FDA Approval Aug 2018o First approved drug for Neurotropic keratitis (NK) ndashdegenerative disease with loss of corneal sensation o Topical eye drop o Clinical evidence of complete corneal healing in 70 of patients treated with Oxervate after 8 weeks1

1Bonini S et al Phase II Randomized Double-Masked Vehicle-Controlled Trial of Recombinant Human Nerve Growth Factor for Neurotrophic Keratitis Ophthalmology 125 1332ndash1343 (2018)

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Perfluorohexyloctane (NovaTears Novaliq)

bull Main effect prevent evaporative DED by increasing tear film and lipid layer thickness

bull Approved in Europe Australia and New Zealandbull Clinical evidence of increased tear production and tear film

stability as well as significant decrease in OSDI scores and in corneal staining1

1Steven P et al Semifluorinated Alkane Eye Drops for Treatment of Dry Eye Disease ndash A Prospective Multicenter Noninterventional Study J Ocul Pharmacol Ther 2015 Oct 1 31(8) 498-503

Corneal Epithelium Healing

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CrossThiolated Carboxymethyl Hyaluronic Acid Liquid-Gel

(Ocular Bandage Gel EyeGate Pharma)

bull Main effects accelerate corneal healing and reduce corneal stainingo Indicated for defects due to photorefcrative keratectomy (PRK)o Indicated for Punctate epitheliopathies (PE) associated with

dry eyebull Treatment in development July 2018 approval to conduct two

pilot studies using OBG for PE and PRKbull A first-in-human pilot study (n=39) showed accelerated corneal

reepithelialization through slit lamp examination at day 1 after PRK Further studies needed1

1Durrie Daniel S et al Ability of a new crosslinked polymer ocular bandage gel to accelerate reepithelialization after photorefractive keratectomy Journal of Cataract amp Refractive Surgery 443 (2018) 369-375

2018

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Biologic MoleculesDry Eye Assessment

bull Proteoglycan-4 (Lubricin)oRecently discovered on the ocular surface in the meibomian glands2

oFunctions to prevent friction at the cornea-lid interface and has anti-inflammatory propertiesoCommercial lubricin-based lubricants remain scarceoEvidence from clinical studies with recombinant human lubricin suggest

significant improvement in signs and symptoms of DED through TBUT corneal staining and eyelid and conjunctival redness3

1De Paiva CS Chotikavanich S Pangelinan SB Pitcher 3rd JD Fang B Zheng X et al IL-17 disrupts corneal barrier following desiccating stress Mucosal Immunol 20092(3)243ndash2532Iqbal SM Leonard C Regmi SC De Rantere D Tailor P Ren G et al LubricinProteoglycan 4 binds to and regulates the activity of Toll-Like Receptors In Vitro Sci Rep20166189103Lambiase A Sullivan BD Schmidt TA Sullivan DA Jay GD Truitt ER et al A Two-Week Randomized Double-masked Study to Evaluate Safety and Efficacy of Lubricin

(150 mugmL) Eye Drops Versus Sodium Hyaluronate (HA) 018 Eye Drops (Vismed(R)) in Patients with Moderate Dry Eye Disease Ocul Surf 20171577ndash87

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Why Ocular Biomarkers

Surrogate Endpoints- None accepted by the FDA or Europe to date Validation needed- clear clinical relevance

Enrichment of Study Population Still regulatory hurdles

Support mechanism of action of treatment Topical ciclosporin in Europe for Dry eyes (Europe2015 Ikervis)1

SEGMENT THE DRY EYE POPULATION- TREAT MORE SPECIFICALLY-PERSONALIZE TREATMENT

1 Ikervis SmPC June 2015 available at httpswwwmedicinesorgukemcmedicine30584

2018

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Mean Scores of Signs Over TimeMean Change in OSDI Score Over Time

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DREAM Results

When patients who had moderate to severe dry eye disease despite use of other treatments were randomly assigned to ω3 or placebo supplements mean values for symptoms and signs improved

However we found no evidence of a beneficial effect of ω3 supplements on the symptoms and signs DED relative to placebo supplements

A therapeutic effect of 1 teaspoon of refined olive oil daily is not plausible1

1 Abell Penny A and Maureen G Maguire ldquonminus3 Fatty Acid Supplementation and Dry Eye Diseaserdquo New England Journal of Medicine vol 379 no 7 2018 pp 690ndash691

2018

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Strengths of DREAM

bullGeneralizability ω3 added to existing treatments in patients who still had symptoms and signs despite Rx ndash REAL WORLD PATIENTSbullComparability of Groups Randomization ldquoworkedrdquobullCompliance

bull Drugs delivered to home even when missed visit

bull High rates of compliance by blood testbull Missed visit rate lt 10

bull Treatment bull Highest dose (3000 mg) of ω3 in any DED RCTbull Triglyceride ω3 form more bioavailable than ethyl esterbull Content verified by an outside laboratorybull Softgels active identical to placebobull 12 months ndash reduce seasonality effects

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New Treatment Options

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Meibomian Gland Dysfunctionbull A leading cause of Dry Eye1

bull Clinical signs of MGD2o Aberrant medium production andor composition due to Obstruction of meibomian gland (a) Gland dropout (b) Change in gland secretion (c)

bull Patients complaining of repeated lsquostyesrsquo

bull Characterized by tear film instability and rapid TFBUT1Nichols KK Foulks GN Bron AJ et al The International Workshop on Meibomian Gland Dysfunction Executive Summary

Investigative Ophthalmology amp Visual Science 201152(4)1922-19292American Academy of Ophthalmology Retina Panel Preferred Practice PatternregGuidelines Blepharitis San Francisco

CA American Academy of Ophthalmology 2008 Available at httpwwwaaoorgppp

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Meibomian Gland Dysfunction - Treatments

Heating amp Pressure Devices

bull Lipiflow

bull Intense Pulsed Light (IPL)

bull iLux

bull Blephex

bull NuLids

bull Blephasteam

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LipiFlowreg TearScience

bull FDA clearancebull Thermal pulsation Devicebull 12 minute treatmentbull Delivers heat to the inner eyelid and massage to the outside unblock the flow of lipids from the meibomian glandsbull Preliminary evidence At 3 months-1 year follow-up improved symptoms and signs (secretions TBUT)1-5

1Lane SS et al Cornea 2012 Apr31(4)396-4042Greiner JV Curr Eye Res 2012 Apr37(4)272-83Greiner JV Clin Experiment Ophthalmol 2013 Aug41(6)524-304Finis D et al Ocul Surf 2014 Apr12(2)146-545Finis D et al Cornea 2014 Dec33(12)1265-70

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Intense Pulsed Light (IPL) Lumenis or E-eyeMain effect lower eyelidsHypothesized mechanism of action1) Treat abnormal blood vessels near eyelid to close them off decrease inflammation2) Thermal treatment softens the glands and allows to discharge secretions more readilySome evidence of therapeutic potential but further studies needed1-2

1Toyos R et al Photomed Laser Surg 2015 January 1 33(1) 41ndash462Craig JP et al Invest Ophthalmol Vis Sci 2015 Feb 1256(3)1965-70 doi 101167iovs14-15764

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iLuxreg Tear Film Innovationsbull Main effect unblocks Meibomian glandsbull Heat amp pressure therapybull 8-12 min treatmentbull Handheld Devicebull Glands can be viewed via magnifier

bull No clinically significant differences between iLux and LipiFlow with respect to indication for use and device performance1

1ldquo510(K) SUMMARY ndash K172645rdquo US Food amp Drug Administration Dec 2017 wwwaccessdatafdagovcdrh_docspdf17K172645pdf

2018

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BlephExreg Rysurgbull FDA clearance bull Main effect lid margin debridement bull 6-8 minute treatmentbull In-officebull Lasts three to six months before requiring a

retreatmentbull Evidence of improvement for contact lens

wearers through significant reduction in bacterial load on patientsrsquo eyelids1

1Siddireddy JS Tan-Showyin J Vijay AK Willcox M A Comfortable Eye Needs Fats Presented at the University of New South Wales Sydney Australia 2015

Rysurgcom

2018

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Blephasteamreg Laboratoires Theacuteabull Main effect warming goggles that promote fluidization Meibomian glands secretions through heat and pressure bull ESPOIR Study evidence of significant improvement in symptoms using the visual analogous scale (VAS)1

bull Expensive devicebull Need further studies with larger samples sizes

to determine efficacy2

1 Doan S Chiambaretta F Gabison EE Cochereau I Baudoin C Efficacy of heating wet chamber warming goggles (Blephasteamreg) in adult posterior blepharitis Invest Opthalmol Vis Sci 201152 E-Abstract 38332Benitez Del Castillo JM Kaercher T Mansour K Wylegala E Dua H Evaluation of the efficacy safety and acceptability of an eyelid warming device for the treatment of meibomian gland dysfunction Clin Ophthalmol 201482019ndash2027

2018

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NuLidstrade NuSight

bull Main effect lid scrub that stimulates Meibomian glands by removing biofilm and scurf that block the opening of the glands

bull Doctor-prescribed In-home treatmentbull 60 second daily treatmentbull A multi-center clinical study showed

evidence of 50 decrease in dry eye symptoms 65 improvement in TBUT and 81 improvement in Meibomian Gland liquid secretions1

1Schanzlin Olkowski Coble Gross NuLids II Study April 2018

2018

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TearCare System Sight Sciences

bull First wearable therapeutic eyelid therapy devicebull In-office treatmentbull 12 minute thermal eyelid treatment followed by expression forceps to

manually evacuate residual obstructionsbull Evidence from pilot study suggested improved TBUT corneal and

conjunctival staining scored and dry eye symptoms based on OSDI SPEED and SANDE1

bull Further clinical evidence underway

Badawi David A novel system TearCarereg for the treatment of the signs and symptoms of dry eye disease Clinical Ophthalmology (Auckland NZ) 12 (2018) 683

2018

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Anti-Inflammatory Pharmaceuticals

Cyclosporine

Main effectbull Anti-inflammatory therapy

bull Inhibits T-cell maturation

bull Decreases pro-inflammatory cytokines

bull Upregulates anti-inflammatory cytokines20

18 copy

48th

Europ

ean C

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s Soc

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f Oph

thalm

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ny re

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Cyclosporine A cationic emulsion 01 (Ikervisreg Santen)

bull Approved in Europe in 2015bull Main effect prolonged precorneal residence time and improved

bioavailabilityo Indicated for patients with severe DED that has not improved

using tear substitutesbull Clinical evidence of reduced HLA-DR expression at 6 mo measured

through impression cytology overall greater benefits for patients with Sjoumlgrenrsquos Syndrome1

1Leonardi A Messmer EM Labetoulle M et al Efficacy and safety of 01 ciclosporin A cationic emulsion in dry eye disease a pooled analysis of two double-masked randomised vehicle-controlled phase III clinical studies Br J Ophthalmol 2018

2018

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Cyclosporine 009 (OTX-101 CequaTM Sun Pharma)

bull FDA Approval Aug 2018

bull Highest FDA-approved concentration of cyclosporine A1

bull Main effect Increase tear production

bull Calcineurin inhibitor

bull Nanomicellar formulation eases entry into corneal and conjunctival cells

bull Two multicenter studies report a statistically significant increase (ge 10 mm) in Schirmer wetting at 3 mo in patients receiving CequaTM vs vehicle1

Cyclosporine - New Preparations

Biospacecom

1epgonlineorg ldquoFDA Approves CEQUA to Treat Dry Eye Syndrome- Sun Pharma + Sun Ophthalmicsrdquo Epgonlineorg Aug 2018 wwwepgonlineorgusnewsfda-approves-cequa-to-treat-dry-eye-syndrome---sun-pharma---sun--ophthalmics-html

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Cyclosporine 005 and 01 (CyclASol Novaliq)

bull Semifluorinated alkanes formulation better dissolves Cyclosporine Abull Greater penetration than FDA-approved 005 Cyclosporine A

(Restasis)bull Evidence of decreased corneal and conjunctival staining after 14

days2

bull It remains unknown whether greater concentration leads to better results phase 3 studies are underway3

2Novaliq CyclASolreg ndash Cyclosporine in SFA for Ophthalmological Application to Treat Dry Eye Syndrome 20153 Lallemand F Shmitt M Bourges JL et al Cyclosporine A delivery to the eye a comprehensive review of academic and industrial efforts Eur J Pharm Biopharm 201711714-28

2018

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Cyclosporin with chondroiton sulphate

Klarity- C

Imprimis- compounded

chondroitin sulfate

2018

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SkQ1 bull Main effects synthesized small molecule targeted to reduce oxidative stress in cellmitochondria

o Regenerates itself o SkQ1 ophthalmic solution is indicated for pathologies of the eye associated with

oxidative stress such as dry eye 1

o Approved in Russia (2011) and marketed as Visomitinbull Clinical evidence suggest statistically significant 2

o Decrease in corneal stainingo Improvements in lid margin rednesso Improvements in symptoms measuredo through Ora CalibraTM scales

1Wakamatsu TH Dogru M Tsubota K Tearful relations oxidative stress inflammation and eye diseases Arq Bras Oftalmol 200871(6 Suppl)72ndash92Petrov Anton et al SkQ1 ophthalmic solution for dry eye treatment results of a phase 2 safety and efficacy clinical study in the environment and during challenge in the controlled adverse environment model Advances in therapy 331 (2016) 96-115

2018

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Steroids- new formulation bullKPI-121- Kala Pharmaceuticals

bullMucous ndash penetrating particle ( MPP) ndashbullnano particles

bullLoteprednol -025

bull Better penetration low dose steroid

bullEpisodic flare ups of DED

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ADX-102 (Reproxalap Aldeyra Therapeutics)bull Small molecule topical agentbull Traps aldehydes that usually activate inflammatory factorsbull Positive clinical evidence of improvement in signs and

symptoms of dry eye1

Thymosin beta 4 (Tβ4 ) bull 43-amino acid G-actin binding proteinbull Downregulates transcription of inflammatory mediators and promotes corneal

epithelial cell migrationbull Phase 3 clinical trial with Tβ4 (RGN-259 RegeneRx) showed improvement in signs

and symptoms of dry eye through corneal staining tear production and expression of inflammatory factors2

1Aldehyde trap drug rapidly improves signs symptoms of dry eye disease American Academy of Ophthalmology (2017) httpswwwaaoorgheadlinealdehyde-trap-drug-rapidly-improves-signs-symptoms2Kim Chae Eun et al RGN-259 (thymosin β4) improves clinically important dry eye efficacies in comparison with prescription drugs in a dry eye model Scientific reports 81 (2018) 10500

Aldeyracom

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Tear Enhancements

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bull Currently approved in Japan and South Korea1

bull Main Effect Increase tear fluid and mucin secretion on the ocular surface through interaction with P2Y2 receptors in the conjunctiva

bull Evidence from clinical trials suggest diquafosol improves corneal staining more effectively than a comparable sodium hyaluronate solution2

Diquafosol Tetrasodium(3 Ophthalmic Solution)

1Koh Shizuka Clinical utility of 3 diquafosol ophthalmic solution in the treatment of dry eyes Clinical Ophthalmology (Auckland NZ) 9 (2015) 8652Takamura Etsuko et al A randomised double-masked comparison study of diquafosol versus sodium hyaluronate ophthalmic solutions in dry eye patients British Journal of Ophthalmology 9610 (2012) 1310-1315

Pubmedcom

Santencom

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Rebapimide

(2 Ophthalmic Solution)

bull Currently approved in Japanbull Main Effect stimulates mucin secretagogue activity in

cornea and conjunctivabull Clinical evidence suggests

o Statistically significant Improvement in corneal and conjunctival staining as well as in quality of life as well as in tear break-up time12

o Potential role in suppressing the expression of inflammatory proteins (Polyl)3

1 Kinoshita Shigeru et al Rebamipide (OPC-12759) in the treatment of dry eye a randomized double-masked multicenter placebo-controlled phase II study Ophthalmology11912 (2012) 2471-24782 Kashima Tomoyuki et al Rebamipide ophthalmic suspension for the treatment of dry eye syndrome a critical appraisal Clinical ophthalmology (Auckland NZ) 8 (2014) 10033Ueta Mayumi et al Rebamipide suppresses PolyI C-stimulated cytokine production in human conjunctival epithelial cells Journal of Ocular Pharmacology and Therapeutics 297 (2013) 688-693

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TrueTearreg Allerganbull FDA Clearancebull Main effect intranasal applicator sends

electrical currents to nerves that stimulate tear production

bull Evidence of improved Schirmer scores decreased symptoms and corneal and conjunctival staining at 6 mo Ocular comfort lasted for 3 hours following neurostimulationo Secondary effect intranasal application

promotes goblet cell mucin secretion which stabilizes the tear film1

Truetearcom

1Gumus K Schuetzle KL Pflugfelder SC Randomized controlled crossover trial comparing the impact of sham or intranasal tear neurostimulation on 654 GD Novack et al The Ocular Surface xxx (2017) 635e655 conjunctival goblet cell degranulation Am J Ophthalmol 2017177159e68

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Pharmaceutical to stimulate nerves

bullNasal Spray OC-01

bullOyster Point Pharma

bullStimulate natural tears

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Amniotic cytokine extract(Ocular Science)bullACE is a novel drop marketed as Genesis bullContains various cytokines growth factor

and anti-inflammatory moleculesbull Effective in a small pilot study

Amniotic Cytokine Extract Promising in Patients with Dry Ey Disease MDLinx

httpswwwmdlinxcomophthalmologyarticle1280 1113088 Accessed Jan 27 2018

Amniotic Cytokine Extract Promising in Patients with Dry Ey Disease MDLinx

httpswwwmdlinxcomophthalmologyarticle1280 1113088 Accessed Jan 27 2

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Recombinant human nerve growth factor (OxervateTM eye drops Dompeacute)

bull FDA Approval Aug 2018o First approved drug for Neurotropic keratitis (NK) ndashdegenerative disease with loss of corneal sensation o Topical eye drop o Clinical evidence of complete corneal healing in 70 of patients treated with Oxervate after 8 weeks1

1Bonini S et al Phase II Randomized Double-Masked Vehicle-Controlled Trial of Recombinant Human Nerve Growth Factor for Neurotrophic Keratitis Ophthalmology 125 1332ndash1343 (2018)

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Perfluorohexyloctane (NovaTears Novaliq)

bull Main effect prevent evaporative DED by increasing tear film and lipid layer thickness

bull Approved in Europe Australia and New Zealandbull Clinical evidence of increased tear production and tear film

stability as well as significant decrease in OSDI scores and in corneal staining1

1Steven P et al Semifluorinated Alkane Eye Drops for Treatment of Dry Eye Disease ndash A Prospective Multicenter Noninterventional Study J Ocul Pharmacol Ther 2015 Oct 1 31(8) 498-503

Corneal Epithelium Healing

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CrossThiolated Carboxymethyl Hyaluronic Acid Liquid-Gel

(Ocular Bandage Gel EyeGate Pharma)

bull Main effects accelerate corneal healing and reduce corneal stainingo Indicated for defects due to photorefcrative keratectomy (PRK)o Indicated for Punctate epitheliopathies (PE) associated with

dry eyebull Treatment in development July 2018 approval to conduct two

pilot studies using OBG for PE and PRKbull A first-in-human pilot study (n=39) showed accelerated corneal

reepithelialization through slit lamp examination at day 1 after PRK Further studies needed1

1Durrie Daniel S et al Ability of a new crosslinked polymer ocular bandage gel to accelerate reepithelialization after photorefractive keratectomy Journal of Cataract amp Refractive Surgery 443 (2018) 369-375

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Biologic MoleculesDry Eye Assessment

bull Proteoglycan-4 (Lubricin)oRecently discovered on the ocular surface in the meibomian glands2

oFunctions to prevent friction at the cornea-lid interface and has anti-inflammatory propertiesoCommercial lubricin-based lubricants remain scarceoEvidence from clinical studies with recombinant human lubricin suggest

significant improvement in signs and symptoms of DED through TBUT corneal staining and eyelid and conjunctival redness3

1De Paiva CS Chotikavanich S Pangelinan SB Pitcher 3rd JD Fang B Zheng X et al IL-17 disrupts corneal barrier following desiccating stress Mucosal Immunol 20092(3)243ndash2532Iqbal SM Leonard C Regmi SC De Rantere D Tailor P Ren G et al LubricinProteoglycan 4 binds to and regulates the activity of Toll-Like Receptors In Vitro Sci Rep20166189103Lambiase A Sullivan BD Schmidt TA Sullivan DA Jay GD Truitt ER et al A Two-Week Randomized Double-masked Study to Evaluate Safety and Efficacy of Lubricin

(150 mugmL) Eye Drops Versus Sodium Hyaluronate (HA) 018 Eye Drops (Vismed(R)) in Patients with Moderate Dry Eye Disease Ocul Surf 20171577ndash87

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Why Ocular Biomarkers

Surrogate Endpoints- None accepted by the FDA or Europe to date Validation needed- clear clinical relevance

Enrichment of Study Population Still regulatory hurdles

Support mechanism of action of treatment Topical ciclosporin in Europe for Dry eyes (Europe2015 Ikervis)1

SEGMENT THE DRY EYE POPULATION- TREAT MORE SPECIFICALLY-PERSONALIZE TREATMENT

1 Ikervis SmPC June 2015 available at httpswwwmedicinesorgukemcmedicine30584

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DREAM Results

When patients who had moderate to severe dry eye disease despite use of other treatments were randomly assigned to ω3 or placebo supplements mean values for symptoms and signs improved

However we found no evidence of a beneficial effect of ω3 supplements on the symptoms and signs DED relative to placebo supplements

A therapeutic effect of 1 teaspoon of refined olive oil daily is not plausible1

1 Abell Penny A and Maureen G Maguire ldquonminus3 Fatty Acid Supplementation and Dry Eye Diseaserdquo New England Journal of Medicine vol 379 no 7 2018 pp 690ndash691

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Strengths of DREAM

bullGeneralizability ω3 added to existing treatments in patients who still had symptoms and signs despite Rx ndash REAL WORLD PATIENTSbullComparability of Groups Randomization ldquoworkedrdquobullCompliance

bull Drugs delivered to home even when missed visit

bull High rates of compliance by blood testbull Missed visit rate lt 10

bull Treatment bull Highest dose (3000 mg) of ω3 in any DED RCTbull Triglyceride ω3 form more bioavailable than ethyl esterbull Content verified by an outside laboratorybull Softgels active identical to placebobull 12 months ndash reduce seasonality effects

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New Treatment Options

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Meibomian Gland Dysfunctionbull A leading cause of Dry Eye1

bull Clinical signs of MGD2o Aberrant medium production andor composition due to Obstruction of meibomian gland (a) Gland dropout (b) Change in gland secretion (c)

bull Patients complaining of repeated lsquostyesrsquo

bull Characterized by tear film instability and rapid TFBUT1Nichols KK Foulks GN Bron AJ et al The International Workshop on Meibomian Gland Dysfunction Executive Summary

Investigative Ophthalmology amp Visual Science 201152(4)1922-19292American Academy of Ophthalmology Retina Panel Preferred Practice PatternregGuidelines Blepharitis San Francisco

CA American Academy of Ophthalmology 2008 Available at httpwwwaaoorgppp

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Meibomian Gland Dysfunction - Treatments

Heating amp Pressure Devices

bull Lipiflow

bull Intense Pulsed Light (IPL)

bull iLux

bull Blephex

bull NuLids

bull Blephasteam

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LipiFlowreg TearScience

bull FDA clearancebull Thermal pulsation Devicebull 12 minute treatmentbull Delivers heat to the inner eyelid and massage to the outside unblock the flow of lipids from the meibomian glandsbull Preliminary evidence At 3 months-1 year follow-up improved symptoms and signs (secretions TBUT)1-5

1Lane SS et al Cornea 2012 Apr31(4)396-4042Greiner JV Curr Eye Res 2012 Apr37(4)272-83Greiner JV Clin Experiment Ophthalmol 2013 Aug41(6)524-304Finis D et al Ocul Surf 2014 Apr12(2)146-545Finis D et al Cornea 2014 Dec33(12)1265-70

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Intense Pulsed Light (IPL) Lumenis or E-eyeMain effect lower eyelidsHypothesized mechanism of action1) Treat abnormal blood vessels near eyelid to close them off decrease inflammation2) Thermal treatment softens the glands and allows to discharge secretions more readilySome evidence of therapeutic potential but further studies needed1-2

1Toyos R et al Photomed Laser Surg 2015 January 1 33(1) 41ndash462Craig JP et al Invest Ophthalmol Vis Sci 2015 Feb 1256(3)1965-70 doi 101167iovs14-15764

2018

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iLuxreg Tear Film Innovationsbull Main effect unblocks Meibomian glandsbull Heat amp pressure therapybull 8-12 min treatmentbull Handheld Devicebull Glands can be viewed via magnifier

bull No clinically significant differences between iLux and LipiFlow with respect to indication for use and device performance1

1ldquo510(K) SUMMARY ndash K172645rdquo US Food amp Drug Administration Dec 2017 wwwaccessdatafdagovcdrh_docspdf17K172645pdf

2018

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BlephExreg Rysurgbull FDA clearance bull Main effect lid margin debridement bull 6-8 minute treatmentbull In-officebull Lasts three to six months before requiring a

retreatmentbull Evidence of improvement for contact lens

wearers through significant reduction in bacterial load on patientsrsquo eyelids1

1Siddireddy JS Tan-Showyin J Vijay AK Willcox M A Comfortable Eye Needs Fats Presented at the University of New South Wales Sydney Australia 2015

Rysurgcom

2018

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Blephasteamreg Laboratoires Theacuteabull Main effect warming goggles that promote fluidization Meibomian glands secretions through heat and pressure bull ESPOIR Study evidence of significant improvement in symptoms using the visual analogous scale (VAS)1

bull Expensive devicebull Need further studies with larger samples sizes

to determine efficacy2

1 Doan S Chiambaretta F Gabison EE Cochereau I Baudoin C Efficacy of heating wet chamber warming goggles (Blephasteamreg) in adult posterior blepharitis Invest Opthalmol Vis Sci 201152 E-Abstract 38332Benitez Del Castillo JM Kaercher T Mansour K Wylegala E Dua H Evaluation of the efficacy safety and acceptability of an eyelid warming device for the treatment of meibomian gland dysfunction Clin Ophthalmol 201482019ndash2027

2018

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NuLidstrade NuSight

bull Main effect lid scrub that stimulates Meibomian glands by removing biofilm and scurf that block the opening of the glands

bull Doctor-prescribed In-home treatmentbull 60 second daily treatmentbull A multi-center clinical study showed

evidence of 50 decrease in dry eye symptoms 65 improvement in TBUT and 81 improvement in Meibomian Gland liquid secretions1

1Schanzlin Olkowski Coble Gross NuLids II Study April 2018

2018

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TearCare System Sight Sciences

bull First wearable therapeutic eyelid therapy devicebull In-office treatmentbull 12 minute thermal eyelid treatment followed by expression forceps to

manually evacuate residual obstructionsbull Evidence from pilot study suggested improved TBUT corneal and

conjunctival staining scored and dry eye symptoms based on OSDI SPEED and SANDE1

bull Further clinical evidence underway

Badawi David A novel system TearCarereg for the treatment of the signs and symptoms of dry eye disease Clinical Ophthalmology (Auckland NZ) 12 (2018) 683

2018

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Anti-Inflammatory Pharmaceuticals

Cyclosporine

Main effectbull Anti-inflammatory therapy

bull Inhibits T-cell maturation

bull Decreases pro-inflammatory cytokines

bull Upregulates anti-inflammatory cytokines20

18 copy

48th

Europ

ean C

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s Soc

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f Oph

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ny re

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proh

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Cyclosporine A cationic emulsion 01 (Ikervisreg Santen)

bull Approved in Europe in 2015bull Main effect prolonged precorneal residence time and improved

bioavailabilityo Indicated for patients with severe DED that has not improved

using tear substitutesbull Clinical evidence of reduced HLA-DR expression at 6 mo measured

through impression cytology overall greater benefits for patients with Sjoumlgrenrsquos Syndrome1

1Leonardi A Messmer EM Labetoulle M et al Efficacy and safety of 01 ciclosporin A cationic emulsion in dry eye disease a pooled analysis of two double-masked randomised vehicle-controlled phase III clinical studies Br J Ophthalmol 2018

2018

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Cyclosporine 009 (OTX-101 CequaTM Sun Pharma)

bull FDA Approval Aug 2018

bull Highest FDA-approved concentration of cyclosporine A1

bull Main effect Increase tear production

bull Calcineurin inhibitor

bull Nanomicellar formulation eases entry into corneal and conjunctival cells

bull Two multicenter studies report a statistically significant increase (ge 10 mm) in Schirmer wetting at 3 mo in patients receiving CequaTM vs vehicle1

Cyclosporine - New Preparations

Biospacecom

1epgonlineorg ldquoFDA Approves CEQUA to Treat Dry Eye Syndrome- Sun Pharma + Sun Ophthalmicsrdquo Epgonlineorg Aug 2018 wwwepgonlineorgusnewsfda-approves-cequa-to-treat-dry-eye-syndrome---sun-pharma---sun--ophthalmics-html

2018

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Cyclosporine 005 and 01 (CyclASol Novaliq)

bull Semifluorinated alkanes formulation better dissolves Cyclosporine Abull Greater penetration than FDA-approved 005 Cyclosporine A

(Restasis)bull Evidence of decreased corneal and conjunctival staining after 14

days2

bull It remains unknown whether greater concentration leads to better results phase 3 studies are underway3

2Novaliq CyclASolreg ndash Cyclosporine in SFA for Ophthalmological Application to Treat Dry Eye Syndrome 20153 Lallemand F Shmitt M Bourges JL et al Cyclosporine A delivery to the eye a comprehensive review of academic and industrial efforts Eur J Pharm Biopharm 201711714-28

2018

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Cyclosporin with chondroiton sulphate

Klarity- C

Imprimis- compounded

chondroitin sulfate

2018

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SkQ1 bull Main effects synthesized small molecule targeted to reduce oxidative stress in cellmitochondria

o Regenerates itself o SkQ1 ophthalmic solution is indicated for pathologies of the eye associated with

oxidative stress such as dry eye 1

o Approved in Russia (2011) and marketed as Visomitinbull Clinical evidence suggest statistically significant 2

o Decrease in corneal stainingo Improvements in lid margin rednesso Improvements in symptoms measuredo through Ora CalibraTM scales

1Wakamatsu TH Dogru M Tsubota K Tearful relations oxidative stress inflammation and eye diseases Arq Bras Oftalmol 200871(6 Suppl)72ndash92Petrov Anton et al SkQ1 ophthalmic solution for dry eye treatment results of a phase 2 safety and efficacy clinical study in the environment and during challenge in the controlled adverse environment model Advances in therapy 331 (2016) 96-115

2018

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Steroids- new formulation bullKPI-121- Kala Pharmaceuticals

bullMucous ndash penetrating particle ( MPP) ndashbullnano particles

bullLoteprednol -025

bull Better penetration low dose steroid

bullEpisodic flare ups of DED

2018

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ADX-102 (Reproxalap Aldeyra Therapeutics)bull Small molecule topical agentbull Traps aldehydes that usually activate inflammatory factorsbull Positive clinical evidence of improvement in signs and

symptoms of dry eye1

Thymosin beta 4 (Tβ4 ) bull 43-amino acid G-actin binding proteinbull Downregulates transcription of inflammatory mediators and promotes corneal

epithelial cell migrationbull Phase 3 clinical trial with Tβ4 (RGN-259 RegeneRx) showed improvement in signs

and symptoms of dry eye through corneal staining tear production and expression of inflammatory factors2

1Aldehyde trap drug rapidly improves signs symptoms of dry eye disease American Academy of Ophthalmology (2017) httpswwwaaoorgheadlinealdehyde-trap-drug-rapidly-improves-signs-symptoms2Kim Chae Eun et al RGN-259 (thymosin β4) improves clinically important dry eye efficacies in comparison with prescription drugs in a dry eye model Scientific reports 81 (2018) 10500

Aldeyracom

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Tear Enhancements

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bull Currently approved in Japan and South Korea1

bull Main Effect Increase tear fluid and mucin secretion on the ocular surface through interaction with P2Y2 receptors in the conjunctiva

bull Evidence from clinical trials suggest diquafosol improves corneal staining more effectively than a comparable sodium hyaluronate solution2

Diquafosol Tetrasodium(3 Ophthalmic Solution)

1Koh Shizuka Clinical utility of 3 diquafosol ophthalmic solution in the treatment of dry eyes Clinical Ophthalmology (Auckland NZ) 9 (2015) 8652Takamura Etsuko et al A randomised double-masked comparison study of diquafosol versus sodium hyaluronate ophthalmic solutions in dry eye patients British Journal of Ophthalmology 9610 (2012) 1310-1315

Pubmedcom

Santencom

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Rebapimide

(2 Ophthalmic Solution)

bull Currently approved in Japanbull Main Effect stimulates mucin secretagogue activity in

cornea and conjunctivabull Clinical evidence suggests

o Statistically significant Improvement in corneal and conjunctival staining as well as in quality of life as well as in tear break-up time12

o Potential role in suppressing the expression of inflammatory proteins (Polyl)3

1 Kinoshita Shigeru et al Rebamipide (OPC-12759) in the treatment of dry eye a randomized double-masked multicenter placebo-controlled phase II study Ophthalmology11912 (2012) 2471-24782 Kashima Tomoyuki et al Rebamipide ophthalmic suspension for the treatment of dry eye syndrome a critical appraisal Clinical ophthalmology (Auckland NZ) 8 (2014) 10033Ueta Mayumi et al Rebamipide suppresses PolyI C-stimulated cytokine production in human conjunctival epithelial cells Journal of Ocular Pharmacology and Therapeutics 297 (2013) 688-693

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TrueTearreg Allerganbull FDA Clearancebull Main effect intranasal applicator sends

electrical currents to nerves that stimulate tear production

bull Evidence of improved Schirmer scores decreased symptoms and corneal and conjunctival staining at 6 mo Ocular comfort lasted for 3 hours following neurostimulationo Secondary effect intranasal application

promotes goblet cell mucin secretion which stabilizes the tear film1

Truetearcom

1Gumus K Schuetzle KL Pflugfelder SC Randomized controlled crossover trial comparing the impact of sham or intranasal tear neurostimulation on 654 GD Novack et al The Ocular Surface xxx (2017) 635e655 conjunctival goblet cell degranulation Am J Ophthalmol 2017177159e68

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Pharmaceutical to stimulate nerves

bullNasal Spray OC-01

bullOyster Point Pharma

bullStimulate natural tears

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Amniotic cytokine extract(Ocular Science)bullACE is a novel drop marketed as Genesis bullContains various cytokines growth factor

and anti-inflammatory moleculesbull Effective in a small pilot study

Amniotic Cytokine Extract Promising in Patients with Dry Ey Disease MDLinx

httpswwwmdlinxcomophthalmologyarticle1280 1113088 Accessed Jan 27 2018

Amniotic Cytokine Extract Promising in Patients with Dry Ey Disease MDLinx

httpswwwmdlinxcomophthalmologyarticle1280 1113088 Accessed Jan 27 2

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Recombinant human nerve growth factor (OxervateTM eye drops Dompeacute)

bull FDA Approval Aug 2018o First approved drug for Neurotropic keratitis (NK) ndashdegenerative disease with loss of corneal sensation o Topical eye drop o Clinical evidence of complete corneal healing in 70 of patients treated with Oxervate after 8 weeks1

1Bonini S et al Phase II Randomized Double-Masked Vehicle-Controlled Trial of Recombinant Human Nerve Growth Factor for Neurotrophic Keratitis Ophthalmology 125 1332ndash1343 (2018)

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Perfluorohexyloctane (NovaTears Novaliq)

bull Main effect prevent evaporative DED by increasing tear film and lipid layer thickness

bull Approved in Europe Australia and New Zealandbull Clinical evidence of increased tear production and tear film

stability as well as significant decrease in OSDI scores and in corneal staining1

1Steven P et al Semifluorinated Alkane Eye Drops for Treatment of Dry Eye Disease ndash A Prospective Multicenter Noninterventional Study J Ocul Pharmacol Ther 2015 Oct 1 31(8) 498-503

Corneal Epithelium Healing

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CrossThiolated Carboxymethyl Hyaluronic Acid Liquid-Gel

(Ocular Bandage Gel EyeGate Pharma)

bull Main effects accelerate corneal healing and reduce corneal stainingo Indicated for defects due to photorefcrative keratectomy (PRK)o Indicated for Punctate epitheliopathies (PE) associated with

dry eyebull Treatment in development July 2018 approval to conduct two

pilot studies using OBG for PE and PRKbull A first-in-human pilot study (n=39) showed accelerated corneal

reepithelialization through slit lamp examination at day 1 after PRK Further studies needed1

1Durrie Daniel S et al Ability of a new crosslinked polymer ocular bandage gel to accelerate reepithelialization after photorefractive keratectomy Journal of Cataract amp Refractive Surgery 443 (2018) 369-375

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Biologic MoleculesDry Eye Assessment

bull Proteoglycan-4 (Lubricin)oRecently discovered on the ocular surface in the meibomian glands2

oFunctions to prevent friction at the cornea-lid interface and has anti-inflammatory propertiesoCommercial lubricin-based lubricants remain scarceoEvidence from clinical studies with recombinant human lubricin suggest

significant improvement in signs and symptoms of DED through TBUT corneal staining and eyelid and conjunctival redness3

1De Paiva CS Chotikavanich S Pangelinan SB Pitcher 3rd JD Fang B Zheng X et al IL-17 disrupts corneal barrier following desiccating stress Mucosal Immunol 20092(3)243ndash2532Iqbal SM Leonard C Regmi SC De Rantere D Tailor P Ren G et al LubricinProteoglycan 4 binds to and regulates the activity of Toll-Like Receptors In Vitro Sci Rep20166189103Lambiase A Sullivan BD Schmidt TA Sullivan DA Jay GD Truitt ER et al A Two-Week Randomized Double-masked Study to Evaluate Safety and Efficacy of Lubricin

(150 mugmL) Eye Drops Versus Sodium Hyaluronate (HA) 018 Eye Drops (Vismed(R)) in Patients with Moderate Dry Eye Disease Ocul Surf 20171577ndash87

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Why Ocular Biomarkers

Surrogate Endpoints- None accepted by the FDA or Europe to date Validation needed- clear clinical relevance

Enrichment of Study Population Still regulatory hurdles

Support mechanism of action of treatment Topical ciclosporin in Europe for Dry eyes (Europe2015 Ikervis)1

SEGMENT THE DRY EYE POPULATION- TREAT MORE SPECIFICALLY-PERSONALIZE TREATMENT

1 Ikervis SmPC June 2015 available at httpswwwmedicinesorgukemcmedicine30584

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Strengths of DREAM

bullGeneralizability ω3 added to existing treatments in patients who still had symptoms and signs despite Rx ndash REAL WORLD PATIENTSbullComparability of Groups Randomization ldquoworkedrdquobullCompliance

bull Drugs delivered to home even when missed visit

bull High rates of compliance by blood testbull Missed visit rate lt 10

bull Treatment bull Highest dose (3000 mg) of ω3 in any DED RCTbull Triglyceride ω3 form more bioavailable than ethyl esterbull Content verified by an outside laboratorybull Softgels active identical to placebobull 12 months ndash reduce seasonality effects

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New Treatment Options

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Meibomian Gland Dysfunctionbull A leading cause of Dry Eye1

bull Clinical signs of MGD2o Aberrant medium production andor composition due to Obstruction of meibomian gland (a) Gland dropout (b) Change in gland secretion (c)

bull Patients complaining of repeated lsquostyesrsquo

bull Characterized by tear film instability and rapid TFBUT1Nichols KK Foulks GN Bron AJ et al The International Workshop on Meibomian Gland Dysfunction Executive Summary

Investigative Ophthalmology amp Visual Science 201152(4)1922-19292American Academy of Ophthalmology Retina Panel Preferred Practice PatternregGuidelines Blepharitis San Francisco

CA American Academy of Ophthalmology 2008 Available at httpwwwaaoorgppp

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Meibomian Gland Dysfunction - Treatments

Heating amp Pressure Devices

bull Lipiflow

bull Intense Pulsed Light (IPL)

bull iLux

bull Blephex

bull NuLids

bull Blephasteam

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LipiFlowreg TearScience

bull FDA clearancebull Thermal pulsation Devicebull 12 minute treatmentbull Delivers heat to the inner eyelid and massage to the outside unblock the flow of lipids from the meibomian glandsbull Preliminary evidence At 3 months-1 year follow-up improved symptoms and signs (secretions TBUT)1-5

1Lane SS et al Cornea 2012 Apr31(4)396-4042Greiner JV Curr Eye Res 2012 Apr37(4)272-83Greiner JV Clin Experiment Ophthalmol 2013 Aug41(6)524-304Finis D et al Ocul Surf 2014 Apr12(2)146-545Finis D et al Cornea 2014 Dec33(12)1265-70

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Intense Pulsed Light (IPL) Lumenis or E-eyeMain effect lower eyelidsHypothesized mechanism of action1) Treat abnormal blood vessels near eyelid to close them off decrease inflammation2) Thermal treatment softens the glands and allows to discharge secretions more readilySome evidence of therapeutic potential but further studies needed1-2

1Toyos R et al Photomed Laser Surg 2015 January 1 33(1) 41ndash462Craig JP et al Invest Ophthalmol Vis Sci 2015 Feb 1256(3)1965-70 doi 101167iovs14-15764

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iLuxreg Tear Film Innovationsbull Main effect unblocks Meibomian glandsbull Heat amp pressure therapybull 8-12 min treatmentbull Handheld Devicebull Glands can be viewed via magnifier

bull No clinically significant differences between iLux and LipiFlow with respect to indication for use and device performance1

1ldquo510(K) SUMMARY ndash K172645rdquo US Food amp Drug Administration Dec 2017 wwwaccessdatafdagovcdrh_docspdf17K172645pdf

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BlephExreg Rysurgbull FDA clearance bull Main effect lid margin debridement bull 6-8 minute treatmentbull In-officebull Lasts three to six months before requiring a

retreatmentbull Evidence of improvement for contact lens

wearers through significant reduction in bacterial load on patientsrsquo eyelids1

1Siddireddy JS Tan-Showyin J Vijay AK Willcox M A Comfortable Eye Needs Fats Presented at the University of New South Wales Sydney Australia 2015

Rysurgcom

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Blephasteamreg Laboratoires Theacuteabull Main effect warming goggles that promote fluidization Meibomian glands secretions through heat and pressure bull ESPOIR Study evidence of significant improvement in symptoms using the visual analogous scale (VAS)1

bull Expensive devicebull Need further studies with larger samples sizes

to determine efficacy2

1 Doan S Chiambaretta F Gabison EE Cochereau I Baudoin C Efficacy of heating wet chamber warming goggles (Blephasteamreg) in adult posterior blepharitis Invest Opthalmol Vis Sci 201152 E-Abstract 38332Benitez Del Castillo JM Kaercher T Mansour K Wylegala E Dua H Evaluation of the efficacy safety and acceptability of an eyelid warming device for the treatment of meibomian gland dysfunction Clin Ophthalmol 201482019ndash2027

2018

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NuLidstrade NuSight

bull Main effect lid scrub that stimulates Meibomian glands by removing biofilm and scurf that block the opening of the glands

bull Doctor-prescribed In-home treatmentbull 60 second daily treatmentbull A multi-center clinical study showed

evidence of 50 decrease in dry eye symptoms 65 improvement in TBUT and 81 improvement in Meibomian Gland liquid secretions1

1Schanzlin Olkowski Coble Gross NuLids II Study April 2018

2018

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TearCare System Sight Sciences

bull First wearable therapeutic eyelid therapy devicebull In-office treatmentbull 12 minute thermal eyelid treatment followed by expression forceps to

manually evacuate residual obstructionsbull Evidence from pilot study suggested improved TBUT corneal and

conjunctival staining scored and dry eye symptoms based on OSDI SPEED and SANDE1

bull Further clinical evidence underway

Badawi David A novel system TearCarereg for the treatment of the signs and symptoms of dry eye disease Clinical Ophthalmology (Auckland NZ) 12 (2018) 683

2018

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Anti-Inflammatory Pharmaceuticals

Cyclosporine

Main effectbull Anti-inflammatory therapy

bull Inhibits T-cell maturation

bull Decreases pro-inflammatory cytokines

bull Upregulates anti-inflammatory cytokines20

18 copy

48th

Europ

ean C

ontac

t Len

s Soc

iety O

f Oph

thalm

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ts A

ll righ

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serve

d - A

ny re

prod

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n eve

n in p

art is

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Cyclosporine A cationic emulsion 01 (Ikervisreg Santen)

bull Approved in Europe in 2015bull Main effect prolonged precorneal residence time and improved

bioavailabilityo Indicated for patients with severe DED that has not improved

using tear substitutesbull Clinical evidence of reduced HLA-DR expression at 6 mo measured

through impression cytology overall greater benefits for patients with Sjoumlgrenrsquos Syndrome1

1Leonardi A Messmer EM Labetoulle M et al Efficacy and safety of 01 ciclosporin A cationic emulsion in dry eye disease a pooled analysis of two double-masked randomised vehicle-controlled phase III clinical studies Br J Ophthalmol 2018

2018

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Cyclosporine 009 (OTX-101 CequaTM Sun Pharma)

bull FDA Approval Aug 2018

bull Highest FDA-approved concentration of cyclosporine A1

bull Main effect Increase tear production

bull Calcineurin inhibitor

bull Nanomicellar formulation eases entry into corneal and conjunctival cells

bull Two multicenter studies report a statistically significant increase (ge 10 mm) in Schirmer wetting at 3 mo in patients receiving CequaTM vs vehicle1

Cyclosporine - New Preparations

Biospacecom

1epgonlineorg ldquoFDA Approves CEQUA to Treat Dry Eye Syndrome- Sun Pharma + Sun Ophthalmicsrdquo Epgonlineorg Aug 2018 wwwepgonlineorgusnewsfda-approves-cequa-to-treat-dry-eye-syndrome---sun-pharma---sun--ophthalmics-html

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Cyclosporine 005 and 01 (CyclASol Novaliq)

bull Semifluorinated alkanes formulation better dissolves Cyclosporine Abull Greater penetration than FDA-approved 005 Cyclosporine A

(Restasis)bull Evidence of decreased corneal and conjunctival staining after 14

days2

bull It remains unknown whether greater concentration leads to better results phase 3 studies are underway3

2Novaliq CyclASolreg ndash Cyclosporine in SFA for Ophthalmological Application to Treat Dry Eye Syndrome 20153 Lallemand F Shmitt M Bourges JL et al Cyclosporine A delivery to the eye a comprehensive review of academic and industrial efforts Eur J Pharm Biopharm 201711714-28

2018

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Cyclosporin with chondroiton sulphate

Klarity- C

Imprimis- compounded

chondroitin sulfate

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SkQ1 bull Main effects synthesized small molecule targeted to reduce oxidative stress in cellmitochondria

o Regenerates itself o SkQ1 ophthalmic solution is indicated for pathologies of the eye associated with

oxidative stress such as dry eye 1

o Approved in Russia (2011) and marketed as Visomitinbull Clinical evidence suggest statistically significant 2

o Decrease in corneal stainingo Improvements in lid margin rednesso Improvements in symptoms measuredo through Ora CalibraTM scales

1Wakamatsu TH Dogru M Tsubota K Tearful relations oxidative stress inflammation and eye diseases Arq Bras Oftalmol 200871(6 Suppl)72ndash92Petrov Anton et al SkQ1 ophthalmic solution for dry eye treatment results of a phase 2 safety and efficacy clinical study in the environment and during challenge in the controlled adverse environment model Advances in therapy 331 (2016) 96-115

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Steroids- new formulation bullKPI-121- Kala Pharmaceuticals

bullMucous ndash penetrating particle ( MPP) ndashbullnano particles

bullLoteprednol -025

bull Better penetration low dose steroid

bullEpisodic flare ups of DED

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ADX-102 (Reproxalap Aldeyra Therapeutics)bull Small molecule topical agentbull Traps aldehydes that usually activate inflammatory factorsbull Positive clinical evidence of improvement in signs and

symptoms of dry eye1

Thymosin beta 4 (Tβ4 ) bull 43-amino acid G-actin binding proteinbull Downregulates transcription of inflammatory mediators and promotes corneal

epithelial cell migrationbull Phase 3 clinical trial with Tβ4 (RGN-259 RegeneRx) showed improvement in signs

and symptoms of dry eye through corneal staining tear production and expression of inflammatory factors2

1Aldehyde trap drug rapidly improves signs symptoms of dry eye disease American Academy of Ophthalmology (2017) httpswwwaaoorgheadlinealdehyde-trap-drug-rapidly-improves-signs-symptoms2Kim Chae Eun et al RGN-259 (thymosin β4) improves clinically important dry eye efficacies in comparison with prescription drugs in a dry eye model Scientific reports 81 (2018) 10500

Aldeyracom

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Tear Enhancements

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bull Currently approved in Japan and South Korea1

bull Main Effect Increase tear fluid and mucin secretion on the ocular surface through interaction with P2Y2 receptors in the conjunctiva

bull Evidence from clinical trials suggest diquafosol improves corneal staining more effectively than a comparable sodium hyaluronate solution2

Diquafosol Tetrasodium(3 Ophthalmic Solution)

1Koh Shizuka Clinical utility of 3 diquafosol ophthalmic solution in the treatment of dry eyes Clinical Ophthalmology (Auckland NZ) 9 (2015) 8652Takamura Etsuko et al A randomised double-masked comparison study of diquafosol versus sodium hyaluronate ophthalmic solutions in dry eye patients British Journal of Ophthalmology 9610 (2012) 1310-1315

Pubmedcom

Santencom

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Rebapimide

(2 Ophthalmic Solution)

bull Currently approved in Japanbull Main Effect stimulates mucin secretagogue activity in

cornea and conjunctivabull Clinical evidence suggests

o Statistically significant Improvement in corneal and conjunctival staining as well as in quality of life as well as in tear break-up time12

o Potential role in suppressing the expression of inflammatory proteins (Polyl)3

1 Kinoshita Shigeru et al Rebamipide (OPC-12759) in the treatment of dry eye a randomized double-masked multicenter placebo-controlled phase II study Ophthalmology11912 (2012) 2471-24782 Kashima Tomoyuki et al Rebamipide ophthalmic suspension for the treatment of dry eye syndrome a critical appraisal Clinical ophthalmology (Auckland NZ) 8 (2014) 10033Ueta Mayumi et al Rebamipide suppresses PolyI C-stimulated cytokine production in human conjunctival epithelial cells Journal of Ocular Pharmacology and Therapeutics 297 (2013) 688-693

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TrueTearreg Allerganbull FDA Clearancebull Main effect intranasal applicator sends

electrical currents to nerves that stimulate tear production

bull Evidence of improved Schirmer scores decreased symptoms and corneal and conjunctival staining at 6 mo Ocular comfort lasted for 3 hours following neurostimulationo Secondary effect intranasal application

promotes goblet cell mucin secretion which stabilizes the tear film1

Truetearcom

1Gumus K Schuetzle KL Pflugfelder SC Randomized controlled crossover trial comparing the impact of sham or intranasal tear neurostimulation on 654 GD Novack et al The Ocular Surface xxx (2017) 635e655 conjunctival goblet cell degranulation Am J Ophthalmol 2017177159e68

2018

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Pharmaceutical to stimulate nerves

bullNasal Spray OC-01

bullOyster Point Pharma

bullStimulate natural tears

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Amniotic cytokine extract(Ocular Science)bullACE is a novel drop marketed as Genesis bullContains various cytokines growth factor

and anti-inflammatory moleculesbull Effective in a small pilot study

Amniotic Cytokine Extract Promising in Patients with Dry Ey Disease MDLinx

httpswwwmdlinxcomophthalmologyarticle1280 1113088 Accessed Jan 27 2018

Amniotic Cytokine Extract Promising in Patients with Dry Ey Disease MDLinx

httpswwwmdlinxcomophthalmologyarticle1280 1113088 Accessed Jan 27 2

2018

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Recombinant human nerve growth factor (OxervateTM eye drops Dompeacute)

bull FDA Approval Aug 2018o First approved drug for Neurotropic keratitis (NK) ndashdegenerative disease with loss of corneal sensation o Topical eye drop o Clinical evidence of complete corneal healing in 70 of patients treated with Oxervate after 8 weeks1

1Bonini S et al Phase II Randomized Double-Masked Vehicle-Controlled Trial of Recombinant Human Nerve Growth Factor for Neurotrophic Keratitis Ophthalmology 125 1332ndash1343 (2018)

2018

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Perfluorohexyloctane (NovaTears Novaliq)

bull Main effect prevent evaporative DED by increasing tear film and lipid layer thickness

bull Approved in Europe Australia and New Zealandbull Clinical evidence of increased tear production and tear film

stability as well as significant decrease in OSDI scores and in corneal staining1

1Steven P et al Semifluorinated Alkane Eye Drops for Treatment of Dry Eye Disease ndash A Prospective Multicenter Noninterventional Study J Ocul Pharmacol Ther 2015 Oct 1 31(8) 498-503

Corneal Epithelium Healing

2018

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CrossThiolated Carboxymethyl Hyaluronic Acid Liquid-Gel

(Ocular Bandage Gel EyeGate Pharma)

bull Main effects accelerate corneal healing and reduce corneal stainingo Indicated for defects due to photorefcrative keratectomy (PRK)o Indicated for Punctate epitheliopathies (PE) associated with

dry eyebull Treatment in development July 2018 approval to conduct two

pilot studies using OBG for PE and PRKbull A first-in-human pilot study (n=39) showed accelerated corneal

reepithelialization through slit lamp examination at day 1 after PRK Further studies needed1

1Durrie Daniel S et al Ability of a new crosslinked polymer ocular bandage gel to accelerate reepithelialization after photorefractive keratectomy Journal of Cataract amp Refractive Surgery 443 (2018) 369-375

2018

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Biologic MoleculesDry Eye Assessment

bull Proteoglycan-4 (Lubricin)oRecently discovered on the ocular surface in the meibomian glands2

oFunctions to prevent friction at the cornea-lid interface and has anti-inflammatory propertiesoCommercial lubricin-based lubricants remain scarceoEvidence from clinical studies with recombinant human lubricin suggest

significant improvement in signs and symptoms of DED through TBUT corneal staining and eyelid and conjunctival redness3

1De Paiva CS Chotikavanich S Pangelinan SB Pitcher 3rd JD Fang B Zheng X et al IL-17 disrupts corneal barrier following desiccating stress Mucosal Immunol 20092(3)243ndash2532Iqbal SM Leonard C Regmi SC De Rantere D Tailor P Ren G et al LubricinProteoglycan 4 binds to and regulates the activity of Toll-Like Receptors In Vitro Sci Rep20166189103Lambiase A Sullivan BD Schmidt TA Sullivan DA Jay GD Truitt ER et al A Two-Week Randomized Double-masked Study to Evaluate Safety and Efficacy of Lubricin

(150 mugmL) Eye Drops Versus Sodium Hyaluronate (HA) 018 Eye Drops (Vismed(R)) in Patients with Moderate Dry Eye Disease Ocul Surf 20171577ndash87

2018

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Why Ocular Biomarkers

Surrogate Endpoints- None accepted by the FDA or Europe to date Validation needed- clear clinical relevance

Enrichment of Study Population Still regulatory hurdles

Support mechanism of action of treatment Topical ciclosporin in Europe for Dry eyes (Europe2015 Ikervis)1

SEGMENT THE DRY EYE POPULATION- TREAT MORE SPECIFICALLY-PERSONALIZE TREATMENT

1 Ikervis SmPC June 2015 available at httpswwwmedicinesorgukemcmedicine30584

2018

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New Treatment Options

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Meibomian Gland Dysfunctionbull A leading cause of Dry Eye1

bull Clinical signs of MGD2o Aberrant medium production andor composition due to Obstruction of meibomian gland (a) Gland dropout (b) Change in gland secretion (c)

bull Patients complaining of repeated lsquostyesrsquo

bull Characterized by tear film instability and rapid TFBUT1Nichols KK Foulks GN Bron AJ et al The International Workshop on Meibomian Gland Dysfunction Executive Summary

Investigative Ophthalmology amp Visual Science 201152(4)1922-19292American Academy of Ophthalmology Retina Panel Preferred Practice PatternregGuidelines Blepharitis San Francisco

CA American Academy of Ophthalmology 2008 Available at httpwwwaaoorgppp

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Meibomian Gland Dysfunction - Treatments

Heating amp Pressure Devices

bull Lipiflow

bull Intense Pulsed Light (IPL)

bull iLux

bull Blephex

bull NuLids

bull Blephasteam

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LipiFlowreg TearScience

bull FDA clearancebull Thermal pulsation Devicebull 12 minute treatmentbull Delivers heat to the inner eyelid and massage to the outside unblock the flow of lipids from the meibomian glandsbull Preliminary evidence At 3 months-1 year follow-up improved symptoms and signs (secretions TBUT)1-5

1Lane SS et al Cornea 2012 Apr31(4)396-4042Greiner JV Curr Eye Res 2012 Apr37(4)272-83Greiner JV Clin Experiment Ophthalmol 2013 Aug41(6)524-304Finis D et al Ocul Surf 2014 Apr12(2)146-545Finis D et al Cornea 2014 Dec33(12)1265-70

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Intense Pulsed Light (IPL) Lumenis or E-eyeMain effect lower eyelidsHypothesized mechanism of action1) Treat abnormal blood vessels near eyelid to close them off decrease inflammation2) Thermal treatment softens the glands and allows to discharge secretions more readilySome evidence of therapeutic potential but further studies needed1-2

1Toyos R et al Photomed Laser Surg 2015 January 1 33(1) 41ndash462Craig JP et al Invest Ophthalmol Vis Sci 2015 Feb 1256(3)1965-70 doi 101167iovs14-15764

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iLuxreg Tear Film Innovationsbull Main effect unblocks Meibomian glandsbull Heat amp pressure therapybull 8-12 min treatmentbull Handheld Devicebull Glands can be viewed via magnifier

bull No clinically significant differences between iLux and LipiFlow with respect to indication for use and device performance1

1ldquo510(K) SUMMARY ndash K172645rdquo US Food amp Drug Administration Dec 2017 wwwaccessdatafdagovcdrh_docspdf17K172645pdf

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BlephExreg Rysurgbull FDA clearance bull Main effect lid margin debridement bull 6-8 minute treatmentbull In-officebull Lasts three to six months before requiring a

retreatmentbull Evidence of improvement for contact lens

wearers through significant reduction in bacterial load on patientsrsquo eyelids1

1Siddireddy JS Tan-Showyin J Vijay AK Willcox M A Comfortable Eye Needs Fats Presented at the University of New South Wales Sydney Australia 2015

Rysurgcom

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Blephasteamreg Laboratoires Theacuteabull Main effect warming goggles that promote fluidization Meibomian glands secretions through heat and pressure bull ESPOIR Study evidence of significant improvement in symptoms using the visual analogous scale (VAS)1

bull Expensive devicebull Need further studies with larger samples sizes

to determine efficacy2

1 Doan S Chiambaretta F Gabison EE Cochereau I Baudoin C Efficacy of heating wet chamber warming goggles (Blephasteamreg) in adult posterior blepharitis Invest Opthalmol Vis Sci 201152 E-Abstract 38332Benitez Del Castillo JM Kaercher T Mansour K Wylegala E Dua H Evaluation of the efficacy safety and acceptability of an eyelid warming device for the treatment of meibomian gland dysfunction Clin Ophthalmol 201482019ndash2027

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NuLidstrade NuSight

bull Main effect lid scrub that stimulates Meibomian glands by removing biofilm and scurf that block the opening of the glands

bull Doctor-prescribed In-home treatmentbull 60 second daily treatmentbull A multi-center clinical study showed

evidence of 50 decrease in dry eye symptoms 65 improvement in TBUT and 81 improvement in Meibomian Gland liquid secretions1

1Schanzlin Olkowski Coble Gross NuLids II Study April 2018

2018

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TearCare System Sight Sciences

bull First wearable therapeutic eyelid therapy devicebull In-office treatmentbull 12 minute thermal eyelid treatment followed by expression forceps to

manually evacuate residual obstructionsbull Evidence from pilot study suggested improved TBUT corneal and

conjunctival staining scored and dry eye symptoms based on OSDI SPEED and SANDE1

bull Further clinical evidence underway

Badawi David A novel system TearCarereg for the treatment of the signs and symptoms of dry eye disease Clinical Ophthalmology (Auckland NZ) 12 (2018) 683

2018

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Anti-Inflammatory Pharmaceuticals

Cyclosporine

Main effectbull Anti-inflammatory therapy

bull Inhibits T-cell maturation

bull Decreases pro-inflammatory cytokines

bull Upregulates anti-inflammatory cytokines20

18 copy

48th

Europ

ean C

ontac

t Len

s Soc

iety O

f Oph

thalm

ologis

ts A

ll righ

ts re

serve

d - A

ny re

prod

uctio

n eve

n in p

art is

proh

ibited

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Cyclosporine A cationic emulsion 01 (Ikervisreg Santen)

bull Approved in Europe in 2015bull Main effect prolonged precorneal residence time and improved

bioavailabilityo Indicated for patients with severe DED that has not improved

using tear substitutesbull Clinical evidence of reduced HLA-DR expression at 6 mo measured

through impression cytology overall greater benefits for patients with Sjoumlgrenrsquos Syndrome1

1Leonardi A Messmer EM Labetoulle M et al Efficacy and safety of 01 ciclosporin A cationic emulsion in dry eye disease a pooled analysis of two double-masked randomised vehicle-controlled phase III clinical studies Br J Ophthalmol 2018

2018

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Cyclosporine 009 (OTX-101 CequaTM Sun Pharma)

bull FDA Approval Aug 2018

bull Highest FDA-approved concentration of cyclosporine A1

bull Main effect Increase tear production

bull Calcineurin inhibitor

bull Nanomicellar formulation eases entry into corneal and conjunctival cells

bull Two multicenter studies report a statistically significant increase (ge 10 mm) in Schirmer wetting at 3 mo in patients receiving CequaTM vs vehicle1

Cyclosporine - New Preparations

Biospacecom

1epgonlineorg ldquoFDA Approves CEQUA to Treat Dry Eye Syndrome- Sun Pharma + Sun Ophthalmicsrdquo Epgonlineorg Aug 2018 wwwepgonlineorgusnewsfda-approves-cequa-to-treat-dry-eye-syndrome---sun-pharma---sun--ophthalmics-html

2018

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Cyclosporine 005 and 01 (CyclASol Novaliq)

bull Semifluorinated alkanes formulation better dissolves Cyclosporine Abull Greater penetration than FDA-approved 005 Cyclosporine A

(Restasis)bull Evidence of decreased corneal and conjunctival staining after 14

days2

bull It remains unknown whether greater concentration leads to better results phase 3 studies are underway3

2Novaliq CyclASolreg ndash Cyclosporine in SFA for Ophthalmological Application to Treat Dry Eye Syndrome 20153 Lallemand F Shmitt M Bourges JL et al Cyclosporine A delivery to the eye a comprehensive review of academic and industrial efforts Eur J Pharm Biopharm 201711714-28

2018

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Cyclosporin with chondroiton sulphate

Klarity- C

Imprimis- compounded

chondroitin sulfate

2018

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2018

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SkQ1 bull Main effects synthesized small molecule targeted to reduce oxidative stress in cellmitochondria

o Regenerates itself o SkQ1 ophthalmic solution is indicated for pathologies of the eye associated with

oxidative stress such as dry eye 1

o Approved in Russia (2011) and marketed as Visomitinbull Clinical evidence suggest statistically significant 2

o Decrease in corneal stainingo Improvements in lid margin rednesso Improvements in symptoms measuredo through Ora CalibraTM scales

1Wakamatsu TH Dogru M Tsubota K Tearful relations oxidative stress inflammation and eye diseases Arq Bras Oftalmol 200871(6 Suppl)72ndash92Petrov Anton et al SkQ1 ophthalmic solution for dry eye treatment results of a phase 2 safety and efficacy clinical study in the environment and during challenge in the controlled adverse environment model Advances in therapy 331 (2016) 96-115

2018

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Steroids- new formulation bullKPI-121- Kala Pharmaceuticals

bullMucous ndash penetrating particle ( MPP) ndashbullnano particles

bullLoteprednol -025

bull Better penetration low dose steroid

bullEpisodic flare ups of DED

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ADX-102 (Reproxalap Aldeyra Therapeutics)bull Small molecule topical agentbull Traps aldehydes that usually activate inflammatory factorsbull Positive clinical evidence of improvement in signs and

symptoms of dry eye1

Thymosin beta 4 (Tβ4 ) bull 43-amino acid G-actin binding proteinbull Downregulates transcription of inflammatory mediators and promotes corneal

epithelial cell migrationbull Phase 3 clinical trial with Tβ4 (RGN-259 RegeneRx) showed improvement in signs

and symptoms of dry eye through corneal staining tear production and expression of inflammatory factors2

1Aldehyde trap drug rapidly improves signs symptoms of dry eye disease American Academy of Ophthalmology (2017) httpswwwaaoorgheadlinealdehyde-trap-drug-rapidly-improves-signs-symptoms2Kim Chae Eun et al RGN-259 (thymosin β4) improves clinically important dry eye efficacies in comparison with prescription drugs in a dry eye model Scientific reports 81 (2018) 10500

Aldeyracom

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Tear Enhancements

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bull Currently approved in Japan and South Korea1

bull Main Effect Increase tear fluid and mucin secretion on the ocular surface through interaction with P2Y2 receptors in the conjunctiva

bull Evidence from clinical trials suggest diquafosol improves corneal staining more effectively than a comparable sodium hyaluronate solution2

Diquafosol Tetrasodium(3 Ophthalmic Solution)

1Koh Shizuka Clinical utility of 3 diquafosol ophthalmic solution in the treatment of dry eyes Clinical Ophthalmology (Auckland NZ) 9 (2015) 8652Takamura Etsuko et al A randomised double-masked comparison study of diquafosol versus sodium hyaluronate ophthalmic solutions in dry eye patients British Journal of Ophthalmology 9610 (2012) 1310-1315

Pubmedcom

Santencom

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Rebapimide

(2 Ophthalmic Solution)

bull Currently approved in Japanbull Main Effect stimulates mucin secretagogue activity in

cornea and conjunctivabull Clinical evidence suggests

o Statistically significant Improvement in corneal and conjunctival staining as well as in quality of life as well as in tear break-up time12

o Potential role in suppressing the expression of inflammatory proteins (Polyl)3

1 Kinoshita Shigeru et al Rebamipide (OPC-12759) in the treatment of dry eye a randomized double-masked multicenter placebo-controlled phase II study Ophthalmology11912 (2012) 2471-24782 Kashima Tomoyuki et al Rebamipide ophthalmic suspension for the treatment of dry eye syndrome a critical appraisal Clinical ophthalmology (Auckland NZ) 8 (2014) 10033Ueta Mayumi et al Rebamipide suppresses PolyI C-stimulated cytokine production in human conjunctival epithelial cells Journal of Ocular Pharmacology and Therapeutics 297 (2013) 688-693

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TrueTearreg Allerganbull FDA Clearancebull Main effect intranasal applicator sends

electrical currents to nerves that stimulate tear production

bull Evidence of improved Schirmer scores decreased symptoms and corneal and conjunctival staining at 6 mo Ocular comfort lasted for 3 hours following neurostimulationo Secondary effect intranasal application

promotes goblet cell mucin secretion which stabilizes the tear film1

Truetearcom

1Gumus K Schuetzle KL Pflugfelder SC Randomized controlled crossover trial comparing the impact of sham or intranasal tear neurostimulation on 654 GD Novack et al The Ocular Surface xxx (2017) 635e655 conjunctival goblet cell degranulation Am J Ophthalmol 2017177159e68

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Pharmaceutical to stimulate nerves

bullNasal Spray OC-01

bullOyster Point Pharma

bullStimulate natural tears

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Amniotic cytokine extract(Ocular Science)bullACE is a novel drop marketed as Genesis bullContains various cytokines growth factor

and anti-inflammatory moleculesbull Effective in a small pilot study

Amniotic Cytokine Extract Promising in Patients with Dry Ey Disease MDLinx

httpswwwmdlinxcomophthalmologyarticle1280 1113088 Accessed Jan 27 2018

Amniotic Cytokine Extract Promising in Patients with Dry Ey Disease MDLinx

httpswwwmdlinxcomophthalmologyarticle1280 1113088 Accessed Jan 27 2

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Recombinant human nerve growth factor (OxervateTM eye drops Dompeacute)

bull FDA Approval Aug 2018o First approved drug for Neurotropic keratitis (NK) ndashdegenerative disease with loss of corneal sensation o Topical eye drop o Clinical evidence of complete corneal healing in 70 of patients treated with Oxervate after 8 weeks1

1Bonini S et al Phase II Randomized Double-Masked Vehicle-Controlled Trial of Recombinant Human Nerve Growth Factor for Neurotrophic Keratitis Ophthalmology 125 1332ndash1343 (2018)

2018

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Perfluorohexyloctane (NovaTears Novaliq)

bull Main effect prevent evaporative DED by increasing tear film and lipid layer thickness

bull Approved in Europe Australia and New Zealandbull Clinical evidence of increased tear production and tear film

stability as well as significant decrease in OSDI scores and in corneal staining1

1Steven P et al Semifluorinated Alkane Eye Drops for Treatment of Dry Eye Disease ndash A Prospective Multicenter Noninterventional Study J Ocul Pharmacol Ther 2015 Oct 1 31(8) 498-503

Corneal Epithelium Healing

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CrossThiolated Carboxymethyl Hyaluronic Acid Liquid-Gel

(Ocular Bandage Gel EyeGate Pharma)

bull Main effects accelerate corneal healing and reduce corneal stainingo Indicated for defects due to photorefcrative keratectomy (PRK)o Indicated for Punctate epitheliopathies (PE) associated with

dry eyebull Treatment in development July 2018 approval to conduct two

pilot studies using OBG for PE and PRKbull A first-in-human pilot study (n=39) showed accelerated corneal

reepithelialization through slit lamp examination at day 1 after PRK Further studies needed1

1Durrie Daniel S et al Ability of a new crosslinked polymer ocular bandage gel to accelerate reepithelialization after photorefractive keratectomy Journal of Cataract amp Refractive Surgery 443 (2018) 369-375

2018

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Biologic MoleculesDry Eye Assessment

bull Proteoglycan-4 (Lubricin)oRecently discovered on the ocular surface in the meibomian glands2

oFunctions to prevent friction at the cornea-lid interface and has anti-inflammatory propertiesoCommercial lubricin-based lubricants remain scarceoEvidence from clinical studies with recombinant human lubricin suggest

significant improvement in signs and symptoms of DED through TBUT corneal staining and eyelid and conjunctival redness3

1De Paiva CS Chotikavanich S Pangelinan SB Pitcher 3rd JD Fang B Zheng X et al IL-17 disrupts corneal barrier following desiccating stress Mucosal Immunol 20092(3)243ndash2532Iqbal SM Leonard C Regmi SC De Rantere D Tailor P Ren G et al LubricinProteoglycan 4 binds to and regulates the activity of Toll-Like Receptors In Vitro Sci Rep20166189103Lambiase A Sullivan BD Schmidt TA Sullivan DA Jay GD Truitt ER et al A Two-Week Randomized Double-masked Study to Evaluate Safety and Efficacy of Lubricin

(150 mugmL) Eye Drops Versus Sodium Hyaluronate (HA) 018 Eye Drops (Vismed(R)) in Patients with Moderate Dry Eye Disease Ocul Surf 20171577ndash87

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Why Ocular Biomarkers

Surrogate Endpoints- None accepted by the FDA or Europe to date Validation needed- clear clinical relevance

Enrichment of Study Population Still regulatory hurdles

Support mechanism of action of treatment Topical ciclosporin in Europe for Dry eyes (Europe2015 Ikervis)1

SEGMENT THE DRY EYE POPULATION- TREAT MORE SPECIFICALLY-PERSONALIZE TREATMENT

1 Ikervis SmPC June 2015 available at httpswwwmedicinesorgukemcmedicine30584

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Meibomian Gland Dysfunctionbull A leading cause of Dry Eye1

bull Clinical signs of MGD2o Aberrant medium production andor composition due to Obstruction of meibomian gland (a) Gland dropout (b) Change in gland secretion (c)

bull Patients complaining of repeated lsquostyesrsquo

bull Characterized by tear film instability and rapid TFBUT1Nichols KK Foulks GN Bron AJ et al The International Workshop on Meibomian Gland Dysfunction Executive Summary

Investigative Ophthalmology amp Visual Science 201152(4)1922-19292American Academy of Ophthalmology Retina Panel Preferred Practice PatternregGuidelines Blepharitis San Francisco

CA American Academy of Ophthalmology 2008 Available at httpwwwaaoorgppp

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Meibomian Gland Dysfunction - Treatments

Heating amp Pressure Devices

bull Lipiflow

bull Intense Pulsed Light (IPL)

bull iLux

bull Blephex

bull NuLids

bull Blephasteam

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LipiFlowreg TearScience

bull FDA clearancebull Thermal pulsation Devicebull 12 minute treatmentbull Delivers heat to the inner eyelid and massage to the outside unblock the flow of lipids from the meibomian glandsbull Preliminary evidence At 3 months-1 year follow-up improved symptoms and signs (secretions TBUT)1-5

1Lane SS et al Cornea 2012 Apr31(4)396-4042Greiner JV Curr Eye Res 2012 Apr37(4)272-83Greiner JV Clin Experiment Ophthalmol 2013 Aug41(6)524-304Finis D et al Ocul Surf 2014 Apr12(2)146-545Finis D et al Cornea 2014 Dec33(12)1265-70

2018

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Intense Pulsed Light (IPL) Lumenis or E-eyeMain effect lower eyelidsHypothesized mechanism of action1) Treat abnormal blood vessels near eyelid to close them off decrease inflammation2) Thermal treatment softens the glands and allows to discharge secretions more readilySome evidence of therapeutic potential but further studies needed1-2

1Toyos R et al Photomed Laser Surg 2015 January 1 33(1) 41ndash462Craig JP et al Invest Ophthalmol Vis Sci 2015 Feb 1256(3)1965-70 doi 101167iovs14-15764

2018

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iLuxreg Tear Film Innovationsbull Main effect unblocks Meibomian glandsbull Heat amp pressure therapybull 8-12 min treatmentbull Handheld Devicebull Glands can be viewed via magnifier

bull No clinically significant differences between iLux and LipiFlow with respect to indication for use and device performance1

1ldquo510(K) SUMMARY ndash K172645rdquo US Food amp Drug Administration Dec 2017 wwwaccessdatafdagovcdrh_docspdf17K172645pdf

2018

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BlephExreg Rysurgbull FDA clearance bull Main effect lid margin debridement bull 6-8 minute treatmentbull In-officebull Lasts three to six months before requiring a

retreatmentbull Evidence of improvement for contact lens

wearers through significant reduction in bacterial load on patientsrsquo eyelids1

1Siddireddy JS Tan-Showyin J Vijay AK Willcox M A Comfortable Eye Needs Fats Presented at the University of New South Wales Sydney Australia 2015

Rysurgcom

2018

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Blephasteamreg Laboratoires Theacuteabull Main effect warming goggles that promote fluidization Meibomian glands secretions through heat and pressure bull ESPOIR Study evidence of significant improvement in symptoms using the visual analogous scale (VAS)1

bull Expensive devicebull Need further studies with larger samples sizes

to determine efficacy2

1 Doan S Chiambaretta F Gabison EE Cochereau I Baudoin C Efficacy of heating wet chamber warming goggles (Blephasteamreg) in adult posterior blepharitis Invest Opthalmol Vis Sci 201152 E-Abstract 38332Benitez Del Castillo JM Kaercher T Mansour K Wylegala E Dua H Evaluation of the efficacy safety and acceptability of an eyelid warming device for the treatment of meibomian gland dysfunction Clin Ophthalmol 201482019ndash2027

2018

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NuLidstrade NuSight

bull Main effect lid scrub that stimulates Meibomian glands by removing biofilm and scurf that block the opening of the glands

bull Doctor-prescribed In-home treatmentbull 60 second daily treatmentbull A multi-center clinical study showed

evidence of 50 decrease in dry eye symptoms 65 improvement in TBUT and 81 improvement in Meibomian Gland liquid secretions1

1Schanzlin Olkowski Coble Gross NuLids II Study April 2018

2018

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copy 48

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TearCare System Sight Sciences

bull First wearable therapeutic eyelid therapy devicebull In-office treatmentbull 12 minute thermal eyelid treatment followed by expression forceps to

manually evacuate residual obstructionsbull Evidence from pilot study suggested improved TBUT corneal and

conjunctival staining scored and dry eye symptoms based on OSDI SPEED and SANDE1

bull Further clinical evidence underway

Badawi David A novel system TearCarereg for the treatment of the signs and symptoms of dry eye disease Clinical Ophthalmology (Auckland NZ) 12 (2018) 683

2018

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Anti-Inflammatory Pharmaceuticals

Cyclosporine

Main effectbull Anti-inflammatory therapy

bull Inhibits T-cell maturation

bull Decreases pro-inflammatory cytokines

bull Upregulates anti-inflammatory cytokines20

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Cyclosporine A cationic emulsion 01 (Ikervisreg Santen)

bull Approved in Europe in 2015bull Main effect prolonged precorneal residence time and improved

bioavailabilityo Indicated for patients with severe DED that has not improved

using tear substitutesbull Clinical evidence of reduced HLA-DR expression at 6 mo measured

through impression cytology overall greater benefits for patients with Sjoumlgrenrsquos Syndrome1

1Leonardi A Messmer EM Labetoulle M et al Efficacy and safety of 01 ciclosporin A cationic emulsion in dry eye disease a pooled analysis of two double-masked randomised vehicle-controlled phase III clinical studies Br J Ophthalmol 2018

2018

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Cyclosporine 009 (OTX-101 CequaTM Sun Pharma)

bull FDA Approval Aug 2018

bull Highest FDA-approved concentration of cyclosporine A1

bull Main effect Increase tear production

bull Calcineurin inhibitor

bull Nanomicellar formulation eases entry into corneal and conjunctival cells

bull Two multicenter studies report a statistically significant increase (ge 10 mm) in Schirmer wetting at 3 mo in patients receiving CequaTM vs vehicle1

Cyclosporine - New Preparations

Biospacecom

1epgonlineorg ldquoFDA Approves CEQUA to Treat Dry Eye Syndrome- Sun Pharma + Sun Ophthalmicsrdquo Epgonlineorg Aug 2018 wwwepgonlineorgusnewsfda-approves-cequa-to-treat-dry-eye-syndrome---sun-pharma---sun--ophthalmics-html

2018

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Cyclosporine 005 and 01 (CyclASol Novaliq)

bull Semifluorinated alkanes formulation better dissolves Cyclosporine Abull Greater penetration than FDA-approved 005 Cyclosporine A

(Restasis)bull Evidence of decreased corneal and conjunctival staining after 14

days2

bull It remains unknown whether greater concentration leads to better results phase 3 studies are underway3

2Novaliq CyclASolreg ndash Cyclosporine in SFA for Ophthalmological Application to Treat Dry Eye Syndrome 20153 Lallemand F Shmitt M Bourges JL et al Cyclosporine A delivery to the eye a comprehensive review of academic and industrial efforts Eur J Pharm Biopharm 201711714-28

2018

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Cyclosporin with chondroiton sulphate

Klarity- C

Imprimis- compounded

chondroitin sulfate

2018

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SkQ1 bull Main effects synthesized small molecule targeted to reduce oxidative stress in cellmitochondria

o Regenerates itself o SkQ1 ophthalmic solution is indicated for pathologies of the eye associated with

oxidative stress such as dry eye 1

o Approved in Russia (2011) and marketed as Visomitinbull Clinical evidence suggest statistically significant 2

o Decrease in corneal stainingo Improvements in lid margin rednesso Improvements in symptoms measuredo through Ora CalibraTM scales

1Wakamatsu TH Dogru M Tsubota K Tearful relations oxidative stress inflammation and eye diseases Arq Bras Oftalmol 200871(6 Suppl)72ndash92Petrov Anton et al SkQ1 ophthalmic solution for dry eye treatment results of a phase 2 safety and efficacy clinical study in the environment and during challenge in the controlled adverse environment model Advances in therapy 331 (2016) 96-115

2018

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Steroids- new formulation bullKPI-121- Kala Pharmaceuticals

bullMucous ndash penetrating particle ( MPP) ndashbullnano particles

bullLoteprednol -025

bull Better penetration low dose steroid

bullEpisodic flare ups of DED

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ADX-102 (Reproxalap Aldeyra Therapeutics)bull Small molecule topical agentbull Traps aldehydes that usually activate inflammatory factorsbull Positive clinical evidence of improvement in signs and

symptoms of dry eye1

Thymosin beta 4 (Tβ4 ) bull 43-amino acid G-actin binding proteinbull Downregulates transcription of inflammatory mediators and promotes corneal

epithelial cell migrationbull Phase 3 clinical trial with Tβ4 (RGN-259 RegeneRx) showed improvement in signs

and symptoms of dry eye through corneal staining tear production and expression of inflammatory factors2

1Aldehyde trap drug rapidly improves signs symptoms of dry eye disease American Academy of Ophthalmology (2017) httpswwwaaoorgheadlinealdehyde-trap-drug-rapidly-improves-signs-symptoms2Kim Chae Eun et al RGN-259 (thymosin β4) improves clinically important dry eye efficacies in comparison with prescription drugs in a dry eye model Scientific reports 81 (2018) 10500

Aldeyracom

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Tear Enhancements

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bull Currently approved in Japan and South Korea1

bull Main Effect Increase tear fluid and mucin secretion on the ocular surface through interaction with P2Y2 receptors in the conjunctiva

bull Evidence from clinical trials suggest diquafosol improves corneal staining more effectively than a comparable sodium hyaluronate solution2

Diquafosol Tetrasodium(3 Ophthalmic Solution)

1Koh Shizuka Clinical utility of 3 diquafosol ophthalmic solution in the treatment of dry eyes Clinical Ophthalmology (Auckland NZ) 9 (2015) 8652Takamura Etsuko et al A randomised double-masked comparison study of diquafosol versus sodium hyaluronate ophthalmic solutions in dry eye patients British Journal of Ophthalmology 9610 (2012) 1310-1315

Pubmedcom

Santencom

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Rebapimide

(2 Ophthalmic Solution)

bull Currently approved in Japanbull Main Effect stimulates mucin secretagogue activity in

cornea and conjunctivabull Clinical evidence suggests

o Statistically significant Improvement in corneal and conjunctival staining as well as in quality of life as well as in tear break-up time12

o Potential role in suppressing the expression of inflammatory proteins (Polyl)3

1 Kinoshita Shigeru et al Rebamipide (OPC-12759) in the treatment of dry eye a randomized double-masked multicenter placebo-controlled phase II study Ophthalmology11912 (2012) 2471-24782 Kashima Tomoyuki et al Rebamipide ophthalmic suspension for the treatment of dry eye syndrome a critical appraisal Clinical ophthalmology (Auckland NZ) 8 (2014) 10033Ueta Mayumi et al Rebamipide suppresses PolyI C-stimulated cytokine production in human conjunctival epithelial cells Journal of Ocular Pharmacology and Therapeutics 297 (2013) 688-693

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TrueTearreg Allerganbull FDA Clearancebull Main effect intranasal applicator sends

electrical currents to nerves that stimulate tear production

bull Evidence of improved Schirmer scores decreased symptoms and corneal and conjunctival staining at 6 mo Ocular comfort lasted for 3 hours following neurostimulationo Secondary effect intranasal application

promotes goblet cell mucin secretion which stabilizes the tear film1

Truetearcom

1Gumus K Schuetzle KL Pflugfelder SC Randomized controlled crossover trial comparing the impact of sham or intranasal tear neurostimulation on 654 GD Novack et al The Ocular Surface xxx (2017) 635e655 conjunctival goblet cell degranulation Am J Ophthalmol 2017177159e68

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Pharmaceutical to stimulate nerves

bullNasal Spray OC-01

bullOyster Point Pharma

bullStimulate natural tears

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Amniotic cytokine extract(Ocular Science)bullACE is a novel drop marketed as Genesis bullContains various cytokines growth factor

and anti-inflammatory moleculesbull Effective in a small pilot study

Amniotic Cytokine Extract Promising in Patients with Dry Ey Disease MDLinx

httpswwwmdlinxcomophthalmologyarticle1280 1113088 Accessed Jan 27 2018

Amniotic Cytokine Extract Promising in Patients with Dry Ey Disease MDLinx

httpswwwmdlinxcomophthalmologyarticle1280 1113088 Accessed Jan 27 2

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Recombinant human nerve growth factor (OxervateTM eye drops Dompeacute)

bull FDA Approval Aug 2018o First approved drug for Neurotropic keratitis (NK) ndashdegenerative disease with loss of corneal sensation o Topical eye drop o Clinical evidence of complete corneal healing in 70 of patients treated with Oxervate after 8 weeks1

1Bonini S et al Phase II Randomized Double-Masked Vehicle-Controlled Trial of Recombinant Human Nerve Growth Factor for Neurotrophic Keratitis Ophthalmology 125 1332ndash1343 (2018)

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Perfluorohexyloctane (NovaTears Novaliq)

bull Main effect prevent evaporative DED by increasing tear film and lipid layer thickness

bull Approved in Europe Australia and New Zealandbull Clinical evidence of increased tear production and tear film

stability as well as significant decrease in OSDI scores and in corneal staining1

1Steven P et al Semifluorinated Alkane Eye Drops for Treatment of Dry Eye Disease ndash A Prospective Multicenter Noninterventional Study J Ocul Pharmacol Ther 2015 Oct 1 31(8) 498-503

Corneal Epithelium Healing

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CrossThiolated Carboxymethyl Hyaluronic Acid Liquid-Gel

(Ocular Bandage Gel EyeGate Pharma)

bull Main effects accelerate corneal healing and reduce corneal stainingo Indicated for defects due to photorefcrative keratectomy (PRK)o Indicated for Punctate epitheliopathies (PE) associated with

dry eyebull Treatment in development July 2018 approval to conduct two

pilot studies using OBG for PE and PRKbull A first-in-human pilot study (n=39) showed accelerated corneal

reepithelialization through slit lamp examination at day 1 after PRK Further studies needed1

1Durrie Daniel S et al Ability of a new crosslinked polymer ocular bandage gel to accelerate reepithelialization after photorefractive keratectomy Journal of Cataract amp Refractive Surgery 443 (2018) 369-375

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Biologic MoleculesDry Eye Assessment

bull Proteoglycan-4 (Lubricin)oRecently discovered on the ocular surface in the meibomian glands2

oFunctions to prevent friction at the cornea-lid interface and has anti-inflammatory propertiesoCommercial lubricin-based lubricants remain scarceoEvidence from clinical studies with recombinant human lubricin suggest

significant improvement in signs and symptoms of DED through TBUT corneal staining and eyelid and conjunctival redness3

1De Paiva CS Chotikavanich S Pangelinan SB Pitcher 3rd JD Fang B Zheng X et al IL-17 disrupts corneal barrier following desiccating stress Mucosal Immunol 20092(3)243ndash2532Iqbal SM Leonard C Regmi SC De Rantere D Tailor P Ren G et al LubricinProteoglycan 4 binds to and regulates the activity of Toll-Like Receptors In Vitro Sci Rep20166189103Lambiase A Sullivan BD Schmidt TA Sullivan DA Jay GD Truitt ER et al A Two-Week Randomized Double-masked Study to Evaluate Safety and Efficacy of Lubricin

(150 mugmL) Eye Drops Versus Sodium Hyaluronate (HA) 018 Eye Drops (Vismed(R)) in Patients with Moderate Dry Eye Disease Ocul Surf 20171577ndash87

2018

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Why Ocular Biomarkers

Surrogate Endpoints- None accepted by the FDA or Europe to date Validation needed- clear clinical relevance

Enrichment of Study Population Still regulatory hurdles

Support mechanism of action of treatment Topical ciclosporin in Europe for Dry eyes (Europe2015 Ikervis)1

SEGMENT THE DRY EYE POPULATION- TREAT MORE SPECIFICALLY-PERSONALIZE TREATMENT

1 Ikervis SmPC June 2015 available at httpswwwmedicinesorgukemcmedicine30584

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Meibomian Gland Dysfunction - Treatments

Heating amp Pressure Devices

bull Lipiflow

bull Intense Pulsed Light (IPL)

bull iLux

bull Blephex

bull NuLids

bull Blephasteam

2018

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LipiFlowreg TearScience

bull FDA clearancebull Thermal pulsation Devicebull 12 minute treatmentbull Delivers heat to the inner eyelid and massage to the outside unblock the flow of lipids from the meibomian glandsbull Preliminary evidence At 3 months-1 year follow-up improved symptoms and signs (secretions TBUT)1-5

1Lane SS et al Cornea 2012 Apr31(4)396-4042Greiner JV Curr Eye Res 2012 Apr37(4)272-83Greiner JV Clin Experiment Ophthalmol 2013 Aug41(6)524-304Finis D et al Ocul Surf 2014 Apr12(2)146-545Finis D et al Cornea 2014 Dec33(12)1265-70

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Intense Pulsed Light (IPL) Lumenis or E-eyeMain effect lower eyelidsHypothesized mechanism of action1) Treat abnormal blood vessels near eyelid to close them off decrease inflammation2) Thermal treatment softens the glands and allows to discharge secretions more readilySome evidence of therapeutic potential but further studies needed1-2

1Toyos R et al Photomed Laser Surg 2015 January 1 33(1) 41ndash462Craig JP et al Invest Ophthalmol Vis Sci 2015 Feb 1256(3)1965-70 doi 101167iovs14-15764

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iLuxreg Tear Film Innovationsbull Main effect unblocks Meibomian glandsbull Heat amp pressure therapybull 8-12 min treatmentbull Handheld Devicebull Glands can be viewed via magnifier

bull No clinically significant differences between iLux and LipiFlow with respect to indication for use and device performance1

1ldquo510(K) SUMMARY ndash K172645rdquo US Food amp Drug Administration Dec 2017 wwwaccessdatafdagovcdrh_docspdf17K172645pdf

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BlephExreg Rysurgbull FDA clearance bull Main effect lid margin debridement bull 6-8 minute treatmentbull In-officebull Lasts three to six months before requiring a

retreatmentbull Evidence of improvement for contact lens

wearers through significant reduction in bacterial load on patientsrsquo eyelids1

1Siddireddy JS Tan-Showyin J Vijay AK Willcox M A Comfortable Eye Needs Fats Presented at the University of New South Wales Sydney Australia 2015

Rysurgcom

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Blephasteamreg Laboratoires Theacuteabull Main effect warming goggles that promote fluidization Meibomian glands secretions through heat and pressure bull ESPOIR Study evidence of significant improvement in symptoms using the visual analogous scale (VAS)1

bull Expensive devicebull Need further studies with larger samples sizes

to determine efficacy2

1 Doan S Chiambaretta F Gabison EE Cochereau I Baudoin C Efficacy of heating wet chamber warming goggles (Blephasteamreg) in adult posterior blepharitis Invest Opthalmol Vis Sci 201152 E-Abstract 38332Benitez Del Castillo JM Kaercher T Mansour K Wylegala E Dua H Evaluation of the efficacy safety and acceptability of an eyelid warming device for the treatment of meibomian gland dysfunction Clin Ophthalmol 201482019ndash2027

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NuLidstrade NuSight

bull Main effect lid scrub that stimulates Meibomian glands by removing biofilm and scurf that block the opening of the glands

bull Doctor-prescribed In-home treatmentbull 60 second daily treatmentbull A multi-center clinical study showed

evidence of 50 decrease in dry eye symptoms 65 improvement in TBUT and 81 improvement in Meibomian Gland liquid secretions1

1Schanzlin Olkowski Coble Gross NuLids II Study April 2018

2018

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TearCare System Sight Sciences

bull First wearable therapeutic eyelid therapy devicebull In-office treatmentbull 12 minute thermal eyelid treatment followed by expression forceps to

manually evacuate residual obstructionsbull Evidence from pilot study suggested improved TBUT corneal and

conjunctival staining scored and dry eye symptoms based on OSDI SPEED and SANDE1

bull Further clinical evidence underway

Badawi David A novel system TearCarereg for the treatment of the signs and symptoms of dry eye disease Clinical Ophthalmology (Auckland NZ) 12 (2018) 683

2018

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Anti-Inflammatory Pharmaceuticals

Cyclosporine

Main effectbull Anti-inflammatory therapy

bull Inhibits T-cell maturation

bull Decreases pro-inflammatory cytokines

bull Upregulates anti-inflammatory cytokines20

18 copy

48th

Europ

ean C

ontac

t Len

s Soc

iety O

f Oph

thalm

ologis

ts A

ll righ

ts re

serve

d - A

ny re

prod

uctio

n eve

n in p

art is

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ibited

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Cyclosporine A cationic emulsion 01 (Ikervisreg Santen)

bull Approved in Europe in 2015bull Main effect prolonged precorneal residence time and improved

bioavailabilityo Indicated for patients with severe DED that has not improved

using tear substitutesbull Clinical evidence of reduced HLA-DR expression at 6 mo measured

through impression cytology overall greater benefits for patients with Sjoumlgrenrsquos Syndrome1

1Leonardi A Messmer EM Labetoulle M et al Efficacy and safety of 01 ciclosporin A cationic emulsion in dry eye disease a pooled analysis of two double-masked randomised vehicle-controlled phase III clinical studies Br J Ophthalmol 2018

2018

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Cyclosporine 009 (OTX-101 CequaTM Sun Pharma)

bull FDA Approval Aug 2018

bull Highest FDA-approved concentration of cyclosporine A1

bull Main effect Increase tear production

bull Calcineurin inhibitor

bull Nanomicellar formulation eases entry into corneal and conjunctival cells

bull Two multicenter studies report a statistically significant increase (ge 10 mm) in Schirmer wetting at 3 mo in patients receiving CequaTM vs vehicle1

Cyclosporine - New Preparations

Biospacecom

1epgonlineorg ldquoFDA Approves CEQUA to Treat Dry Eye Syndrome- Sun Pharma + Sun Ophthalmicsrdquo Epgonlineorg Aug 2018 wwwepgonlineorgusnewsfda-approves-cequa-to-treat-dry-eye-syndrome---sun-pharma---sun--ophthalmics-html

2018

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Cyclosporine 005 and 01 (CyclASol Novaliq)

bull Semifluorinated alkanes formulation better dissolves Cyclosporine Abull Greater penetration than FDA-approved 005 Cyclosporine A

(Restasis)bull Evidence of decreased corneal and conjunctival staining after 14

days2

bull It remains unknown whether greater concentration leads to better results phase 3 studies are underway3

2Novaliq CyclASolreg ndash Cyclosporine in SFA for Ophthalmological Application to Treat Dry Eye Syndrome 20153 Lallemand F Shmitt M Bourges JL et al Cyclosporine A delivery to the eye a comprehensive review of academic and industrial efforts Eur J Pharm Biopharm 201711714-28

2018

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Cyclosporin with chondroiton sulphate

Klarity- C

Imprimis- compounded

chondroitin sulfate

2018

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2018

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SkQ1 bull Main effects synthesized small molecule targeted to reduce oxidative stress in cellmitochondria

o Regenerates itself o SkQ1 ophthalmic solution is indicated for pathologies of the eye associated with

oxidative stress such as dry eye 1

o Approved in Russia (2011) and marketed as Visomitinbull Clinical evidence suggest statistically significant 2

o Decrease in corneal stainingo Improvements in lid margin rednesso Improvements in symptoms measuredo through Ora CalibraTM scales

1Wakamatsu TH Dogru M Tsubota K Tearful relations oxidative stress inflammation and eye diseases Arq Bras Oftalmol 200871(6 Suppl)72ndash92Petrov Anton et al SkQ1 ophthalmic solution for dry eye treatment results of a phase 2 safety and efficacy clinical study in the environment and during challenge in the controlled adverse environment model Advances in therapy 331 (2016) 96-115

2018

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Steroids- new formulation bullKPI-121- Kala Pharmaceuticals

bullMucous ndash penetrating particle ( MPP) ndashbullnano particles

bullLoteprednol -025

bull Better penetration low dose steroid

bullEpisodic flare ups of DED

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ADX-102 (Reproxalap Aldeyra Therapeutics)bull Small molecule topical agentbull Traps aldehydes that usually activate inflammatory factorsbull Positive clinical evidence of improvement in signs and

symptoms of dry eye1

Thymosin beta 4 (Tβ4 ) bull 43-amino acid G-actin binding proteinbull Downregulates transcription of inflammatory mediators and promotes corneal

epithelial cell migrationbull Phase 3 clinical trial with Tβ4 (RGN-259 RegeneRx) showed improvement in signs

and symptoms of dry eye through corneal staining tear production and expression of inflammatory factors2

1Aldehyde trap drug rapidly improves signs symptoms of dry eye disease American Academy of Ophthalmology (2017) httpswwwaaoorgheadlinealdehyde-trap-drug-rapidly-improves-signs-symptoms2Kim Chae Eun et al RGN-259 (thymosin β4) improves clinically important dry eye efficacies in comparison with prescription drugs in a dry eye model Scientific reports 81 (2018) 10500

Aldeyracom

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Tear Enhancements

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bull Currently approved in Japan and South Korea1

bull Main Effect Increase tear fluid and mucin secretion on the ocular surface through interaction with P2Y2 receptors in the conjunctiva

bull Evidence from clinical trials suggest diquafosol improves corneal staining more effectively than a comparable sodium hyaluronate solution2

Diquafosol Tetrasodium(3 Ophthalmic Solution)

1Koh Shizuka Clinical utility of 3 diquafosol ophthalmic solution in the treatment of dry eyes Clinical Ophthalmology (Auckland NZ) 9 (2015) 8652Takamura Etsuko et al A randomised double-masked comparison study of diquafosol versus sodium hyaluronate ophthalmic solutions in dry eye patients British Journal of Ophthalmology 9610 (2012) 1310-1315

Pubmedcom

Santencom

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Rebapimide

(2 Ophthalmic Solution)

bull Currently approved in Japanbull Main Effect stimulates mucin secretagogue activity in

cornea and conjunctivabull Clinical evidence suggests

o Statistically significant Improvement in corneal and conjunctival staining as well as in quality of life as well as in tear break-up time12

o Potential role in suppressing the expression of inflammatory proteins (Polyl)3

1 Kinoshita Shigeru et al Rebamipide (OPC-12759) in the treatment of dry eye a randomized double-masked multicenter placebo-controlled phase II study Ophthalmology11912 (2012) 2471-24782 Kashima Tomoyuki et al Rebamipide ophthalmic suspension for the treatment of dry eye syndrome a critical appraisal Clinical ophthalmology (Auckland NZ) 8 (2014) 10033Ueta Mayumi et al Rebamipide suppresses PolyI C-stimulated cytokine production in human conjunctival epithelial cells Journal of Ocular Pharmacology and Therapeutics 297 (2013) 688-693

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TrueTearreg Allerganbull FDA Clearancebull Main effect intranasal applicator sends

electrical currents to nerves that stimulate tear production

bull Evidence of improved Schirmer scores decreased symptoms and corneal and conjunctival staining at 6 mo Ocular comfort lasted for 3 hours following neurostimulationo Secondary effect intranasal application

promotes goblet cell mucin secretion which stabilizes the tear film1

Truetearcom

1Gumus K Schuetzle KL Pflugfelder SC Randomized controlled crossover trial comparing the impact of sham or intranasal tear neurostimulation on 654 GD Novack et al The Ocular Surface xxx (2017) 635e655 conjunctival goblet cell degranulation Am J Ophthalmol 2017177159e68

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Pharmaceutical to stimulate nerves

bullNasal Spray OC-01

bullOyster Point Pharma

bullStimulate natural tears

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Amniotic cytokine extract(Ocular Science)bullACE is a novel drop marketed as Genesis bullContains various cytokines growth factor

and anti-inflammatory moleculesbull Effective in a small pilot study

Amniotic Cytokine Extract Promising in Patients with Dry Ey Disease MDLinx

httpswwwmdlinxcomophthalmologyarticle1280 1113088 Accessed Jan 27 2018

Amniotic Cytokine Extract Promising in Patients with Dry Ey Disease MDLinx

httpswwwmdlinxcomophthalmologyarticle1280 1113088 Accessed Jan 27 2

2018

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Recombinant human nerve growth factor (OxervateTM eye drops Dompeacute)

bull FDA Approval Aug 2018o First approved drug for Neurotropic keratitis (NK) ndashdegenerative disease with loss of corneal sensation o Topical eye drop o Clinical evidence of complete corneal healing in 70 of patients treated with Oxervate after 8 weeks1

1Bonini S et al Phase II Randomized Double-Masked Vehicle-Controlled Trial of Recombinant Human Nerve Growth Factor for Neurotrophic Keratitis Ophthalmology 125 1332ndash1343 (2018)

2018

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Perfluorohexyloctane (NovaTears Novaliq)

bull Main effect prevent evaporative DED by increasing tear film and lipid layer thickness

bull Approved in Europe Australia and New Zealandbull Clinical evidence of increased tear production and tear film

stability as well as significant decrease in OSDI scores and in corneal staining1

1Steven P et al Semifluorinated Alkane Eye Drops for Treatment of Dry Eye Disease ndash A Prospective Multicenter Noninterventional Study J Ocul Pharmacol Ther 2015 Oct 1 31(8) 498-503

Corneal Epithelium Healing

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CrossThiolated Carboxymethyl Hyaluronic Acid Liquid-Gel

(Ocular Bandage Gel EyeGate Pharma)

bull Main effects accelerate corneal healing and reduce corneal stainingo Indicated for defects due to photorefcrative keratectomy (PRK)o Indicated for Punctate epitheliopathies (PE) associated with

dry eyebull Treatment in development July 2018 approval to conduct two

pilot studies using OBG for PE and PRKbull A first-in-human pilot study (n=39) showed accelerated corneal

reepithelialization through slit lamp examination at day 1 after PRK Further studies needed1

1Durrie Daniel S et al Ability of a new crosslinked polymer ocular bandage gel to accelerate reepithelialization after photorefractive keratectomy Journal of Cataract amp Refractive Surgery 443 (2018) 369-375

2018

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Biologic MoleculesDry Eye Assessment

bull Proteoglycan-4 (Lubricin)oRecently discovered on the ocular surface in the meibomian glands2

oFunctions to prevent friction at the cornea-lid interface and has anti-inflammatory propertiesoCommercial lubricin-based lubricants remain scarceoEvidence from clinical studies with recombinant human lubricin suggest

significant improvement in signs and symptoms of DED through TBUT corneal staining and eyelid and conjunctival redness3

1De Paiva CS Chotikavanich S Pangelinan SB Pitcher 3rd JD Fang B Zheng X et al IL-17 disrupts corneal barrier following desiccating stress Mucosal Immunol 20092(3)243ndash2532Iqbal SM Leonard C Regmi SC De Rantere D Tailor P Ren G et al LubricinProteoglycan 4 binds to and regulates the activity of Toll-Like Receptors In Vitro Sci Rep20166189103Lambiase A Sullivan BD Schmidt TA Sullivan DA Jay GD Truitt ER et al A Two-Week Randomized Double-masked Study to Evaluate Safety and Efficacy of Lubricin

(150 mugmL) Eye Drops Versus Sodium Hyaluronate (HA) 018 Eye Drops (Vismed(R)) in Patients with Moderate Dry Eye Disease Ocul Surf 20171577ndash87

2018

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Why Ocular Biomarkers

Surrogate Endpoints- None accepted by the FDA or Europe to date Validation needed- clear clinical relevance

Enrichment of Study Population Still regulatory hurdles

Support mechanism of action of treatment Topical ciclosporin in Europe for Dry eyes (Europe2015 Ikervis)1

SEGMENT THE DRY EYE POPULATION- TREAT MORE SPECIFICALLY-PERSONALIZE TREATMENT

1 Ikervis SmPC June 2015 available at httpswwwmedicinesorgukemcmedicine30584

2018

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LipiFlowreg TearScience

bull FDA clearancebull Thermal pulsation Devicebull 12 minute treatmentbull Delivers heat to the inner eyelid and massage to the outside unblock the flow of lipids from the meibomian glandsbull Preliminary evidence At 3 months-1 year follow-up improved symptoms and signs (secretions TBUT)1-5

1Lane SS et al Cornea 2012 Apr31(4)396-4042Greiner JV Curr Eye Res 2012 Apr37(4)272-83Greiner JV Clin Experiment Ophthalmol 2013 Aug41(6)524-304Finis D et al Ocul Surf 2014 Apr12(2)146-545Finis D et al Cornea 2014 Dec33(12)1265-70

2018

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Intense Pulsed Light (IPL) Lumenis or E-eyeMain effect lower eyelidsHypothesized mechanism of action1) Treat abnormal blood vessels near eyelid to close them off decrease inflammation2) Thermal treatment softens the glands and allows to discharge secretions more readilySome evidence of therapeutic potential but further studies needed1-2

1Toyos R et al Photomed Laser Surg 2015 January 1 33(1) 41ndash462Craig JP et al Invest Ophthalmol Vis Sci 2015 Feb 1256(3)1965-70 doi 101167iovs14-15764

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iLuxreg Tear Film Innovationsbull Main effect unblocks Meibomian glandsbull Heat amp pressure therapybull 8-12 min treatmentbull Handheld Devicebull Glands can be viewed via magnifier

bull No clinically significant differences between iLux and LipiFlow with respect to indication for use and device performance1

1ldquo510(K) SUMMARY ndash K172645rdquo US Food amp Drug Administration Dec 2017 wwwaccessdatafdagovcdrh_docspdf17K172645pdf

2018

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BlephExreg Rysurgbull FDA clearance bull Main effect lid margin debridement bull 6-8 minute treatmentbull In-officebull Lasts three to six months before requiring a

retreatmentbull Evidence of improvement for contact lens

wearers through significant reduction in bacterial load on patientsrsquo eyelids1

1Siddireddy JS Tan-Showyin J Vijay AK Willcox M A Comfortable Eye Needs Fats Presented at the University of New South Wales Sydney Australia 2015

Rysurgcom

2018

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Blephasteamreg Laboratoires Theacuteabull Main effect warming goggles that promote fluidization Meibomian glands secretions through heat and pressure bull ESPOIR Study evidence of significant improvement in symptoms using the visual analogous scale (VAS)1

bull Expensive devicebull Need further studies with larger samples sizes

to determine efficacy2

1 Doan S Chiambaretta F Gabison EE Cochereau I Baudoin C Efficacy of heating wet chamber warming goggles (Blephasteamreg) in adult posterior blepharitis Invest Opthalmol Vis Sci 201152 E-Abstract 38332Benitez Del Castillo JM Kaercher T Mansour K Wylegala E Dua H Evaluation of the efficacy safety and acceptability of an eyelid warming device for the treatment of meibomian gland dysfunction Clin Ophthalmol 201482019ndash2027

2018

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NuLidstrade NuSight

bull Main effect lid scrub that stimulates Meibomian glands by removing biofilm and scurf that block the opening of the glands

bull Doctor-prescribed In-home treatmentbull 60 second daily treatmentbull A multi-center clinical study showed

evidence of 50 decrease in dry eye symptoms 65 improvement in TBUT and 81 improvement in Meibomian Gland liquid secretions1

1Schanzlin Olkowski Coble Gross NuLids II Study April 2018

2018

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TearCare System Sight Sciences

bull First wearable therapeutic eyelid therapy devicebull In-office treatmentbull 12 minute thermal eyelid treatment followed by expression forceps to

manually evacuate residual obstructionsbull Evidence from pilot study suggested improved TBUT corneal and

conjunctival staining scored and dry eye symptoms based on OSDI SPEED and SANDE1

bull Further clinical evidence underway

Badawi David A novel system TearCarereg for the treatment of the signs and symptoms of dry eye disease Clinical Ophthalmology (Auckland NZ) 12 (2018) 683

2018

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Anti-Inflammatory Pharmaceuticals

Cyclosporine

Main effectbull Anti-inflammatory therapy

bull Inhibits T-cell maturation

bull Decreases pro-inflammatory cytokines

bull Upregulates anti-inflammatory cytokines20

18 copy

48th

Europ

ean C

ontac

t Len

s Soc

iety O

f Oph

thalm

ologis

ts A

ll righ

ts re

serve

d - A

ny re

prod

uctio

n eve

n in p

art is

proh

ibited

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Cyclosporine A cationic emulsion 01 (Ikervisreg Santen)

bull Approved in Europe in 2015bull Main effect prolonged precorneal residence time and improved

bioavailabilityo Indicated for patients with severe DED that has not improved

using tear substitutesbull Clinical evidence of reduced HLA-DR expression at 6 mo measured

through impression cytology overall greater benefits for patients with Sjoumlgrenrsquos Syndrome1

1Leonardi A Messmer EM Labetoulle M et al Efficacy and safety of 01 ciclosporin A cationic emulsion in dry eye disease a pooled analysis of two double-masked randomised vehicle-controlled phase III clinical studies Br J Ophthalmol 2018

2018

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Cyclosporine 009 (OTX-101 CequaTM Sun Pharma)

bull FDA Approval Aug 2018

bull Highest FDA-approved concentration of cyclosporine A1

bull Main effect Increase tear production

bull Calcineurin inhibitor

bull Nanomicellar formulation eases entry into corneal and conjunctival cells

bull Two multicenter studies report a statistically significant increase (ge 10 mm) in Schirmer wetting at 3 mo in patients receiving CequaTM vs vehicle1

Cyclosporine - New Preparations

Biospacecom

1epgonlineorg ldquoFDA Approves CEQUA to Treat Dry Eye Syndrome- Sun Pharma + Sun Ophthalmicsrdquo Epgonlineorg Aug 2018 wwwepgonlineorgusnewsfda-approves-cequa-to-treat-dry-eye-syndrome---sun-pharma---sun--ophthalmics-html

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Cyclosporine 005 and 01 (CyclASol Novaliq)

bull Semifluorinated alkanes formulation better dissolves Cyclosporine Abull Greater penetration than FDA-approved 005 Cyclosporine A

(Restasis)bull Evidence of decreased corneal and conjunctival staining after 14

days2

bull It remains unknown whether greater concentration leads to better results phase 3 studies are underway3

2Novaliq CyclASolreg ndash Cyclosporine in SFA for Ophthalmological Application to Treat Dry Eye Syndrome 20153 Lallemand F Shmitt M Bourges JL et al Cyclosporine A delivery to the eye a comprehensive review of academic and industrial efforts Eur J Pharm Biopharm 201711714-28

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Cyclosporin with chondroiton sulphate

Klarity- C

Imprimis- compounded

chondroitin sulfate

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SkQ1 bull Main effects synthesized small molecule targeted to reduce oxidative stress in cellmitochondria

o Regenerates itself o SkQ1 ophthalmic solution is indicated for pathologies of the eye associated with

oxidative stress such as dry eye 1

o Approved in Russia (2011) and marketed as Visomitinbull Clinical evidence suggest statistically significant 2

o Decrease in corneal stainingo Improvements in lid margin rednesso Improvements in symptoms measuredo through Ora CalibraTM scales

1Wakamatsu TH Dogru M Tsubota K Tearful relations oxidative stress inflammation and eye diseases Arq Bras Oftalmol 200871(6 Suppl)72ndash92Petrov Anton et al SkQ1 ophthalmic solution for dry eye treatment results of a phase 2 safety and efficacy clinical study in the environment and during challenge in the controlled adverse environment model Advances in therapy 331 (2016) 96-115

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Steroids- new formulation bullKPI-121- Kala Pharmaceuticals

bullMucous ndash penetrating particle ( MPP) ndashbullnano particles

bullLoteprednol -025

bull Better penetration low dose steroid

bullEpisodic flare ups of DED

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ADX-102 (Reproxalap Aldeyra Therapeutics)bull Small molecule topical agentbull Traps aldehydes that usually activate inflammatory factorsbull Positive clinical evidence of improvement in signs and

symptoms of dry eye1

Thymosin beta 4 (Tβ4 ) bull 43-amino acid G-actin binding proteinbull Downregulates transcription of inflammatory mediators and promotes corneal

epithelial cell migrationbull Phase 3 clinical trial with Tβ4 (RGN-259 RegeneRx) showed improvement in signs

and symptoms of dry eye through corneal staining tear production and expression of inflammatory factors2

1Aldehyde trap drug rapidly improves signs symptoms of dry eye disease American Academy of Ophthalmology (2017) httpswwwaaoorgheadlinealdehyde-trap-drug-rapidly-improves-signs-symptoms2Kim Chae Eun et al RGN-259 (thymosin β4) improves clinically important dry eye efficacies in comparison with prescription drugs in a dry eye model Scientific reports 81 (2018) 10500

Aldeyracom

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Tear Enhancements

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bull Currently approved in Japan and South Korea1

bull Main Effect Increase tear fluid and mucin secretion on the ocular surface through interaction with P2Y2 receptors in the conjunctiva

bull Evidence from clinical trials suggest diquafosol improves corneal staining more effectively than a comparable sodium hyaluronate solution2

Diquafosol Tetrasodium(3 Ophthalmic Solution)

1Koh Shizuka Clinical utility of 3 diquafosol ophthalmic solution in the treatment of dry eyes Clinical Ophthalmology (Auckland NZ) 9 (2015) 8652Takamura Etsuko et al A randomised double-masked comparison study of diquafosol versus sodium hyaluronate ophthalmic solutions in dry eye patients British Journal of Ophthalmology 9610 (2012) 1310-1315

Pubmedcom

Santencom

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Rebapimide

(2 Ophthalmic Solution)

bull Currently approved in Japanbull Main Effect stimulates mucin secretagogue activity in

cornea and conjunctivabull Clinical evidence suggests

o Statistically significant Improvement in corneal and conjunctival staining as well as in quality of life as well as in tear break-up time12

o Potential role in suppressing the expression of inflammatory proteins (Polyl)3

1 Kinoshita Shigeru et al Rebamipide (OPC-12759) in the treatment of dry eye a randomized double-masked multicenter placebo-controlled phase II study Ophthalmology11912 (2012) 2471-24782 Kashima Tomoyuki et al Rebamipide ophthalmic suspension for the treatment of dry eye syndrome a critical appraisal Clinical ophthalmology (Auckland NZ) 8 (2014) 10033Ueta Mayumi et al Rebamipide suppresses PolyI C-stimulated cytokine production in human conjunctival epithelial cells Journal of Ocular Pharmacology and Therapeutics 297 (2013) 688-693

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TrueTearreg Allerganbull FDA Clearancebull Main effect intranasal applicator sends

electrical currents to nerves that stimulate tear production

bull Evidence of improved Schirmer scores decreased symptoms and corneal and conjunctival staining at 6 mo Ocular comfort lasted for 3 hours following neurostimulationo Secondary effect intranasal application

promotes goblet cell mucin secretion which stabilizes the tear film1

Truetearcom

1Gumus K Schuetzle KL Pflugfelder SC Randomized controlled crossover trial comparing the impact of sham or intranasal tear neurostimulation on 654 GD Novack et al The Ocular Surface xxx (2017) 635e655 conjunctival goblet cell degranulation Am J Ophthalmol 2017177159e68

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Pharmaceutical to stimulate nerves

bullNasal Spray OC-01

bullOyster Point Pharma

bullStimulate natural tears

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Amniotic cytokine extract(Ocular Science)bullACE is a novel drop marketed as Genesis bullContains various cytokines growth factor

and anti-inflammatory moleculesbull Effective in a small pilot study

Amniotic Cytokine Extract Promising in Patients with Dry Ey Disease MDLinx

httpswwwmdlinxcomophthalmologyarticle1280 1113088 Accessed Jan 27 2018

Amniotic Cytokine Extract Promising in Patients with Dry Ey Disease MDLinx

httpswwwmdlinxcomophthalmologyarticle1280 1113088 Accessed Jan 27 2

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Recombinant human nerve growth factor (OxervateTM eye drops Dompeacute)

bull FDA Approval Aug 2018o First approved drug for Neurotropic keratitis (NK) ndashdegenerative disease with loss of corneal sensation o Topical eye drop o Clinical evidence of complete corneal healing in 70 of patients treated with Oxervate after 8 weeks1

1Bonini S et al Phase II Randomized Double-Masked Vehicle-Controlled Trial of Recombinant Human Nerve Growth Factor for Neurotrophic Keratitis Ophthalmology 125 1332ndash1343 (2018)

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Perfluorohexyloctane (NovaTears Novaliq)

bull Main effect prevent evaporative DED by increasing tear film and lipid layer thickness

bull Approved in Europe Australia and New Zealandbull Clinical evidence of increased tear production and tear film

stability as well as significant decrease in OSDI scores and in corneal staining1

1Steven P et al Semifluorinated Alkane Eye Drops for Treatment of Dry Eye Disease ndash A Prospective Multicenter Noninterventional Study J Ocul Pharmacol Ther 2015 Oct 1 31(8) 498-503

Corneal Epithelium Healing

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CrossThiolated Carboxymethyl Hyaluronic Acid Liquid-Gel

(Ocular Bandage Gel EyeGate Pharma)

bull Main effects accelerate corneal healing and reduce corneal stainingo Indicated for defects due to photorefcrative keratectomy (PRK)o Indicated for Punctate epitheliopathies (PE) associated with

dry eyebull Treatment in development July 2018 approval to conduct two

pilot studies using OBG for PE and PRKbull A first-in-human pilot study (n=39) showed accelerated corneal

reepithelialization through slit lamp examination at day 1 after PRK Further studies needed1

1Durrie Daniel S et al Ability of a new crosslinked polymer ocular bandage gel to accelerate reepithelialization after photorefractive keratectomy Journal of Cataract amp Refractive Surgery 443 (2018) 369-375

2018

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Biologic MoleculesDry Eye Assessment

bull Proteoglycan-4 (Lubricin)oRecently discovered on the ocular surface in the meibomian glands2

oFunctions to prevent friction at the cornea-lid interface and has anti-inflammatory propertiesoCommercial lubricin-based lubricants remain scarceoEvidence from clinical studies with recombinant human lubricin suggest

significant improvement in signs and symptoms of DED through TBUT corneal staining and eyelid and conjunctival redness3

1De Paiva CS Chotikavanich S Pangelinan SB Pitcher 3rd JD Fang B Zheng X et al IL-17 disrupts corneal barrier following desiccating stress Mucosal Immunol 20092(3)243ndash2532Iqbal SM Leonard C Regmi SC De Rantere D Tailor P Ren G et al LubricinProteoglycan 4 binds to and regulates the activity of Toll-Like Receptors In Vitro Sci Rep20166189103Lambiase A Sullivan BD Schmidt TA Sullivan DA Jay GD Truitt ER et al A Two-Week Randomized Double-masked Study to Evaluate Safety and Efficacy of Lubricin

(150 mugmL) Eye Drops Versus Sodium Hyaluronate (HA) 018 Eye Drops (Vismed(R)) in Patients with Moderate Dry Eye Disease Ocul Surf 20171577ndash87

2018

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Why Ocular Biomarkers

Surrogate Endpoints- None accepted by the FDA or Europe to date Validation needed- clear clinical relevance

Enrichment of Study Population Still regulatory hurdles

Support mechanism of action of treatment Topical ciclosporin in Europe for Dry eyes (Europe2015 Ikervis)1

SEGMENT THE DRY EYE POPULATION- TREAT MORE SPECIFICALLY-PERSONALIZE TREATMENT

1 Ikervis SmPC June 2015 available at httpswwwmedicinesorgukemcmedicine30584

2018

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Intense Pulsed Light (IPL) Lumenis or E-eyeMain effect lower eyelidsHypothesized mechanism of action1) Treat abnormal blood vessels near eyelid to close them off decrease inflammation2) Thermal treatment softens the glands and allows to discharge secretions more readilySome evidence of therapeutic potential but further studies needed1-2

1Toyos R et al Photomed Laser Surg 2015 January 1 33(1) 41ndash462Craig JP et al Invest Ophthalmol Vis Sci 2015 Feb 1256(3)1965-70 doi 101167iovs14-15764

2018

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iLuxreg Tear Film Innovationsbull Main effect unblocks Meibomian glandsbull Heat amp pressure therapybull 8-12 min treatmentbull Handheld Devicebull Glands can be viewed via magnifier

bull No clinically significant differences between iLux and LipiFlow with respect to indication for use and device performance1

1ldquo510(K) SUMMARY ndash K172645rdquo US Food amp Drug Administration Dec 2017 wwwaccessdatafdagovcdrh_docspdf17K172645pdf

2018

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BlephExreg Rysurgbull FDA clearance bull Main effect lid margin debridement bull 6-8 minute treatmentbull In-officebull Lasts three to six months before requiring a

retreatmentbull Evidence of improvement for contact lens

wearers through significant reduction in bacterial load on patientsrsquo eyelids1

1Siddireddy JS Tan-Showyin J Vijay AK Willcox M A Comfortable Eye Needs Fats Presented at the University of New South Wales Sydney Australia 2015

Rysurgcom

2018

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Blephasteamreg Laboratoires Theacuteabull Main effect warming goggles that promote fluidization Meibomian glands secretions through heat and pressure bull ESPOIR Study evidence of significant improvement in symptoms using the visual analogous scale (VAS)1

bull Expensive devicebull Need further studies with larger samples sizes

to determine efficacy2

1 Doan S Chiambaretta F Gabison EE Cochereau I Baudoin C Efficacy of heating wet chamber warming goggles (Blephasteamreg) in adult posterior blepharitis Invest Opthalmol Vis Sci 201152 E-Abstract 38332Benitez Del Castillo JM Kaercher T Mansour K Wylegala E Dua H Evaluation of the efficacy safety and acceptability of an eyelid warming device for the treatment of meibomian gland dysfunction Clin Ophthalmol 201482019ndash2027

2018

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NuLidstrade NuSight

bull Main effect lid scrub that stimulates Meibomian glands by removing biofilm and scurf that block the opening of the glands

bull Doctor-prescribed In-home treatmentbull 60 second daily treatmentbull A multi-center clinical study showed

evidence of 50 decrease in dry eye symptoms 65 improvement in TBUT and 81 improvement in Meibomian Gland liquid secretions1

1Schanzlin Olkowski Coble Gross NuLids II Study April 2018

2018

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TearCare System Sight Sciences

bull First wearable therapeutic eyelid therapy devicebull In-office treatmentbull 12 minute thermal eyelid treatment followed by expression forceps to

manually evacuate residual obstructionsbull Evidence from pilot study suggested improved TBUT corneal and

conjunctival staining scored and dry eye symptoms based on OSDI SPEED and SANDE1

bull Further clinical evidence underway

Badawi David A novel system TearCarereg for the treatment of the signs and symptoms of dry eye disease Clinical Ophthalmology (Auckland NZ) 12 (2018) 683

2018

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Anti-Inflammatory Pharmaceuticals

Cyclosporine

Main effectbull Anti-inflammatory therapy

bull Inhibits T-cell maturation

bull Decreases pro-inflammatory cytokines

bull Upregulates anti-inflammatory cytokines20

18 copy

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Cyclosporine A cationic emulsion 01 (Ikervisreg Santen)

bull Approved in Europe in 2015bull Main effect prolonged precorneal residence time and improved

bioavailabilityo Indicated for patients with severe DED that has not improved

using tear substitutesbull Clinical evidence of reduced HLA-DR expression at 6 mo measured

through impression cytology overall greater benefits for patients with Sjoumlgrenrsquos Syndrome1

1Leonardi A Messmer EM Labetoulle M et al Efficacy and safety of 01 ciclosporin A cationic emulsion in dry eye disease a pooled analysis of two double-masked randomised vehicle-controlled phase III clinical studies Br J Ophthalmol 2018

2018

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Cyclosporine 009 (OTX-101 CequaTM Sun Pharma)

bull FDA Approval Aug 2018

bull Highest FDA-approved concentration of cyclosporine A1

bull Main effect Increase tear production

bull Calcineurin inhibitor

bull Nanomicellar formulation eases entry into corneal and conjunctival cells

bull Two multicenter studies report a statistically significant increase (ge 10 mm) in Schirmer wetting at 3 mo in patients receiving CequaTM vs vehicle1

Cyclosporine - New Preparations

Biospacecom

1epgonlineorg ldquoFDA Approves CEQUA to Treat Dry Eye Syndrome- Sun Pharma + Sun Ophthalmicsrdquo Epgonlineorg Aug 2018 wwwepgonlineorgusnewsfda-approves-cequa-to-treat-dry-eye-syndrome---sun-pharma---sun--ophthalmics-html

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Cyclosporine 005 and 01 (CyclASol Novaliq)

bull Semifluorinated alkanes formulation better dissolves Cyclosporine Abull Greater penetration than FDA-approved 005 Cyclosporine A

(Restasis)bull Evidence of decreased corneal and conjunctival staining after 14

days2

bull It remains unknown whether greater concentration leads to better results phase 3 studies are underway3

2Novaliq CyclASolreg ndash Cyclosporine in SFA for Ophthalmological Application to Treat Dry Eye Syndrome 20153 Lallemand F Shmitt M Bourges JL et al Cyclosporine A delivery to the eye a comprehensive review of academic and industrial efforts Eur J Pharm Biopharm 201711714-28

2018

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Cyclosporin with chondroiton sulphate

Klarity- C

Imprimis- compounded

chondroitin sulfate

2018

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SkQ1 bull Main effects synthesized small molecule targeted to reduce oxidative stress in cellmitochondria

o Regenerates itself o SkQ1 ophthalmic solution is indicated for pathologies of the eye associated with

oxidative stress such as dry eye 1

o Approved in Russia (2011) and marketed as Visomitinbull Clinical evidence suggest statistically significant 2

o Decrease in corneal stainingo Improvements in lid margin rednesso Improvements in symptoms measuredo through Ora CalibraTM scales

1Wakamatsu TH Dogru M Tsubota K Tearful relations oxidative stress inflammation and eye diseases Arq Bras Oftalmol 200871(6 Suppl)72ndash92Petrov Anton et al SkQ1 ophthalmic solution for dry eye treatment results of a phase 2 safety and efficacy clinical study in the environment and during challenge in the controlled adverse environment model Advances in therapy 331 (2016) 96-115

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Steroids- new formulation bullKPI-121- Kala Pharmaceuticals

bullMucous ndash penetrating particle ( MPP) ndashbullnano particles

bullLoteprednol -025

bull Better penetration low dose steroid

bullEpisodic flare ups of DED

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ADX-102 (Reproxalap Aldeyra Therapeutics)bull Small molecule topical agentbull Traps aldehydes that usually activate inflammatory factorsbull Positive clinical evidence of improvement in signs and

symptoms of dry eye1

Thymosin beta 4 (Tβ4 ) bull 43-amino acid G-actin binding proteinbull Downregulates transcription of inflammatory mediators and promotes corneal

epithelial cell migrationbull Phase 3 clinical trial with Tβ4 (RGN-259 RegeneRx) showed improvement in signs

and symptoms of dry eye through corneal staining tear production and expression of inflammatory factors2

1Aldehyde trap drug rapidly improves signs symptoms of dry eye disease American Academy of Ophthalmology (2017) httpswwwaaoorgheadlinealdehyde-trap-drug-rapidly-improves-signs-symptoms2Kim Chae Eun et al RGN-259 (thymosin β4) improves clinically important dry eye efficacies in comparison with prescription drugs in a dry eye model Scientific reports 81 (2018) 10500

Aldeyracom

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Tear Enhancements

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bull Currently approved in Japan and South Korea1

bull Main Effect Increase tear fluid and mucin secretion on the ocular surface through interaction with P2Y2 receptors in the conjunctiva

bull Evidence from clinical trials suggest diquafosol improves corneal staining more effectively than a comparable sodium hyaluronate solution2

Diquafosol Tetrasodium(3 Ophthalmic Solution)

1Koh Shizuka Clinical utility of 3 diquafosol ophthalmic solution in the treatment of dry eyes Clinical Ophthalmology (Auckland NZ) 9 (2015) 8652Takamura Etsuko et al A randomised double-masked comparison study of diquafosol versus sodium hyaluronate ophthalmic solutions in dry eye patients British Journal of Ophthalmology 9610 (2012) 1310-1315

Pubmedcom

Santencom

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Rebapimide

(2 Ophthalmic Solution)

bull Currently approved in Japanbull Main Effect stimulates mucin secretagogue activity in

cornea and conjunctivabull Clinical evidence suggests

o Statistically significant Improvement in corneal and conjunctival staining as well as in quality of life as well as in tear break-up time12

o Potential role in suppressing the expression of inflammatory proteins (Polyl)3

1 Kinoshita Shigeru et al Rebamipide (OPC-12759) in the treatment of dry eye a randomized double-masked multicenter placebo-controlled phase II study Ophthalmology11912 (2012) 2471-24782 Kashima Tomoyuki et al Rebamipide ophthalmic suspension for the treatment of dry eye syndrome a critical appraisal Clinical ophthalmology (Auckland NZ) 8 (2014) 10033Ueta Mayumi et al Rebamipide suppresses PolyI C-stimulated cytokine production in human conjunctival epithelial cells Journal of Ocular Pharmacology and Therapeutics 297 (2013) 688-693

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TrueTearreg Allerganbull FDA Clearancebull Main effect intranasal applicator sends

electrical currents to nerves that stimulate tear production

bull Evidence of improved Schirmer scores decreased symptoms and corneal and conjunctival staining at 6 mo Ocular comfort lasted for 3 hours following neurostimulationo Secondary effect intranasal application

promotes goblet cell mucin secretion which stabilizes the tear film1

Truetearcom

1Gumus K Schuetzle KL Pflugfelder SC Randomized controlled crossover trial comparing the impact of sham or intranasal tear neurostimulation on 654 GD Novack et al The Ocular Surface xxx (2017) 635e655 conjunctival goblet cell degranulation Am J Ophthalmol 2017177159e68

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Pharmaceutical to stimulate nerves

bullNasal Spray OC-01

bullOyster Point Pharma

bullStimulate natural tears

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Amniotic cytokine extract(Ocular Science)bullACE is a novel drop marketed as Genesis bullContains various cytokines growth factor

and anti-inflammatory moleculesbull Effective in a small pilot study

Amniotic Cytokine Extract Promising in Patients with Dry Ey Disease MDLinx

httpswwwmdlinxcomophthalmologyarticle1280 1113088 Accessed Jan 27 2018

Amniotic Cytokine Extract Promising in Patients with Dry Ey Disease MDLinx

httpswwwmdlinxcomophthalmologyarticle1280 1113088 Accessed Jan 27 2

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Recombinant human nerve growth factor (OxervateTM eye drops Dompeacute)

bull FDA Approval Aug 2018o First approved drug for Neurotropic keratitis (NK) ndashdegenerative disease with loss of corneal sensation o Topical eye drop o Clinical evidence of complete corneal healing in 70 of patients treated with Oxervate after 8 weeks1

1Bonini S et al Phase II Randomized Double-Masked Vehicle-Controlled Trial of Recombinant Human Nerve Growth Factor for Neurotrophic Keratitis Ophthalmology 125 1332ndash1343 (2018)

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Perfluorohexyloctane (NovaTears Novaliq)

bull Main effect prevent evaporative DED by increasing tear film and lipid layer thickness

bull Approved in Europe Australia and New Zealandbull Clinical evidence of increased tear production and tear film

stability as well as significant decrease in OSDI scores and in corneal staining1

1Steven P et al Semifluorinated Alkane Eye Drops for Treatment of Dry Eye Disease ndash A Prospective Multicenter Noninterventional Study J Ocul Pharmacol Ther 2015 Oct 1 31(8) 498-503

Corneal Epithelium Healing

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CrossThiolated Carboxymethyl Hyaluronic Acid Liquid-Gel

(Ocular Bandage Gel EyeGate Pharma)

bull Main effects accelerate corneal healing and reduce corneal stainingo Indicated for defects due to photorefcrative keratectomy (PRK)o Indicated for Punctate epitheliopathies (PE) associated with

dry eyebull Treatment in development July 2018 approval to conduct two

pilot studies using OBG for PE and PRKbull A first-in-human pilot study (n=39) showed accelerated corneal

reepithelialization through slit lamp examination at day 1 after PRK Further studies needed1

1Durrie Daniel S et al Ability of a new crosslinked polymer ocular bandage gel to accelerate reepithelialization after photorefractive keratectomy Journal of Cataract amp Refractive Surgery 443 (2018) 369-375

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Biologic MoleculesDry Eye Assessment

bull Proteoglycan-4 (Lubricin)oRecently discovered on the ocular surface in the meibomian glands2

oFunctions to prevent friction at the cornea-lid interface and has anti-inflammatory propertiesoCommercial lubricin-based lubricants remain scarceoEvidence from clinical studies with recombinant human lubricin suggest

significant improvement in signs and symptoms of DED through TBUT corneal staining and eyelid and conjunctival redness3

1De Paiva CS Chotikavanich S Pangelinan SB Pitcher 3rd JD Fang B Zheng X et al IL-17 disrupts corneal barrier following desiccating stress Mucosal Immunol 20092(3)243ndash2532Iqbal SM Leonard C Regmi SC De Rantere D Tailor P Ren G et al LubricinProteoglycan 4 binds to and regulates the activity of Toll-Like Receptors In Vitro Sci Rep20166189103Lambiase A Sullivan BD Schmidt TA Sullivan DA Jay GD Truitt ER et al A Two-Week Randomized Double-masked Study to Evaluate Safety and Efficacy of Lubricin

(150 mugmL) Eye Drops Versus Sodium Hyaluronate (HA) 018 Eye Drops (Vismed(R)) in Patients with Moderate Dry Eye Disease Ocul Surf 20171577ndash87

2018

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Why Ocular Biomarkers

Surrogate Endpoints- None accepted by the FDA or Europe to date Validation needed- clear clinical relevance

Enrichment of Study Population Still regulatory hurdles

Support mechanism of action of treatment Topical ciclosporin in Europe for Dry eyes (Europe2015 Ikervis)1

SEGMENT THE DRY EYE POPULATION- TREAT MORE SPECIFICALLY-PERSONALIZE TREATMENT

1 Ikervis SmPC June 2015 available at httpswwwmedicinesorgukemcmedicine30584

2018

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iLuxreg Tear Film Innovationsbull Main effect unblocks Meibomian glandsbull Heat amp pressure therapybull 8-12 min treatmentbull Handheld Devicebull Glands can be viewed via magnifier

bull No clinically significant differences between iLux and LipiFlow with respect to indication for use and device performance1

1ldquo510(K) SUMMARY ndash K172645rdquo US Food amp Drug Administration Dec 2017 wwwaccessdatafdagovcdrh_docspdf17K172645pdf

2018

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BlephExreg Rysurgbull FDA clearance bull Main effect lid margin debridement bull 6-8 minute treatmentbull In-officebull Lasts three to six months before requiring a

retreatmentbull Evidence of improvement for contact lens

wearers through significant reduction in bacterial load on patientsrsquo eyelids1

1Siddireddy JS Tan-Showyin J Vijay AK Willcox M A Comfortable Eye Needs Fats Presented at the University of New South Wales Sydney Australia 2015

Rysurgcom

2018

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Blephasteamreg Laboratoires Theacuteabull Main effect warming goggles that promote fluidization Meibomian glands secretions through heat and pressure bull ESPOIR Study evidence of significant improvement in symptoms using the visual analogous scale (VAS)1

bull Expensive devicebull Need further studies with larger samples sizes

to determine efficacy2

1 Doan S Chiambaretta F Gabison EE Cochereau I Baudoin C Efficacy of heating wet chamber warming goggles (Blephasteamreg) in adult posterior blepharitis Invest Opthalmol Vis Sci 201152 E-Abstract 38332Benitez Del Castillo JM Kaercher T Mansour K Wylegala E Dua H Evaluation of the efficacy safety and acceptability of an eyelid warming device for the treatment of meibomian gland dysfunction Clin Ophthalmol 201482019ndash2027

2018

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NuLidstrade NuSight

bull Main effect lid scrub that stimulates Meibomian glands by removing biofilm and scurf that block the opening of the glands

bull Doctor-prescribed In-home treatmentbull 60 second daily treatmentbull A multi-center clinical study showed

evidence of 50 decrease in dry eye symptoms 65 improvement in TBUT and 81 improvement in Meibomian Gland liquid secretions1

1Schanzlin Olkowski Coble Gross NuLids II Study April 2018

2018

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TearCare System Sight Sciences

bull First wearable therapeutic eyelid therapy devicebull In-office treatmentbull 12 minute thermal eyelid treatment followed by expression forceps to

manually evacuate residual obstructionsbull Evidence from pilot study suggested improved TBUT corneal and

conjunctival staining scored and dry eye symptoms based on OSDI SPEED and SANDE1

bull Further clinical evidence underway

Badawi David A novel system TearCarereg for the treatment of the signs and symptoms of dry eye disease Clinical Ophthalmology (Auckland NZ) 12 (2018) 683

2018

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Anti-Inflammatory Pharmaceuticals

Cyclosporine

Main effectbull Anti-inflammatory therapy

bull Inhibits T-cell maturation

bull Decreases pro-inflammatory cytokines

bull Upregulates anti-inflammatory cytokines20

18 copy

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Cyclosporine A cationic emulsion 01 (Ikervisreg Santen)

bull Approved in Europe in 2015bull Main effect prolonged precorneal residence time and improved

bioavailabilityo Indicated for patients with severe DED that has not improved

using tear substitutesbull Clinical evidence of reduced HLA-DR expression at 6 mo measured

through impression cytology overall greater benefits for patients with Sjoumlgrenrsquos Syndrome1

1Leonardi A Messmer EM Labetoulle M et al Efficacy and safety of 01 ciclosporin A cationic emulsion in dry eye disease a pooled analysis of two double-masked randomised vehicle-controlled phase III clinical studies Br J Ophthalmol 2018

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Cyclosporine 009 (OTX-101 CequaTM Sun Pharma)

bull FDA Approval Aug 2018

bull Highest FDA-approved concentration of cyclosporine A1

bull Main effect Increase tear production

bull Calcineurin inhibitor

bull Nanomicellar formulation eases entry into corneal and conjunctival cells

bull Two multicenter studies report a statistically significant increase (ge 10 mm) in Schirmer wetting at 3 mo in patients receiving CequaTM vs vehicle1

Cyclosporine - New Preparations

Biospacecom

1epgonlineorg ldquoFDA Approves CEQUA to Treat Dry Eye Syndrome- Sun Pharma + Sun Ophthalmicsrdquo Epgonlineorg Aug 2018 wwwepgonlineorgusnewsfda-approves-cequa-to-treat-dry-eye-syndrome---sun-pharma---sun--ophthalmics-html

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Cyclosporine 005 and 01 (CyclASol Novaliq)

bull Semifluorinated alkanes formulation better dissolves Cyclosporine Abull Greater penetration than FDA-approved 005 Cyclosporine A

(Restasis)bull Evidence of decreased corneal and conjunctival staining after 14

days2

bull It remains unknown whether greater concentration leads to better results phase 3 studies are underway3

2Novaliq CyclASolreg ndash Cyclosporine in SFA for Ophthalmological Application to Treat Dry Eye Syndrome 20153 Lallemand F Shmitt M Bourges JL et al Cyclosporine A delivery to the eye a comprehensive review of academic and industrial efforts Eur J Pharm Biopharm 201711714-28

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Cyclosporin with chondroiton sulphate

Klarity- C

Imprimis- compounded

chondroitin sulfate

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SkQ1 bull Main effects synthesized small molecule targeted to reduce oxidative stress in cellmitochondria

o Regenerates itself o SkQ1 ophthalmic solution is indicated for pathologies of the eye associated with

oxidative stress such as dry eye 1

o Approved in Russia (2011) and marketed as Visomitinbull Clinical evidence suggest statistically significant 2

o Decrease in corneal stainingo Improvements in lid margin rednesso Improvements in symptoms measuredo through Ora CalibraTM scales

1Wakamatsu TH Dogru M Tsubota K Tearful relations oxidative stress inflammation and eye diseases Arq Bras Oftalmol 200871(6 Suppl)72ndash92Petrov Anton et al SkQ1 ophthalmic solution for dry eye treatment results of a phase 2 safety and efficacy clinical study in the environment and during challenge in the controlled adverse environment model Advances in therapy 331 (2016) 96-115

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Steroids- new formulation bullKPI-121- Kala Pharmaceuticals

bullMucous ndash penetrating particle ( MPP) ndashbullnano particles

bullLoteprednol -025

bull Better penetration low dose steroid

bullEpisodic flare ups of DED

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ADX-102 (Reproxalap Aldeyra Therapeutics)bull Small molecule topical agentbull Traps aldehydes that usually activate inflammatory factorsbull Positive clinical evidence of improvement in signs and

symptoms of dry eye1

Thymosin beta 4 (Tβ4 ) bull 43-amino acid G-actin binding proteinbull Downregulates transcription of inflammatory mediators and promotes corneal

epithelial cell migrationbull Phase 3 clinical trial with Tβ4 (RGN-259 RegeneRx) showed improvement in signs

and symptoms of dry eye through corneal staining tear production and expression of inflammatory factors2

1Aldehyde trap drug rapidly improves signs symptoms of dry eye disease American Academy of Ophthalmology (2017) httpswwwaaoorgheadlinealdehyde-trap-drug-rapidly-improves-signs-symptoms2Kim Chae Eun et al RGN-259 (thymosin β4) improves clinically important dry eye efficacies in comparison with prescription drugs in a dry eye model Scientific reports 81 (2018) 10500

Aldeyracom

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Tear Enhancements

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bull Currently approved in Japan and South Korea1

bull Main Effect Increase tear fluid and mucin secretion on the ocular surface through interaction with P2Y2 receptors in the conjunctiva

bull Evidence from clinical trials suggest diquafosol improves corneal staining more effectively than a comparable sodium hyaluronate solution2

Diquafosol Tetrasodium(3 Ophthalmic Solution)

1Koh Shizuka Clinical utility of 3 diquafosol ophthalmic solution in the treatment of dry eyes Clinical Ophthalmology (Auckland NZ) 9 (2015) 8652Takamura Etsuko et al A randomised double-masked comparison study of diquafosol versus sodium hyaluronate ophthalmic solutions in dry eye patients British Journal of Ophthalmology 9610 (2012) 1310-1315

Pubmedcom

Santencom

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Rebapimide

(2 Ophthalmic Solution)

bull Currently approved in Japanbull Main Effect stimulates mucin secretagogue activity in

cornea and conjunctivabull Clinical evidence suggests

o Statistically significant Improvement in corneal and conjunctival staining as well as in quality of life as well as in tear break-up time12

o Potential role in suppressing the expression of inflammatory proteins (Polyl)3

1 Kinoshita Shigeru et al Rebamipide (OPC-12759) in the treatment of dry eye a randomized double-masked multicenter placebo-controlled phase II study Ophthalmology11912 (2012) 2471-24782 Kashima Tomoyuki et al Rebamipide ophthalmic suspension for the treatment of dry eye syndrome a critical appraisal Clinical ophthalmology (Auckland NZ) 8 (2014) 10033Ueta Mayumi et al Rebamipide suppresses PolyI C-stimulated cytokine production in human conjunctival epithelial cells Journal of Ocular Pharmacology and Therapeutics 297 (2013) 688-693

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TrueTearreg Allerganbull FDA Clearancebull Main effect intranasal applicator sends

electrical currents to nerves that stimulate tear production

bull Evidence of improved Schirmer scores decreased symptoms and corneal and conjunctival staining at 6 mo Ocular comfort lasted for 3 hours following neurostimulationo Secondary effect intranasal application

promotes goblet cell mucin secretion which stabilizes the tear film1

Truetearcom

1Gumus K Schuetzle KL Pflugfelder SC Randomized controlled crossover trial comparing the impact of sham or intranasal tear neurostimulation on 654 GD Novack et al The Ocular Surface xxx (2017) 635e655 conjunctival goblet cell degranulation Am J Ophthalmol 2017177159e68

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Pharmaceutical to stimulate nerves

bullNasal Spray OC-01

bullOyster Point Pharma

bullStimulate natural tears

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Amniotic cytokine extract(Ocular Science)bullACE is a novel drop marketed as Genesis bullContains various cytokines growth factor

and anti-inflammatory moleculesbull Effective in a small pilot study

Amniotic Cytokine Extract Promising in Patients with Dry Ey Disease MDLinx

httpswwwmdlinxcomophthalmologyarticle1280 1113088 Accessed Jan 27 2018

Amniotic Cytokine Extract Promising in Patients with Dry Ey Disease MDLinx

httpswwwmdlinxcomophthalmologyarticle1280 1113088 Accessed Jan 27 2

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Recombinant human nerve growth factor (OxervateTM eye drops Dompeacute)

bull FDA Approval Aug 2018o First approved drug for Neurotropic keratitis (NK) ndashdegenerative disease with loss of corneal sensation o Topical eye drop o Clinical evidence of complete corneal healing in 70 of patients treated with Oxervate after 8 weeks1

1Bonini S et al Phase II Randomized Double-Masked Vehicle-Controlled Trial of Recombinant Human Nerve Growth Factor for Neurotrophic Keratitis Ophthalmology 125 1332ndash1343 (2018)

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Perfluorohexyloctane (NovaTears Novaliq)

bull Main effect prevent evaporative DED by increasing tear film and lipid layer thickness

bull Approved in Europe Australia and New Zealandbull Clinical evidence of increased tear production and tear film

stability as well as significant decrease in OSDI scores and in corneal staining1

1Steven P et al Semifluorinated Alkane Eye Drops for Treatment of Dry Eye Disease ndash A Prospective Multicenter Noninterventional Study J Ocul Pharmacol Ther 2015 Oct 1 31(8) 498-503

Corneal Epithelium Healing

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CrossThiolated Carboxymethyl Hyaluronic Acid Liquid-Gel

(Ocular Bandage Gel EyeGate Pharma)

bull Main effects accelerate corneal healing and reduce corneal stainingo Indicated for defects due to photorefcrative keratectomy (PRK)o Indicated for Punctate epitheliopathies (PE) associated with

dry eyebull Treatment in development July 2018 approval to conduct two

pilot studies using OBG for PE and PRKbull A first-in-human pilot study (n=39) showed accelerated corneal

reepithelialization through slit lamp examination at day 1 after PRK Further studies needed1

1Durrie Daniel S et al Ability of a new crosslinked polymer ocular bandage gel to accelerate reepithelialization after photorefractive keratectomy Journal of Cataract amp Refractive Surgery 443 (2018) 369-375

2018

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Biologic MoleculesDry Eye Assessment

bull Proteoglycan-4 (Lubricin)oRecently discovered on the ocular surface in the meibomian glands2

oFunctions to prevent friction at the cornea-lid interface and has anti-inflammatory propertiesoCommercial lubricin-based lubricants remain scarceoEvidence from clinical studies with recombinant human lubricin suggest

significant improvement in signs and symptoms of DED through TBUT corneal staining and eyelid and conjunctival redness3

1De Paiva CS Chotikavanich S Pangelinan SB Pitcher 3rd JD Fang B Zheng X et al IL-17 disrupts corneal barrier following desiccating stress Mucosal Immunol 20092(3)243ndash2532Iqbal SM Leonard C Regmi SC De Rantere D Tailor P Ren G et al LubricinProteoglycan 4 binds to and regulates the activity of Toll-Like Receptors In Vitro Sci Rep20166189103Lambiase A Sullivan BD Schmidt TA Sullivan DA Jay GD Truitt ER et al A Two-Week Randomized Double-masked Study to Evaluate Safety and Efficacy of Lubricin

(150 mugmL) Eye Drops Versus Sodium Hyaluronate (HA) 018 Eye Drops (Vismed(R)) in Patients with Moderate Dry Eye Disease Ocul Surf 20171577ndash87

2018

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Why Ocular Biomarkers

Surrogate Endpoints- None accepted by the FDA or Europe to date Validation needed- clear clinical relevance

Enrichment of Study Population Still regulatory hurdles

Support mechanism of action of treatment Topical ciclosporin in Europe for Dry eyes (Europe2015 Ikervis)1

SEGMENT THE DRY EYE POPULATION- TREAT MORE SPECIFICALLY-PERSONALIZE TREATMENT

1 Ikervis SmPC June 2015 available at httpswwwmedicinesorgukemcmedicine30584

2018

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BlephExreg Rysurgbull FDA clearance bull Main effect lid margin debridement bull 6-8 minute treatmentbull In-officebull Lasts three to six months before requiring a

retreatmentbull Evidence of improvement for contact lens

wearers through significant reduction in bacterial load on patientsrsquo eyelids1

1Siddireddy JS Tan-Showyin J Vijay AK Willcox M A Comfortable Eye Needs Fats Presented at the University of New South Wales Sydney Australia 2015

Rysurgcom

2018

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Blephasteamreg Laboratoires Theacuteabull Main effect warming goggles that promote fluidization Meibomian glands secretions through heat and pressure bull ESPOIR Study evidence of significant improvement in symptoms using the visual analogous scale (VAS)1

bull Expensive devicebull Need further studies with larger samples sizes

to determine efficacy2

1 Doan S Chiambaretta F Gabison EE Cochereau I Baudoin C Efficacy of heating wet chamber warming goggles (Blephasteamreg) in adult posterior blepharitis Invest Opthalmol Vis Sci 201152 E-Abstract 38332Benitez Del Castillo JM Kaercher T Mansour K Wylegala E Dua H Evaluation of the efficacy safety and acceptability of an eyelid warming device for the treatment of meibomian gland dysfunction Clin Ophthalmol 201482019ndash2027

2018

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NuLidstrade NuSight

bull Main effect lid scrub that stimulates Meibomian glands by removing biofilm and scurf that block the opening of the glands

bull Doctor-prescribed In-home treatmentbull 60 second daily treatmentbull A multi-center clinical study showed

evidence of 50 decrease in dry eye symptoms 65 improvement in TBUT and 81 improvement in Meibomian Gland liquid secretions1

1Schanzlin Olkowski Coble Gross NuLids II Study April 2018

2018

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TearCare System Sight Sciences

bull First wearable therapeutic eyelid therapy devicebull In-office treatmentbull 12 minute thermal eyelid treatment followed by expression forceps to

manually evacuate residual obstructionsbull Evidence from pilot study suggested improved TBUT corneal and

conjunctival staining scored and dry eye symptoms based on OSDI SPEED and SANDE1

bull Further clinical evidence underway

Badawi David A novel system TearCarereg for the treatment of the signs and symptoms of dry eye disease Clinical Ophthalmology (Auckland NZ) 12 (2018) 683

2018

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Anti-Inflammatory Pharmaceuticals

Cyclosporine

Main effectbull Anti-inflammatory therapy

bull Inhibits T-cell maturation

bull Decreases pro-inflammatory cytokines

bull Upregulates anti-inflammatory cytokines20

18 copy

48th

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ean C

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Cyclosporine A cationic emulsion 01 (Ikervisreg Santen)

bull Approved in Europe in 2015bull Main effect prolonged precorneal residence time and improved

bioavailabilityo Indicated for patients with severe DED that has not improved

using tear substitutesbull Clinical evidence of reduced HLA-DR expression at 6 mo measured

through impression cytology overall greater benefits for patients with Sjoumlgrenrsquos Syndrome1

1Leonardi A Messmer EM Labetoulle M et al Efficacy and safety of 01 ciclosporin A cationic emulsion in dry eye disease a pooled analysis of two double-masked randomised vehicle-controlled phase III clinical studies Br J Ophthalmol 2018

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Cyclosporine 009 (OTX-101 CequaTM Sun Pharma)

bull FDA Approval Aug 2018

bull Highest FDA-approved concentration of cyclosporine A1

bull Main effect Increase tear production

bull Calcineurin inhibitor

bull Nanomicellar formulation eases entry into corneal and conjunctival cells

bull Two multicenter studies report a statistically significant increase (ge 10 mm) in Schirmer wetting at 3 mo in patients receiving CequaTM vs vehicle1

Cyclosporine - New Preparations

Biospacecom

1epgonlineorg ldquoFDA Approves CEQUA to Treat Dry Eye Syndrome- Sun Pharma + Sun Ophthalmicsrdquo Epgonlineorg Aug 2018 wwwepgonlineorgusnewsfda-approves-cequa-to-treat-dry-eye-syndrome---sun-pharma---sun--ophthalmics-html

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Cyclosporine 005 and 01 (CyclASol Novaliq)

bull Semifluorinated alkanes formulation better dissolves Cyclosporine Abull Greater penetration than FDA-approved 005 Cyclosporine A

(Restasis)bull Evidence of decreased corneal and conjunctival staining after 14

days2

bull It remains unknown whether greater concentration leads to better results phase 3 studies are underway3

2Novaliq CyclASolreg ndash Cyclosporine in SFA for Ophthalmological Application to Treat Dry Eye Syndrome 20153 Lallemand F Shmitt M Bourges JL et al Cyclosporine A delivery to the eye a comprehensive review of academic and industrial efforts Eur J Pharm Biopharm 201711714-28

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Cyclosporin with chondroiton sulphate

Klarity- C

Imprimis- compounded

chondroitin sulfate

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SkQ1 bull Main effects synthesized small molecule targeted to reduce oxidative stress in cellmitochondria

o Regenerates itself o SkQ1 ophthalmic solution is indicated for pathologies of the eye associated with

oxidative stress such as dry eye 1

o Approved in Russia (2011) and marketed as Visomitinbull Clinical evidence suggest statistically significant 2

o Decrease in corneal stainingo Improvements in lid margin rednesso Improvements in symptoms measuredo through Ora CalibraTM scales

1Wakamatsu TH Dogru M Tsubota K Tearful relations oxidative stress inflammation and eye diseases Arq Bras Oftalmol 200871(6 Suppl)72ndash92Petrov Anton et al SkQ1 ophthalmic solution for dry eye treatment results of a phase 2 safety and efficacy clinical study in the environment and during challenge in the controlled adverse environment model Advances in therapy 331 (2016) 96-115

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Steroids- new formulation bullKPI-121- Kala Pharmaceuticals

bullMucous ndash penetrating particle ( MPP) ndashbullnano particles

bullLoteprednol -025

bull Better penetration low dose steroid

bullEpisodic flare ups of DED

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ADX-102 (Reproxalap Aldeyra Therapeutics)bull Small molecule topical agentbull Traps aldehydes that usually activate inflammatory factorsbull Positive clinical evidence of improvement in signs and

symptoms of dry eye1

Thymosin beta 4 (Tβ4 ) bull 43-amino acid G-actin binding proteinbull Downregulates transcription of inflammatory mediators and promotes corneal

epithelial cell migrationbull Phase 3 clinical trial with Tβ4 (RGN-259 RegeneRx) showed improvement in signs

and symptoms of dry eye through corneal staining tear production and expression of inflammatory factors2

1Aldehyde trap drug rapidly improves signs symptoms of dry eye disease American Academy of Ophthalmology (2017) httpswwwaaoorgheadlinealdehyde-trap-drug-rapidly-improves-signs-symptoms2Kim Chae Eun et al RGN-259 (thymosin β4) improves clinically important dry eye efficacies in comparison with prescription drugs in a dry eye model Scientific reports 81 (2018) 10500

Aldeyracom

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Tear Enhancements

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bull Currently approved in Japan and South Korea1

bull Main Effect Increase tear fluid and mucin secretion on the ocular surface through interaction with P2Y2 receptors in the conjunctiva

bull Evidence from clinical trials suggest diquafosol improves corneal staining more effectively than a comparable sodium hyaluronate solution2

Diquafosol Tetrasodium(3 Ophthalmic Solution)

1Koh Shizuka Clinical utility of 3 diquafosol ophthalmic solution in the treatment of dry eyes Clinical Ophthalmology (Auckland NZ) 9 (2015) 8652Takamura Etsuko et al A randomised double-masked comparison study of diquafosol versus sodium hyaluronate ophthalmic solutions in dry eye patients British Journal of Ophthalmology 9610 (2012) 1310-1315

Pubmedcom

Santencom

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Rebapimide

(2 Ophthalmic Solution)

bull Currently approved in Japanbull Main Effect stimulates mucin secretagogue activity in

cornea and conjunctivabull Clinical evidence suggests

o Statistically significant Improvement in corneal and conjunctival staining as well as in quality of life as well as in tear break-up time12

o Potential role in suppressing the expression of inflammatory proteins (Polyl)3

1 Kinoshita Shigeru et al Rebamipide (OPC-12759) in the treatment of dry eye a randomized double-masked multicenter placebo-controlled phase II study Ophthalmology11912 (2012) 2471-24782 Kashima Tomoyuki et al Rebamipide ophthalmic suspension for the treatment of dry eye syndrome a critical appraisal Clinical ophthalmology (Auckland NZ) 8 (2014) 10033Ueta Mayumi et al Rebamipide suppresses PolyI C-stimulated cytokine production in human conjunctival epithelial cells Journal of Ocular Pharmacology and Therapeutics 297 (2013) 688-693

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TrueTearreg Allerganbull FDA Clearancebull Main effect intranasal applicator sends

electrical currents to nerves that stimulate tear production

bull Evidence of improved Schirmer scores decreased symptoms and corneal and conjunctival staining at 6 mo Ocular comfort lasted for 3 hours following neurostimulationo Secondary effect intranasal application

promotes goblet cell mucin secretion which stabilizes the tear film1

Truetearcom

1Gumus K Schuetzle KL Pflugfelder SC Randomized controlled crossover trial comparing the impact of sham or intranasal tear neurostimulation on 654 GD Novack et al The Ocular Surface xxx (2017) 635e655 conjunctival goblet cell degranulation Am J Ophthalmol 2017177159e68

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Pharmaceutical to stimulate nerves

bullNasal Spray OC-01

bullOyster Point Pharma

bullStimulate natural tears

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Amniotic cytokine extract(Ocular Science)bullACE is a novel drop marketed as Genesis bullContains various cytokines growth factor

and anti-inflammatory moleculesbull Effective in a small pilot study

Amniotic Cytokine Extract Promising in Patients with Dry Ey Disease MDLinx

httpswwwmdlinxcomophthalmologyarticle1280 1113088 Accessed Jan 27 2018

Amniotic Cytokine Extract Promising in Patients with Dry Ey Disease MDLinx

httpswwwmdlinxcomophthalmologyarticle1280 1113088 Accessed Jan 27 2

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Recombinant human nerve growth factor (OxervateTM eye drops Dompeacute)

bull FDA Approval Aug 2018o First approved drug for Neurotropic keratitis (NK) ndashdegenerative disease with loss of corneal sensation o Topical eye drop o Clinical evidence of complete corneal healing in 70 of patients treated with Oxervate after 8 weeks1

1Bonini S et al Phase II Randomized Double-Masked Vehicle-Controlled Trial of Recombinant Human Nerve Growth Factor for Neurotrophic Keratitis Ophthalmology 125 1332ndash1343 (2018)

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Perfluorohexyloctane (NovaTears Novaliq)

bull Main effect prevent evaporative DED by increasing tear film and lipid layer thickness

bull Approved in Europe Australia and New Zealandbull Clinical evidence of increased tear production and tear film

stability as well as significant decrease in OSDI scores and in corneal staining1

1Steven P et al Semifluorinated Alkane Eye Drops for Treatment of Dry Eye Disease ndash A Prospective Multicenter Noninterventional Study J Ocul Pharmacol Ther 2015 Oct 1 31(8) 498-503

Corneal Epithelium Healing

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CrossThiolated Carboxymethyl Hyaluronic Acid Liquid-Gel

(Ocular Bandage Gel EyeGate Pharma)

bull Main effects accelerate corneal healing and reduce corneal stainingo Indicated for defects due to photorefcrative keratectomy (PRK)o Indicated for Punctate epitheliopathies (PE) associated with

dry eyebull Treatment in development July 2018 approval to conduct two

pilot studies using OBG for PE and PRKbull A first-in-human pilot study (n=39) showed accelerated corneal

reepithelialization through slit lamp examination at day 1 after PRK Further studies needed1

1Durrie Daniel S et al Ability of a new crosslinked polymer ocular bandage gel to accelerate reepithelialization after photorefractive keratectomy Journal of Cataract amp Refractive Surgery 443 (2018) 369-375

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Biologic MoleculesDry Eye Assessment

bull Proteoglycan-4 (Lubricin)oRecently discovered on the ocular surface in the meibomian glands2

oFunctions to prevent friction at the cornea-lid interface and has anti-inflammatory propertiesoCommercial lubricin-based lubricants remain scarceoEvidence from clinical studies with recombinant human lubricin suggest

significant improvement in signs and symptoms of DED through TBUT corneal staining and eyelid and conjunctival redness3

1De Paiva CS Chotikavanich S Pangelinan SB Pitcher 3rd JD Fang B Zheng X et al IL-17 disrupts corneal barrier following desiccating stress Mucosal Immunol 20092(3)243ndash2532Iqbal SM Leonard C Regmi SC De Rantere D Tailor P Ren G et al LubricinProteoglycan 4 binds to and regulates the activity of Toll-Like Receptors In Vitro Sci Rep20166189103Lambiase A Sullivan BD Schmidt TA Sullivan DA Jay GD Truitt ER et al A Two-Week Randomized Double-masked Study to Evaluate Safety and Efficacy of Lubricin

(150 mugmL) Eye Drops Versus Sodium Hyaluronate (HA) 018 Eye Drops (Vismed(R)) in Patients with Moderate Dry Eye Disease Ocul Surf 20171577ndash87

2018

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Why Ocular Biomarkers

Surrogate Endpoints- None accepted by the FDA or Europe to date Validation needed- clear clinical relevance

Enrichment of Study Population Still regulatory hurdles

Support mechanism of action of treatment Topical ciclosporin in Europe for Dry eyes (Europe2015 Ikervis)1

SEGMENT THE DRY EYE POPULATION- TREAT MORE SPECIFICALLY-PERSONALIZE TREATMENT

1 Ikervis SmPC June 2015 available at httpswwwmedicinesorgukemcmedicine30584

2018

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Blephasteamreg Laboratoires Theacuteabull Main effect warming goggles that promote fluidization Meibomian glands secretions through heat and pressure bull ESPOIR Study evidence of significant improvement in symptoms using the visual analogous scale (VAS)1

bull Expensive devicebull Need further studies with larger samples sizes

to determine efficacy2

1 Doan S Chiambaretta F Gabison EE Cochereau I Baudoin C Efficacy of heating wet chamber warming goggles (Blephasteamreg) in adult posterior blepharitis Invest Opthalmol Vis Sci 201152 E-Abstract 38332Benitez Del Castillo JM Kaercher T Mansour K Wylegala E Dua H Evaluation of the efficacy safety and acceptability of an eyelid warming device for the treatment of meibomian gland dysfunction Clin Ophthalmol 201482019ndash2027

2018

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NuLidstrade NuSight

bull Main effect lid scrub that stimulates Meibomian glands by removing biofilm and scurf that block the opening of the glands

bull Doctor-prescribed In-home treatmentbull 60 second daily treatmentbull A multi-center clinical study showed

evidence of 50 decrease in dry eye symptoms 65 improvement in TBUT and 81 improvement in Meibomian Gland liquid secretions1

1Schanzlin Olkowski Coble Gross NuLids II Study April 2018

2018

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TearCare System Sight Sciences

bull First wearable therapeutic eyelid therapy devicebull In-office treatmentbull 12 minute thermal eyelid treatment followed by expression forceps to

manually evacuate residual obstructionsbull Evidence from pilot study suggested improved TBUT corneal and

conjunctival staining scored and dry eye symptoms based on OSDI SPEED and SANDE1

bull Further clinical evidence underway

Badawi David A novel system TearCarereg for the treatment of the signs and symptoms of dry eye disease Clinical Ophthalmology (Auckland NZ) 12 (2018) 683

2018

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Anti-Inflammatory Pharmaceuticals

Cyclosporine

Main effectbull Anti-inflammatory therapy

bull Inhibits T-cell maturation

bull Decreases pro-inflammatory cytokines

bull Upregulates anti-inflammatory cytokines20

18 copy

48th

Europ

ean C

ontac

t Len

s Soc

iety O

f Oph

thalm

ologis

ts A

ll righ

ts re

serve

d - A

ny re

prod

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n eve

n in p

art is

proh

ibited

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Cyclosporine A cationic emulsion 01 (Ikervisreg Santen)

bull Approved in Europe in 2015bull Main effect prolonged precorneal residence time and improved

bioavailabilityo Indicated for patients with severe DED that has not improved

using tear substitutesbull Clinical evidence of reduced HLA-DR expression at 6 mo measured

through impression cytology overall greater benefits for patients with Sjoumlgrenrsquos Syndrome1

1Leonardi A Messmer EM Labetoulle M et al Efficacy and safety of 01 ciclosporin A cationic emulsion in dry eye disease a pooled analysis of two double-masked randomised vehicle-controlled phase III clinical studies Br J Ophthalmol 2018

2018

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Cyclosporine 009 (OTX-101 CequaTM Sun Pharma)

bull FDA Approval Aug 2018

bull Highest FDA-approved concentration of cyclosporine A1

bull Main effect Increase tear production

bull Calcineurin inhibitor

bull Nanomicellar formulation eases entry into corneal and conjunctival cells

bull Two multicenter studies report a statistically significant increase (ge 10 mm) in Schirmer wetting at 3 mo in patients receiving CequaTM vs vehicle1

Cyclosporine - New Preparations

Biospacecom

1epgonlineorg ldquoFDA Approves CEQUA to Treat Dry Eye Syndrome- Sun Pharma + Sun Ophthalmicsrdquo Epgonlineorg Aug 2018 wwwepgonlineorgusnewsfda-approves-cequa-to-treat-dry-eye-syndrome---sun-pharma---sun--ophthalmics-html

2018

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Cyclosporine 005 and 01 (CyclASol Novaliq)

bull Semifluorinated alkanes formulation better dissolves Cyclosporine Abull Greater penetration than FDA-approved 005 Cyclosporine A

(Restasis)bull Evidence of decreased corneal and conjunctival staining after 14

days2

bull It remains unknown whether greater concentration leads to better results phase 3 studies are underway3

2Novaliq CyclASolreg ndash Cyclosporine in SFA for Ophthalmological Application to Treat Dry Eye Syndrome 20153 Lallemand F Shmitt M Bourges JL et al Cyclosporine A delivery to the eye a comprehensive review of academic and industrial efforts Eur J Pharm Biopharm 201711714-28

2018

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Cyclosporin with chondroiton sulphate

Klarity- C

Imprimis- compounded

chondroitin sulfate

2018

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SkQ1 bull Main effects synthesized small molecule targeted to reduce oxidative stress in cellmitochondria

o Regenerates itself o SkQ1 ophthalmic solution is indicated for pathologies of the eye associated with

oxidative stress such as dry eye 1

o Approved in Russia (2011) and marketed as Visomitinbull Clinical evidence suggest statistically significant 2

o Decrease in corneal stainingo Improvements in lid margin rednesso Improvements in symptoms measuredo through Ora CalibraTM scales

1Wakamatsu TH Dogru M Tsubota K Tearful relations oxidative stress inflammation and eye diseases Arq Bras Oftalmol 200871(6 Suppl)72ndash92Petrov Anton et al SkQ1 ophthalmic solution for dry eye treatment results of a phase 2 safety and efficacy clinical study in the environment and during challenge in the controlled adverse environment model Advances in therapy 331 (2016) 96-115

2018

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Steroids- new formulation bullKPI-121- Kala Pharmaceuticals

bullMucous ndash penetrating particle ( MPP) ndashbullnano particles

bullLoteprednol -025

bull Better penetration low dose steroid

bullEpisodic flare ups of DED

2018

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ADX-102 (Reproxalap Aldeyra Therapeutics)bull Small molecule topical agentbull Traps aldehydes that usually activate inflammatory factorsbull Positive clinical evidence of improvement in signs and

symptoms of dry eye1

Thymosin beta 4 (Tβ4 ) bull 43-amino acid G-actin binding proteinbull Downregulates transcription of inflammatory mediators and promotes corneal

epithelial cell migrationbull Phase 3 clinical trial with Tβ4 (RGN-259 RegeneRx) showed improvement in signs

and symptoms of dry eye through corneal staining tear production and expression of inflammatory factors2

1Aldehyde trap drug rapidly improves signs symptoms of dry eye disease American Academy of Ophthalmology (2017) httpswwwaaoorgheadlinealdehyde-trap-drug-rapidly-improves-signs-symptoms2Kim Chae Eun et al RGN-259 (thymosin β4) improves clinically important dry eye efficacies in comparison with prescription drugs in a dry eye model Scientific reports 81 (2018) 10500

Aldeyracom

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Tear Enhancements

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bull Currently approved in Japan and South Korea1

bull Main Effect Increase tear fluid and mucin secretion on the ocular surface through interaction with P2Y2 receptors in the conjunctiva

bull Evidence from clinical trials suggest diquafosol improves corneal staining more effectively than a comparable sodium hyaluronate solution2

Diquafosol Tetrasodium(3 Ophthalmic Solution)

1Koh Shizuka Clinical utility of 3 diquafosol ophthalmic solution in the treatment of dry eyes Clinical Ophthalmology (Auckland NZ) 9 (2015) 8652Takamura Etsuko et al A randomised double-masked comparison study of diquafosol versus sodium hyaluronate ophthalmic solutions in dry eye patients British Journal of Ophthalmology 9610 (2012) 1310-1315

Pubmedcom

Santencom

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Rebapimide

(2 Ophthalmic Solution)

bull Currently approved in Japanbull Main Effect stimulates mucin secretagogue activity in

cornea and conjunctivabull Clinical evidence suggests

o Statistically significant Improvement in corneal and conjunctival staining as well as in quality of life as well as in tear break-up time12

o Potential role in suppressing the expression of inflammatory proteins (Polyl)3

1 Kinoshita Shigeru et al Rebamipide (OPC-12759) in the treatment of dry eye a randomized double-masked multicenter placebo-controlled phase II study Ophthalmology11912 (2012) 2471-24782 Kashima Tomoyuki et al Rebamipide ophthalmic suspension for the treatment of dry eye syndrome a critical appraisal Clinical ophthalmology (Auckland NZ) 8 (2014) 10033Ueta Mayumi et al Rebamipide suppresses PolyI C-stimulated cytokine production in human conjunctival epithelial cells Journal of Ocular Pharmacology and Therapeutics 297 (2013) 688-693

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TrueTearreg Allerganbull FDA Clearancebull Main effect intranasal applicator sends

electrical currents to nerves that stimulate tear production

bull Evidence of improved Schirmer scores decreased symptoms and corneal and conjunctival staining at 6 mo Ocular comfort lasted for 3 hours following neurostimulationo Secondary effect intranasal application

promotes goblet cell mucin secretion which stabilizes the tear film1

Truetearcom

1Gumus K Schuetzle KL Pflugfelder SC Randomized controlled crossover trial comparing the impact of sham or intranasal tear neurostimulation on 654 GD Novack et al The Ocular Surface xxx (2017) 635e655 conjunctival goblet cell degranulation Am J Ophthalmol 2017177159e68

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Pharmaceutical to stimulate nerves

bullNasal Spray OC-01

bullOyster Point Pharma

bullStimulate natural tears

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Amniotic cytokine extract(Ocular Science)bullACE is a novel drop marketed as Genesis bullContains various cytokines growth factor

and anti-inflammatory moleculesbull Effective in a small pilot study

Amniotic Cytokine Extract Promising in Patients with Dry Ey Disease MDLinx

httpswwwmdlinxcomophthalmologyarticle1280 1113088 Accessed Jan 27 2018

Amniotic Cytokine Extract Promising in Patients with Dry Ey Disease MDLinx

httpswwwmdlinxcomophthalmologyarticle1280 1113088 Accessed Jan 27 2

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Recombinant human nerve growth factor (OxervateTM eye drops Dompeacute)

bull FDA Approval Aug 2018o First approved drug for Neurotropic keratitis (NK) ndashdegenerative disease with loss of corneal sensation o Topical eye drop o Clinical evidence of complete corneal healing in 70 of patients treated with Oxervate after 8 weeks1

1Bonini S et al Phase II Randomized Double-Masked Vehicle-Controlled Trial of Recombinant Human Nerve Growth Factor for Neurotrophic Keratitis Ophthalmology 125 1332ndash1343 (2018)

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Perfluorohexyloctane (NovaTears Novaliq)

bull Main effect prevent evaporative DED by increasing tear film and lipid layer thickness

bull Approved in Europe Australia and New Zealandbull Clinical evidence of increased tear production and tear film

stability as well as significant decrease in OSDI scores and in corneal staining1

1Steven P et al Semifluorinated Alkane Eye Drops for Treatment of Dry Eye Disease ndash A Prospective Multicenter Noninterventional Study J Ocul Pharmacol Ther 2015 Oct 1 31(8) 498-503

Corneal Epithelium Healing

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CrossThiolated Carboxymethyl Hyaluronic Acid Liquid-Gel

(Ocular Bandage Gel EyeGate Pharma)

bull Main effects accelerate corneal healing and reduce corneal stainingo Indicated for defects due to photorefcrative keratectomy (PRK)o Indicated for Punctate epitheliopathies (PE) associated with

dry eyebull Treatment in development July 2018 approval to conduct two

pilot studies using OBG for PE and PRKbull A first-in-human pilot study (n=39) showed accelerated corneal

reepithelialization through slit lamp examination at day 1 after PRK Further studies needed1

1Durrie Daniel S et al Ability of a new crosslinked polymer ocular bandage gel to accelerate reepithelialization after photorefractive keratectomy Journal of Cataract amp Refractive Surgery 443 (2018) 369-375

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Biologic MoleculesDry Eye Assessment

bull Proteoglycan-4 (Lubricin)oRecently discovered on the ocular surface in the meibomian glands2

oFunctions to prevent friction at the cornea-lid interface and has anti-inflammatory propertiesoCommercial lubricin-based lubricants remain scarceoEvidence from clinical studies with recombinant human lubricin suggest

significant improvement in signs and symptoms of DED through TBUT corneal staining and eyelid and conjunctival redness3

1De Paiva CS Chotikavanich S Pangelinan SB Pitcher 3rd JD Fang B Zheng X et al IL-17 disrupts corneal barrier following desiccating stress Mucosal Immunol 20092(3)243ndash2532Iqbal SM Leonard C Regmi SC De Rantere D Tailor P Ren G et al LubricinProteoglycan 4 binds to and regulates the activity of Toll-Like Receptors In Vitro Sci Rep20166189103Lambiase A Sullivan BD Schmidt TA Sullivan DA Jay GD Truitt ER et al A Two-Week Randomized Double-masked Study to Evaluate Safety and Efficacy of Lubricin

(150 mugmL) Eye Drops Versus Sodium Hyaluronate (HA) 018 Eye Drops (Vismed(R)) in Patients with Moderate Dry Eye Disease Ocul Surf 20171577ndash87

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Why Ocular Biomarkers

Surrogate Endpoints- None accepted by the FDA or Europe to date Validation needed- clear clinical relevance

Enrichment of Study Population Still regulatory hurdles

Support mechanism of action of treatment Topical ciclosporin in Europe for Dry eyes (Europe2015 Ikervis)1

SEGMENT THE DRY EYE POPULATION- TREAT MORE SPECIFICALLY-PERSONALIZE TREATMENT

1 Ikervis SmPC June 2015 available at httpswwwmedicinesorgukemcmedicine30584

2018

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NuLidstrade NuSight

bull Main effect lid scrub that stimulates Meibomian glands by removing biofilm and scurf that block the opening of the glands

bull Doctor-prescribed In-home treatmentbull 60 second daily treatmentbull A multi-center clinical study showed

evidence of 50 decrease in dry eye symptoms 65 improvement in TBUT and 81 improvement in Meibomian Gland liquid secretions1

1Schanzlin Olkowski Coble Gross NuLids II Study April 2018

2018

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TearCare System Sight Sciences

bull First wearable therapeutic eyelid therapy devicebull In-office treatmentbull 12 minute thermal eyelid treatment followed by expression forceps to

manually evacuate residual obstructionsbull Evidence from pilot study suggested improved TBUT corneal and

conjunctival staining scored and dry eye symptoms based on OSDI SPEED and SANDE1

bull Further clinical evidence underway

Badawi David A novel system TearCarereg for the treatment of the signs and symptoms of dry eye disease Clinical Ophthalmology (Auckland NZ) 12 (2018) 683

2018

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Anti-Inflammatory Pharmaceuticals

Cyclosporine

Main effectbull Anti-inflammatory therapy

bull Inhibits T-cell maturation

bull Decreases pro-inflammatory cytokines

bull Upregulates anti-inflammatory cytokines20

18 copy

48th

Europ

ean C

ontac

t Len

s Soc

iety O

f Oph

thalm

ologis

ts A

ll righ

ts re

serve

d - A

ny re

prod

uctio

n eve

n in p

art is

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ibited

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Cyclosporine A cationic emulsion 01 (Ikervisreg Santen)

bull Approved in Europe in 2015bull Main effect prolonged precorneal residence time and improved

bioavailabilityo Indicated for patients with severe DED that has not improved

using tear substitutesbull Clinical evidence of reduced HLA-DR expression at 6 mo measured

through impression cytology overall greater benefits for patients with Sjoumlgrenrsquos Syndrome1

1Leonardi A Messmer EM Labetoulle M et al Efficacy and safety of 01 ciclosporin A cationic emulsion in dry eye disease a pooled analysis of two double-masked randomised vehicle-controlled phase III clinical studies Br J Ophthalmol 2018

2018

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Cyclosporine 009 (OTX-101 CequaTM Sun Pharma)

bull FDA Approval Aug 2018

bull Highest FDA-approved concentration of cyclosporine A1

bull Main effect Increase tear production

bull Calcineurin inhibitor

bull Nanomicellar formulation eases entry into corneal and conjunctival cells

bull Two multicenter studies report a statistically significant increase (ge 10 mm) in Schirmer wetting at 3 mo in patients receiving CequaTM vs vehicle1

Cyclosporine - New Preparations

Biospacecom

1epgonlineorg ldquoFDA Approves CEQUA to Treat Dry Eye Syndrome- Sun Pharma + Sun Ophthalmicsrdquo Epgonlineorg Aug 2018 wwwepgonlineorgusnewsfda-approves-cequa-to-treat-dry-eye-syndrome---sun-pharma---sun--ophthalmics-html

2018

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Cyclosporine 005 and 01 (CyclASol Novaliq)

bull Semifluorinated alkanes formulation better dissolves Cyclosporine Abull Greater penetration than FDA-approved 005 Cyclosporine A

(Restasis)bull Evidence of decreased corneal and conjunctival staining after 14

days2

bull It remains unknown whether greater concentration leads to better results phase 3 studies are underway3

2Novaliq CyclASolreg ndash Cyclosporine in SFA for Ophthalmological Application to Treat Dry Eye Syndrome 20153 Lallemand F Shmitt M Bourges JL et al Cyclosporine A delivery to the eye a comprehensive review of academic and industrial efforts Eur J Pharm Biopharm 201711714-28

2018

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Cyclosporin with chondroiton sulphate

Klarity- C

Imprimis- compounded

chondroitin sulfate

2018

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SkQ1 bull Main effects synthesized small molecule targeted to reduce oxidative stress in cellmitochondria

o Regenerates itself o SkQ1 ophthalmic solution is indicated for pathologies of the eye associated with

oxidative stress such as dry eye 1

o Approved in Russia (2011) and marketed as Visomitinbull Clinical evidence suggest statistically significant 2

o Decrease in corneal stainingo Improvements in lid margin rednesso Improvements in symptoms measuredo through Ora CalibraTM scales

1Wakamatsu TH Dogru M Tsubota K Tearful relations oxidative stress inflammation and eye diseases Arq Bras Oftalmol 200871(6 Suppl)72ndash92Petrov Anton et al SkQ1 ophthalmic solution for dry eye treatment results of a phase 2 safety and efficacy clinical study in the environment and during challenge in the controlled adverse environment model Advances in therapy 331 (2016) 96-115

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Steroids- new formulation bullKPI-121- Kala Pharmaceuticals

bullMucous ndash penetrating particle ( MPP) ndashbullnano particles

bullLoteprednol -025

bull Better penetration low dose steroid

bullEpisodic flare ups of DED

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ADX-102 (Reproxalap Aldeyra Therapeutics)bull Small molecule topical agentbull Traps aldehydes that usually activate inflammatory factorsbull Positive clinical evidence of improvement in signs and

symptoms of dry eye1

Thymosin beta 4 (Tβ4 ) bull 43-amino acid G-actin binding proteinbull Downregulates transcription of inflammatory mediators and promotes corneal

epithelial cell migrationbull Phase 3 clinical trial with Tβ4 (RGN-259 RegeneRx) showed improvement in signs

and symptoms of dry eye through corneal staining tear production and expression of inflammatory factors2

1Aldehyde trap drug rapidly improves signs symptoms of dry eye disease American Academy of Ophthalmology (2017) httpswwwaaoorgheadlinealdehyde-trap-drug-rapidly-improves-signs-symptoms2Kim Chae Eun et al RGN-259 (thymosin β4) improves clinically important dry eye efficacies in comparison with prescription drugs in a dry eye model Scientific reports 81 (2018) 10500

Aldeyracom

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Tear Enhancements

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bull Currently approved in Japan and South Korea1

bull Main Effect Increase tear fluid and mucin secretion on the ocular surface through interaction with P2Y2 receptors in the conjunctiva

bull Evidence from clinical trials suggest diquafosol improves corneal staining more effectively than a comparable sodium hyaluronate solution2

Diquafosol Tetrasodium(3 Ophthalmic Solution)

1Koh Shizuka Clinical utility of 3 diquafosol ophthalmic solution in the treatment of dry eyes Clinical Ophthalmology (Auckland NZ) 9 (2015) 8652Takamura Etsuko et al A randomised double-masked comparison study of diquafosol versus sodium hyaluronate ophthalmic solutions in dry eye patients British Journal of Ophthalmology 9610 (2012) 1310-1315

Pubmedcom

Santencom

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Rebapimide

(2 Ophthalmic Solution)

bull Currently approved in Japanbull Main Effect stimulates mucin secretagogue activity in

cornea and conjunctivabull Clinical evidence suggests

o Statistically significant Improvement in corneal and conjunctival staining as well as in quality of life as well as in tear break-up time12

o Potential role in suppressing the expression of inflammatory proteins (Polyl)3

1 Kinoshita Shigeru et al Rebamipide (OPC-12759) in the treatment of dry eye a randomized double-masked multicenter placebo-controlled phase II study Ophthalmology11912 (2012) 2471-24782 Kashima Tomoyuki et al Rebamipide ophthalmic suspension for the treatment of dry eye syndrome a critical appraisal Clinical ophthalmology (Auckland NZ) 8 (2014) 10033Ueta Mayumi et al Rebamipide suppresses PolyI C-stimulated cytokine production in human conjunctival epithelial cells Journal of Ocular Pharmacology and Therapeutics 297 (2013) 688-693

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TrueTearreg Allerganbull FDA Clearancebull Main effect intranasal applicator sends

electrical currents to nerves that stimulate tear production

bull Evidence of improved Schirmer scores decreased symptoms and corneal and conjunctival staining at 6 mo Ocular comfort lasted for 3 hours following neurostimulationo Secondary effect intranasal application

promotes goblet cell mucin secretion which stabilizes the tear film1

Truetearcom

1Gumus K Schuetzle KL Pflugfelder SC Randomized controlled crossover trial comparing the impact of sham or intranasal tear neurostimulation on 654 GD Novack et al The Ocular Surface xxx (2017) 635e655 conjunctival goblet cell degranulation Am J Ophthalmol 2017177159e68

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Pharmaceutical to stimulate nerves

bullNasal Spray OC-01

bullOyster Point Pharma

bullStimulate natural tears

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Amniotic cytokine extract(Ocular Science)bullACE is a novel drop marketed as Genesis bullContains various cytokines growth factor

and anti-inflammatory moleculesbull Effective in a small pilot study

Amniotic Cytokine Extract Promising in Patients with Dry Ey Disease MDLinx

httpswwwmdlinxcomophthalmologyarticle1280 1113088 Accessed Jan 27 2018

Amniotic Cytokine Extract Promising in Patients with Dry Ey Disease MDLinx

httpswwwmdlinxcomophthalmologyarticle1280 1113088 Accessed Jan 27 2

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Recombinant human nerve growth factor (OxervateTM eye drops Dompeacute)

bull FDA Approval Aug 2018o First approved drug for Neurotropic keratitis (NK) ndashdegenerative disease with loss of corneal sensation o Topical eye drop o Clinical evidence of complete corneal healing in 70 of patients treated with Oxervate after 8 weeks1

1Bonini S et al Phase II Randomized Double-Masked Vehicle-Controlled Trial of Recombinant Human Nerve Growth Factor for Neurotrophic Keratitis Ophthalmology 125 1332ndash1343 (2018)

2018

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Perfluorohexyloctane (NovaTears Novaliq)

bull Main effect prevent evaporative DED by increasing tear film and lipid layer thickness

bull Approved in Europe Australia and New Zealandbull Clinical evidence of increased tear production and tear film

stability as well as significant decrease in OSDI scores and in corneal staining1

1Steven P et al Semifluorinated Alkane Eye Drops for Treatment of Dry Eye Disease ndash A Prospective Multicenter Noninterventional Study J Ocul Pharmacol Ther 2015 Oct 1 31(8) 498-503

Corneal Epithelium Healing

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CrossThiolated Carboxymethyl Hyaluronic Acid Liquid-Gel

(Ocular Bandage Gel EyeGate Pharma)

bull Main effects accelerate corneal healing and reduce corneal stainingo Indicated for defects due to photorefcrative keratectomy (PRK)o Indicated for Punctate epitheliopathies (PE) associated with

dry eyebull Treatment in development July 2018 approval to conduct two

pilot studies using OBG for PE and PRKbull A first-in-human pilot study (n=39) showed accelerated corneal

reepithelialization through slit lamp examination at day 1 after PRK Further studies needed1

1Durrie Daniel S et al Ability of a new crosslinked polymer ocular bandage gel to accelerate reepithelialization after photorefractive keratectomy Journal of Cataract amp Refractive Surgery 443 (2018) 369-375

2018

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Biologic MoleculesDry Eye Assessment

bull Proteoglycan-4 (Lubricin)oRecently discovered on the ocular surface in the meibomian glands2

oFunctions to prevent friction at the cornea-lid interface and has anti-inflammatory propertiesoCommercial lubricin-based lubricants remain scarceoEvidence from clinical studies with recombinant human lubricin suggest

significant improvement in signs and symptoms of DED through TBUT corneal staining and eyelid and conjunctival redness3

1De Paiva CS Chotikavanich S Pangelinan SB Pitcher 3rd JD Fang B Zheng X et al IL-17 disrupts corneal barrier following desiccating stress Mucosal Immunol 20092(3)243ndash2532Iqbal SM Leonard C Regmi SC De Rantere D Tailor P Ren G et al LubricinProteoglycan 4 binds to and regulates the activity of Toll-Like Receptors In Vitro Sci Rep20166189103Lambiase A Sullivan BD Schmidt TA Sullivan DA Jay GD Truitt ER et al A Two-Week Randomized Double-masked Study to Evaluate Safety and Efficacy of Lubricin

(150 mugmL) Eye Drops Versus Sodium Hyaluronate (HA) 018 Eye Drops (Vismed(R)) in Patients with Moderate Dry Eye Disease Ocul Surf 20171577ndash87

2018

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Why Ocular Biomarkers

Surrogate Endpoints- None accepted by the FDA or Europe to date Validation needed- clear clinical relevance

Enrichment of Study Population Still regulatory hurdles

Support mechanism of action of treatment Topical ciclosporin in Europe for Dry eyes (Europe2015 Ikervis)1

SEGMENT THE DRY EYE POPULATION- TREAT MORE SPECIFICALLY-PERSONALIZE TREATMENT

1 Ikervis SmPC June 2015 available at httpswwwmedicinesorgukemcmedicine30584

2018

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TearCare System Sight Sciences

bull First wearable therapeutic eyelid therapy devicebull In-office treatmentbull 12 minute thermal eyelid treatment followed by expression forceps to

manually evacuate residual obstructionsbull Evidence from pilot study suggested improved TBUT corneal and

conjunctival staining scored and dry eye symptoms based on OSDI SPEED and SANDE1

bull Further clinical evidence underway

Badawi David A novel system TearCarereg for the treatment of the signs and symptoms of dry eye disease Clinical Ophthalmology (Auckland NZ) 12 (2018) 683

2018

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Anti-Inflammatory Pharmaceuticals

Cyclosporine

Main effectbull Anti-inflammatory therapy

bull Inhibits T-cell maturation

bull Decreases pro-inflammatory cytokines

bull Upregulates anti-inflammatory cytokines20

18 copy

48th

Europ

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ontac

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s Soc

iety O

f Oph

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ll righ

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d - A

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art is

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Cyclosporine A cationic emulsion 01 (Ikervisreg Santen)

bull Approved in Europe in 2015bull Main effect prolonged precorneal residence time and improved

bioavailabilityo Indicated for patients with severe DED that has not improved

using tear substitutesbull Clinical evidence of reduced HLA-DR expression at 6 mo measured

through impression cytology overall greater benefits for patients with Sjoumlgrenrsquos Syndrome1

1Leonardi A Messmer EM Labetoulle M et al Efficacy and safety of 01 ciclosporin A cationic emulsion in dry eye disease a pooled analysis of two double-masked randomised vehicle-controlled phase III clinical studies Br J Ophthalmol 2018

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Cyclosporine 009 (OTX-101 CequaTM Sun Pharma)

bull FDA Approval Aug 2018

bull Highest FDA-approved concentration of cyclosporine A1

bull Main effect Increase tear production

bull Calcineurin inhibitor

bull Nanomicellar formulation eases entry into corneal and conjunctival cells

bull Two multicenter studies report a statistically significant increase (ge 10 mm) in Schirmer wetting at 3 mo in patients receiving CequaTM vs vehicle1

Cyclosporine - New Preparations

Biospacecom

1epgonlineorg ldquoFDA Approves CEQUA to Treat Dry Eye Syndrome- Sun Pharma + Sun Ophthalmicsrdquo Epgonlineorg Aug 2018 wwwepgonlineorgusnewsfda-approves-cequa-to-treat-dry-eye-syndrome---sun-pharma---sun--ophthalmics-html

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Cyclosporine 005 and 01 (CyclASol Novaliq)

bull Semifluorinated alkanes formulation better dissolves Cyclosporine Abull Greater penetration than FDA-approved 005 Cyclosporine A

(Restasis)bull Evidence of decreased corneal and conjunctival staining after 14

days2

bull It remains unknown whether greater concentration leads to better results phase 3 studies are underway3

2Novaliq CyclASolreg ndash Cyclosporine in SFA for Ophthalmological Application to Treat Dry Eye Syndrome 20153 Lallemand F Shmitt M Bourges JL et al Cyclosporine A delivery to the eye a comprehensive review of academic and industrial efforts Eur J Pharm Biopharm 201711714-28

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Cyclosporin with chondroiton sulphate

Klarity- C

Imprimis- compounded

chondroitin sulfate

2018

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SkQ1 bull Main effects synthesized small molecule targeted to reduce oxidative stress in cellmitochondria

o Regenerates itself o SkQ1 ophthalmic solution is indicated for pathologies of the eye associated with

oxidative stress such as dry eye 1

o Approved in Russia (2011) and marketed as Visomitinbull Clinical evidence suggest statistically significant 2

o Decrease in corneal stainingo Improvements in lid margin rednesso Improvements in symptoms measuredo through Ora CalibraTM scales

1Wakamatsu TH Dogru M Tsubota K Tearful relations oxidative stress inflammation and eye diseases Arq Bras Oftalmol 200871(6 Suppl)72ndash92Petrov Anton et al SkQ1 ophthalmic solution for dry eye treatment results of a phase 2 safety and efficacy clinical study in the environment and during challenge in the controlled adverse environment model Advances in therapy 331 (2016) 96-115

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Steroids- new formulation bullKPI-121- Kala Pharmaceuticals

bullMucous ndash penetrating particle ( MPP) ndashbullnano particles

bullLoteprednol -025

bull Better penetration low dose steroid

bullEpisodic flare ups of DED

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ADX-102 (Reproxalap Aldeyra Therapeutics)bull Small molecule topical agentbull Traps aldehydes that usually activate inflammatory factorsbull Positive clinical evidence of improvement in signs and

symptoms of dry eye1

Thymosin beta 4 (Tβ4 ) bull 43-amino acid G-actin binding proteinbull Downregulates transcription of inflammatory mediators and promotes corneal

epithelial cell migrationbull Phase 3 clinical trial with Tβ4 (RGN-259 RegeneRx) showed improvement in signs

and symptoms of dry eye through corneal staining tear production and expression of inflammatory factors2

1Aldehyde trap drug rapidly improves signs symptoms of dry eye disease American Academy of Ophthalmology (2017) httpswwwaaoorgheadlinealdehyde-trap-drug-rapidly-improves-signs-symptoms2Kim Chae Eun et al RGN-259 (thymosin β4) improves clinically important dry eye efficacies in comparison with prescription drugs in a dry eye model Scientific reports 81 (2018) 10500

Aldeyracom

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Tear Enhancements

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bull Currently approved in Japan and South Korea1

bull Main Effect Increase tear fluid and mucin secretion on the ocular surface through interaction with P2Y2 receptors in the conjunctiva

bull Evidence from clinical trials suggest diquafosol improves corneal staining more effectively than a comparable sodium hyaluronate solution2

Diquafosol Tetrasodium(3 Ophthalmic Solution)

1Koh Shizuka Clinical utility of 3 diquafosol ophthalmic solution in the treatment of dry eyes Clinical Ophthalmology (Auckland NZ) 9 (2015) 8652Takamura Etsuko et al A randomised double-masked comparison study of diquafosol versus sodium hyaluronate ophthalmic solutions in dry eye patients British Journal of Ophthalmology 9610 (2012) 1310-1315

Pubmedcom

Santencom

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Rebapimide

(2 Ophthalmic Solution)

bull Currently approved in Japanbull Main Effect stimulates mucin secretagogue activity in

cornea and conjunctivabull Clinical evidence suggests

o Statistically significant Improvement in corneal and conjunctival staining as well as in quality of life as well as in tear break-up time12

o Potential role in suppressing the expression of inflammatory proteins (Polyl)3

1 Kinoshita Shigeru et al Rebamipide (OPC-12759) in the treatment of dry eye a randomized double-masked multicenter placebo-controlled phase II study Ophthalmology11912 (2012) 2471-24782 Kashima Tomoyuki et al Rebamipide ophthalmic suspension for the treatment of dry eye syndrome a critical appraisal Clinical ophthalmology (Auckland NZ) 8 (2014) 10033Ueta Mayumi et al Rebamipide suppresses PolyI C-stimulated cytokine production in human conjunctival epithelial cells Journal of Ocular Pharmacology and Therapeutics 297 (2013) 688-693

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TrueTearreg Allerganbull FDA Clearancebull Main effect intranasal applicator sends

electrical currents to nerves that stimulate tear production

bull Evidence of improved Schirmer scores decreased symptoms and corneal and conjunctival staining at 6 mo Ocular comfort lasted for 3 hours following neurostimulationo Secondary effect intranasal application

promotes goblet cell mucin secretion which stabilizes the tear film1

Truetearcom

1Gumus K Schuetzle KL Pflugfelder SC Randomized controlled crossover trial comparing the impact of sham or intranasal tear neurostimulation on 654 GD Novack et al The Ocular Surface xxx (2017) 635e655 conjunctival goblet cell degranulation Am J Ophthalmol 2017177159e68

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Pharmaceutical to stimulate nerves

bullNasal Spray OC-01

bullOyster Point Pharma

bullStimulate natural tears

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Amniotic cytokine extract(Ocular Science)bullACE is a novel drop marketed as Genesis bullContains various cytokines growth factor

and anti-inflammatory moleculesbull Effective in a small pilot study

Amniotic Cytokine Extract Promising in Patients with Dry Ey Disease MDLinx

httpswwwmdlinxcomophthalmologyarticle1280 1113088 Accessed Jan 27 2018

Amniotic Cytokine Extract Promising in Patients with Dry Ey Disease MDLinx

httpswwwmdlinxcomophthalmologyarticle1280 1113088 Accessed Jan 27 2

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Recombinant human nerve growth factor (OxervateTM eye drops Dompeacute)

bull FDA Approval Aug 2018o First approved drug for Neurotropic keratitis (NK) ndashdegenerative disease with loss of corneal sensation o Topical eye drop o Clinical evidence of complete corneal healing in 70 of patients treated with Oxervate after 8 weeks1

1Bonini S et al Phase II Randomized Double-Masked Vehicle-Controlled Trial of Recombinant Human Nerve Growth Factor for Neurotrophic Keratitis Ophthalmology 125 1332ndash1343 (2018)

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Perfluorohexyloctane (NovaTears Novaliq)

bull Main effect prevent evaporative DED by increasing tear film and lipid layer thickness

bull Approved in Europe Australia and New Zealandbull Clinical evidence of increased tear production and tear film

stability as well as significant decrease in OSDI scores and in corneal staining1

1Steven P et al Semifluorinated Alkane Eye Drops for Treatment of Dry Eye Disease ndash A Prospective Multicenter Noninterventional Study J Ocul Pharmacol Ther 2015 Oct 1 31(8) 498-503

Corneal Epithelium Healing

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CrossThiolated Carboxymethyl Hyaluronic Acid Liquid-Gel

(Ocular Bandage Gel EyeGate Pharma)

bull Main effects accelerate corneal healing and reduce corneal stainingo Indicated for defects due to photorefcrative keratectomy (PRK)o Indicated for Punctate epitheliopathies (PE) associated with

dry eyebull Treatment in development July 2018 approval to conduct two

pilot studies using OBG for PE and PRKbull A first-in-human pilot study (n=39) showed accelerated corneal

reepithelialization through slit lamp examination at day 1 after PRK Further studies needed1

1Durrie Daniel S et al Ability of a new crosslinked polymer ocular bandage gel to accelerate reepithelialization after photorefractive keratectomy Journal of Cataract amp Refractive Surgery 443 (2018) 369-375

2018

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Biologic MoleculesDry Eye Assessment

bull Proteoglycan-4 (Lubricin)oRecently discovered on the ocular surface in the meibomian glands2

oFunctions to prevent friction at the cornea-lid interface and has anti-inflammatory propertiesoCommercial lubricin-based lubricants remain scarceoEvidence from clinical studies with recombinant human lubricin suggest

significant improvement in signs and symptoms of DED through TBUT corneal staining and eyelid and conjunctival redness3

1De Paiva CS Chotikavanich S Pangelinan SB Pitcher 3rd JD Fang B Zheng X et al IL-17 disrupts corneal barrier following desiccating stress Mucosal Immunol 20092(3)243ndash2532Iqbal SM Leonard C Regmi SC De Rantere D Tailor P Ren G et al LubricinProteoglycan 4 binds to and regulates the activity of Toll-Like Receptors In Vitro Sci Rep20166189103Lambiase A Sullivan BD Schmidt TA Sullivan DA Jay GD Truitt ER et al A Two-Week Randomized Double-masked Study to Evaluate Safety and Efficacy of Lubricin

(150 mugmL) Eye Drops Versus Sodium Hyaluronate (HA) 018 Eye Drops (Vismed(R)) in Patients with Moderate Dry Eye Disease Ocul Surf 20171577ndash87

2018

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Why Ocular Biomarkers

Surrogate Endpoints- None accepted by the FDA or Europe to date Validation needed- clear clinical relevance

Enrichment of Study Population Still regulatory hurdles

Support mechanism of action of treatment Topical ciclosporin in Europe for Dry eyes (Europe2015 Ikervis)1

SEGMENT THE DRY EYE POPULATION- TREAT MORE SPECIFICALLY-PERSONALIZE TREATMENT

1 Ikervis SmPC June 2015 available at httpswwwmedicinesorgukemcmedicine30584

2018

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Anti-Inflammatory Pharmaceuticals

Cyclosporine

Main effectbull Anti-inflammatory therapy

bull Inhibits T-cell maturation

bull Decreases pro-inflammatory cytokines

bull Upregulates anti-inflammatory cytokines20

18 copy

48th

Europ

ean C

ontac

t Len

s Soc

iety O

f Oph

thalm

ologis

ts A

ll righ

ts re

serve

d - A

ny re

prod

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n in p

art is

proh

ibited

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Cyclosporine A cationic emulsion 01 (Ikervisreg Santen)

bull Approved in Europe in 2015bull Main effect prolonged precorneal residence time and improved

bioavailabilityo Indicated for patients with severe DED that has not improved

using tear substitutesbull Clinical evidence of reduced HLA-DR expression at 6 mo measured

through impression cytology overall greater benefits for patients with Sjoumlgrenrsquos Syndrome1

1Leonardi A Messmer EM Labetoulle M et al Efficacy and safety of 01 ciclosporin A cationic emulsion in dry eye disease a pooled analysis of two double-masked randomised vehicle-controlled phase III clinical studies Br J Ophthalmol 2018

2018

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Cyclosporine 009 (OTX-101 CequaTM Sun Pharma)

bull FDA Approval Aug 2018

bull Highest FDA-approved concentration of cyclosporine A1

bull Main effect Increase tear production

bull Calcineurin inhibitor

bull Nanomicellar formulation eases entry into corneal and conjunctival cells

bull Two multicenter studies report a statistically significant increase (ge 10 mm) in Schirmer wetting at 3 mo in patients receiving CequaTM vs vehicle1

Cyclosporine - New Preparations

Biospacecom

1epgonlineorg ldquoFDA Approves CEQUA to Treat Dry Eye Syndrome- Sun Pharma + Sun Ophthalmicsrdquo Epgonlineorg Aug 2018 wwwepgonlineorgusnewsfda-approves-cequa-to-treat-dry-eye-syndrome---sun-pharma---sun--ophthalmics-html

2018

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Cyclosporine 005 and 01 (CyclASol Novaliq)

bull Semifluorinated alkanes formulation better dissolves Cyclosporine Abull Greater penetration than FDA-approved 005 Cyclosporine A

(Restasis)bull Evidence of decreased corneal and conjunctival staining after 14

days2

bull It remains unknown whether greater concentration leads to better results phase 3 studies are underway3

2Novaliq CyclASolreg ndash Cyclosporine in SFA for Ophthalmological Application to Treat Dry Eye Syndrome 20153 Lallemand F Shmitt M Bourges JL et al Cyclosporine A delivery to the eye a comprehensive review of academic and industrial efforts Eur J Pharm Biopharm 201711714-28

2018

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Cyclosporin with chondroiton sulphate

Klarity- C

Imprimis- compounded

chondroitin sulfate

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SkQ1 bull Main effects synthesized small molecule targeted to reduce oxidative stress in cellmitochondria

o Regenerates itself o SkQ1 ophthalmic solution is indicated for pathologies of the eye associated with

oxidative stress such as dry eye 1

o Approved in Russia (2011) and marketed as Visomitinbull Clinical evidence suggest statistically significant 2

o Decrease in corneal stainingo Improvements in lid margin rednesso Improvements in symptoms measuredo through Ora CalibraTM scales

1Wakamatsu TH Dogru M Tsubota K Tearful relations oxidative stress inflammation and eye diseases Arq Bras Oftalmol 200871(6 Suppl)72ndash92Petrov Anton et al SkQ1 ophthalmic solution for dry eye treatment results of a phase 2 safety and efficacy clinical study in the environment and during challenge in the controlled adverse environment model Advances in therapy 331 (2016) 96-115

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Steroids- new formulation bullKPI-121- Kala Pharmaceuticals

bullMucous ndash penetrating particle ( MPP) ndashbullnano particles

bullLoteprednol -025

bull Better penetration low dose steroid

bullEpisodic flare ups of DED

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ADX-102 (Reproxalap Aldeyra Therapeutics)bull Small molecule topical agentbull Traps aldehydes that usually activate inflammatory factorsbull Positive clinical evidence of improvement in signs and

symptoms of dry eye1

Thymosin beta 4 (Tβ4 ) bull 43-amino acid G-actin binding proteinbull Downregulates transcription of inflammatory mediators and promotes corneal

epithelial cell migrationbull Phase 3 clinical trial with Tβ4 (RGN-259 RegeneRx) showed improvement in signs

and symptoms of dry eye through corneal staining tear production and expression of inflammatory factors2

1Aldehyde trap drug rapidly improves signs symptoms of dry eye disease American Academy of Ophthalmology (2017) httpswwwaaoorgheadlinealdehyde-trap-drug-rapidly-improves-signs-symptoms2Kim Chae Eun et al RGN-259 (thymosin β4) improves clinically important dry eye efficacies in comparison with prescription drugs in a dry eye model Scientific reports 81 (2018) 10500

Aldeyracom

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Tear Enhancements

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bull Currently approved in Japan and South Korea1

bull Main Effect Increase tear fluid and mucin secretion on the ocular surface through interaction with P2Y2 receptors in the conjunctiva

bull Evidence from clinical trials suggest diquafosol improves corneal staining more effectively than a comparable sodium hyaluronate solution2

Diquafosol Tetrasodium(3 Ophthalmic Solution)

1Koh Shizuka Clinical utility of 3 diquafosol ophthalmic solution in the treatment of dry eyes Clinical Ophthalmology (Auckland NZ) 9 (2015) 8652Takamura Etsuko et al A randomised double-masked comparison study of diquafosol versus sodium hyaluronate ophthalmic solutions in dry eye patients British Journal of Ophthalmology 9610 (2012) 1310-1315

Pubmedcom

Santencom

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Rebapimide

(2 Ophthalmic Solution)

bull Currently approved in Japanbull Main Effect stimulates mucin secretagogue activity in

cornea and conjunctivabull Clinical evidence suggests

o Statistically significant Improvement in corneal and conjunctival staining as well as in quality of life as well as in tear break-up time12

o Potential role in suppressing the expression of inflammatory proteins (Polyl)3

1 Kinoshita Shigeru et al Rebamipide (OPC-12759) in the treatment of dry eye a randomized double-masked multicenter placebo-controlled phase II study Ophthalmology11912 (2012) 2471-24782 Kashima Tomoyuki et al Rebamipide ophthalmic suspension for the treatment of dry eye syndrome a critical appraisal Clinical ophthalmology (Auckland NZ) 8 (2014) 10033Ueta Mayumi et al Rebamipide suppresses PolyI C-stimulated cytokine production in human conjunctival epithelial cells Journal of Ocular Pharmacology and Therapeutics 297 (2013) 688-693

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TrueTearreg Allerganbull FDA Clearancebull Main effect intranasal applicator sends

electrical currents to nerves that stimulate tear production

bull Evidence of improved Schirmer scores decreased symptoms and corneal and conjunctival staining at 6 mo Ocular comfort lasted for 3 hours following neurostimulationo Secondary effect intranasal application

promotes goblet cell mucin secretion which stabilizes the tear film1

Truetearcom

1Gumus K Schuetzle KL Pflugfelder SC Randomized controlled crossover trial comparing the impact of sham or intranasal tear neurostimulation on 654 GD Novack et al The Ocular Surface xxx (2017) 635e655 conjunctival goblet cell degranulation Am J Ophthalmol 2017177159e68

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Pharmaceutical to stimulate nerves

bullNasal Spray OC-01

bullOyster Point Pharma

bullStimulate natural tears

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Amniotic cytokine extract(Ocular Science)bullACE is a novel drop marketed as Genesis bullContains various cytokines growth factor

and anti-inflammatory moleculesbull Effective in a small pilot study

Amniotic Cytokine Extract Promising in Patients with Dry Ey Disease MDLinx

httpswwwmdlinxcomophthalmologyarticle1280 1113088 Accessed Jan 27 2018

Amniotic Cytokine Extract Promising in Patients with Dry Ey Disease MDLinx

httpswwwmdlinxcomophthalmologyarticle1280 1113088 Accessed Jan 27 2

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Recombinant human nerve growth factor (OxervateTM eye drops Dompeacute)

bull FDA Approval Aug 2018o First approved drug for Neurotropic keratitis (NK) ndashdegenerative disease with loss of corneal sensation o Topical eye drop o Clinical evidence of complete corneal healing in 70 of patients treated with Oxervate after 8 weeks1

1Bonini S et al Phase II Randomized Double-Masked Vehicle-Controlled Trial of Recombinant Human Nerve Growth Factor for Neurotrophic Keratitis Ophthalmology 125 1332ndash1343 (2018)

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Perfluorohexyloctane (NovaTears Novaliq)

bull Main effect prevent evaporative DED by increasing tear film and lipid layer thickness

bull Approved in Europe Australia and New Zealandbull Clinical evidence of increased tear production and tear film

stability as well as significant decrease in OSDI scores and in corneal staining1

1Steven P et al Semifluorinated Alkane Eye Drops for Treatment of Dry Eye Disease ndash A Prospective Multicenter Noninterventional Study J Ocul Pharmacol Ther 2015 Oct 1 31(8) 498-503

Corneal Epithelium Healing

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CrossThiolated Carboxymethyl Hyaluronic Acid Liquid-Gel

(Ocular Bandage Gel EyeGate Pharma)

bull Main effects accelerate corneal healing and reduce corneal stainingo Indicated for defects due to photorefcrative keratectomy (PRK)o Indicated for Punctate epitheliopathies (PE) associated with

dry eyebull Treatment in development July 2018 approval to conduct two

pilot studies using OBG for PE and PRKbull A first-in-human pilot study (n=39) showed accelerated corneal

reepithelialization through slit lamp examination at day 1 after PRK Further studies needed1

1Durrie Daniel S et al Ability of a new crosslinked polymer ocular bandage gel to accelerate reepithelialization after photorefractive keratectomy Journal of Cataract amp Refractive Surgery 443 (2018) 369-375

2018

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Biologic MoleculesDry Eye Assessment

bull Proteoglycan-4 (Lubricin)oRecently discovered on the ocular surface in the meibomian glands2

oFunctions to prevent friction at the cornea-lid interface and has anti-inflammatory propertiesoCommercial lubricin-based lubricants remain scarceoEvidence from clinical studies with recombinant human lubricin suggest

significant improvement in signs and symptoms of DED through TBUT corneal staining and eyelid and conjunctival redness3

1De Paiva CS Chotikavanich S Pangelinan SB Pitcher 3rd JD Fang B Zheng X et al IL-17 disrupts corneal barrier following desiccating stress Mucosal Immunol 20092(3)243ndash2532Iqbal SM Leonard C Regmi SC De Rantere D Tailor P Ren G et al LubricinProteoglycan 4 binds to and regulates the activity of Toll-Like Receptors In Vitro Sci Rep20166189103Lambiase A Sullivan BD Schmidt TA Sullivan DA Jay GD Truitt ER et al A Two-Week Randomized Double-masked Study to Evaluate Safety and Efficacy of Lubricin

(150 mugmL) Eye Drops Versus Sodium Hyaluronate (HA) 018 Eye Drops (Vismed(R)) in Patients with Moderate Dry Eye Disease Ocul Surf 20171577ndash87

2018

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Why Ocular Biomarkers

Surrogate Endpoints- None accepted by the FDA or Europe to date Validation needed- clear clinical relevance

Enrichment of Study Population Still regulatory hurdles

Support mechanism of action of treatment Topical ciclosporin in Europe for Dry eyes (Europe2015 Ikervis)1

SEGMENT THE DRY EYE POPULATION- TREAT MORE SPECIFICALLY-PERSONALIZE TREATMENT

1 Ikervis SmPC June 2015 available at httpswwwmedicinesorgukemcmedicine30584

2018

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Cyclosporine A cationic emulsion 01 (Ikervisreg Santen)

bull Approved in Europe in 2015bull Main effect prolonged precorneal residence time and improved

bioavailabilityo Indicated for patients with severe DED that has not improved

using tear substitutesbull Clinical evidence of reduced HLA-DR expression at 6 mo measured

through impression cytology overall greater benefits for patients with Sjoumlgrenrsquos Syndrome1

1Leonardi A Messmer EM Labetoulle M et al Efficacy and safety of 01 ciclosporin A cationic emulsion in dry eye disease a pooled analysis of two double-masked randomised vehicle-controlled phase III clinical studies Br J Ophthalmol 2018

2018

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Cyclosporine 009 (OTX-101 CequaTM Sun Pharma)

bull FDA Approval Aug 2018

bull Highest FDA-approved concentration of cyclosporine A1

bull Main effect Increase tear production

bull Calcineurin inhibitor

bull Nanomicellar formulation eases entry into corneal and conjunctival cells

bull Two multicenter studies report a statistically significant increase (ge 10 mm) in Schirmer wetting at 3 mo in patients receiving CequaTM vs vehicle1

Cyclosporine - New Preparations

Biospacecom

1epgonlineorg ldquoFDA Approves CEQUA to Treat Dry Eye Syndrome- Sun Pharma + Sun Ophthalmicsrdquo Epgonlineorg Aug 2018 wwwepgonlineorgusnewsfda-approves-cequa-to-treat-dry-eye-syndrome---sun-pharma---sun--ophthalmics-html

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Cyclosporine 005 and 01 (CyclASol Novaliq)

bull Semifluorinated alkanes formulation better dissolves Cyclosporine Abull Greater penetration than FDA-approved 005 Cyclosporine A

(Restasis)bull Evidence of decreased corneal and conjunctival staining after 14

days2

bull It remains unknown whether greater concentration leads to better results phase 3 studies are underway3

2Novaliq CyclASolreg ndash Cyclosporine in SFA for Ophthalmological Application to Treat Dry Eye Syndrome 20153 Lallemand F Shmitt M Bourges JL et al Cyclosporine A delivery to the eye a comprehensive review of academic and industrial efforts Eur J Pharm Biopharm 201711714-28

2018

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Cyclosporin with chondroiton sulphate

Klarity- C

Imprimis- compounded

chondroitin sulfate

2018

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SkQ1 bull Main effects synthesized small molecule targeted to reduce oxidative stress in cellmitochondria

o Regenerates itself o SkQ1 ophthalmic solution is indicated for pathologies of the eye associated with

oxidative stress such as dry eye 1

o Approved in Russia (2011) and marketed as Visomitinbull Clinical evidence suggest statistically significant 2

o Decrease in corneal stainingo Improvements in lid margin rednesso Improvements in symptoms measuredo through Ora CalibraTM scales

1Wakamatsu TH Dogru M Tsubota K Tearful relations oxidative stress inflammation and eye diseases Arq Bras Oftalmol 200871(6 Suppl)72ndash92Petrov Anton et al SkQ1 ophthalmic solution for dry eye treatment results of a phase 2 safety and efficacy clinical study in the environment and during challenge in the controlled adverse environment model Advances in therapy 331 (2016) 96-115

2018

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Steroids- new formulation bullKPI-121- Kala Pharmaceuticals

bullMucous ndash penetrating particle ( MPP) ndashbullnano particles

bullLoteprednol -025

bull Better penetration low dose steroid

bullEpisodic flare ups of DED

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ADX-102 (Reproxalap Aldeyra Therapeutics)bull Small molecule topical agentbull Traps aldehydes that usually activate inflammatory factorsbull Positive clinical evidence of improvement in signs and

symptoms of dry eye1

Thymosin beta 4 (Tβ4 ) bull 43-amino acid G-actin binding proteinbull Downregulates transcription of inflammatory mediators and promotes corneal

epithelial cell migrationbull Phase 3 clinical trial with Tβ4 (RGN-259 RegeneRx) showed improvement in signs

and symptoms of dry eye through corneal staining tear production and expression of inflammatory factors2

1Aldehyde trap drug rapidly improves signs symptoms of dry eye disease American Academy of Ophthalmology (2017) httpswwwaaoorgheadlinealdehyde-trap-drug-rapidly-improves-signs-symptoms2Kim Chae Eun et al RGN-259 (thymosin β4) improves clinically important dry eye efficacies in comparison with prescription drugs in a dry eye model Scientific reports 81 (2018) 10500

Aldeyracom

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Tear Enhancements

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bull Currently approved in Japan and South Korea1

bull Main Effect Increase tear fluid and mucin secretion on the ocular surface through interaction with P2Y2 receptors in the conjunctiva

bull Evidence from clinical trials suggest diquafosol improves corneal staining more effectively than a comparable sodium hyaluronate solution2

Diquafosol Tetrasodium(3 Ophthalmic Solution)

1Koh Shizuka Clinical utility of 3 diquafosol ophthalmic solution in the treatment of dry eyes Clinical Ophthalmology (Auckland NZ) 9 (2015) 8652Takamura Etsuko et al A randomised double-masked comparison study of diquafosol versus sodium hyaluronate ophthalmic solutions in dry eye patients British Journal of Ophthalmology 9610 (2012) 1310-1315

Pubmedcom

Santencom

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Rebapimide

(2 Ophthalmic Solution)

bull Currently approved in Japanbull Main Effect stimulates mucin secretagogue activity in

cornea and conjunctivabull Clinical evidence suggests

o Statistically significant Improvement in corneal and conjunctival staining as well as in quality of life as well as in tear break-up time12

o Potential role in suppressing the expression of inflammatory proteins (Polyl)3

1 Kinoshita Shigeru et al Rebamipide (OPC-12759) in the treatment of dry eye a randomized double-masked multicenter placebo-controlled phase II study Ophthalmology11912 (2012) 2471-24782 Kashima Tomoyuki et al Rebamipide ophthalmic suspension for the treatment of dry eye syndrome a critical appraisal Clinical ophthalmology (Auckland NZ) 8 (2014) 10033Ueta Mayumi et al Rebamipide suppresses PolyI C-stimulated cytokine production in human conjunctival epithelial cells Journal of Ocular Pharmacology and Therapeutics 297 (2013) 688-693

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TrueTearreg Allerganbull FDA Clearancebull Main effect intranasal applicator sends

electrical currents to nerves that stimulate tear production

bull Evidence of improved Schirmer scores decreased symptoms and corneal and conjunctival staining at 6 mo Ocular comfort lasted for 3 hours following neurostimulationo Secondary effect intranasal application

promotes goblet cell mucin secretion which stabilizes the tear film1

Truetearcom

1Gumus K Schuetzle KL Pflugfelder SC Randomized controlled crossover trial comparing the impact of sham or intranasal tear neurostimulation on 654 GD Novack et al The Ocular Surface xxx (2017) 635e655 conjunctival goblet cell degranulation Am J Ophthalmol 2017177159e68

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Pharmaceutical to stimulate nerves

bullNasal Spray OC-01

bullOyster Point Pharma

bullStimulate natural tears

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Amniotic cytokine extract(Ocular Science)bullACE is a novel drop marketed as Genesis bullContains various cytokines growth factor

and anti-inflammatory moleculesbull Effective in a small pilot study

Amniotic Cytokine Extract Promising in Patients with Dry Ey Disease MDLinx

httpswwwmdlinxcomophthalmologyarticle1280 1113088 Accessed Jan 27 2018

Amniotic Cytokine Extract Promising in Patients with Dry Ey Disease MDLinx

httpswwwmdlinxcomophthalmologyarticle1280 1113088 Accessed Jan 27 2

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Recombinant human nerve growth factor (OxervateTM eye drops Dompeacute)

bull FDA Approval Aug 2018o First approved drug for Neurotropic keratitis (NK) ndashdegenerative disease with loss of corneal sensation o Topical eye drop o Clinical evidence of complete corneal healing in 70 of patients treated with Oxervate after 8 weeks1

1Bonini S et al Phase II Randomized Double-Masked Vehicle-Controlled Trial of Recombinant Human Nerve Growth Factor for Neurotrophic Keratitis Ophthalmology 125 1332ndash1343 (2018)

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Perfluorohexyloctane (NovaTears Novaliq)

bull Main effect prevent evaporative DED by increasing tear film and lipid layer thickness

bull Approved in Europe Australia and New Zealandbull Clinical evidence of increased tear production and tear film

stability as well as significant decrease in OSDI scores and in corneal staining1

1Steven P et al Semifluorinated Alkane Eye Drops for Treatment of Dry Eye Disease ndash A Prospective Multicenter Noninterventional Study J Ocul Pharmacol Ther 2015 Oct 1 31(8) 498-503

Corneal Epithelium Healing

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CrossThiolated Carboxymethyl Hyaluronic Acid Liquid-Gel

(Ocular Bandage Gel EyeGate Pharma)

bull Main effects accelerate corneal healing and reduce corneal stainingo Indicated for defects due to photorefcrative keratectomy (PRK)o Indicated for Punctate epitheliopathies (PE) associated with

dry eyebull Treatment in development July 2018 approval to conduct two

pilot studies using OBG for PE and PRKbull A first-in-human pilot study (n=39) showed accelerated corneal

reepithelialization through slit lamp examination at day 1 after PRK Further studies needed1

1Durrie Daniel S et al Ability of a new crosslinked polymer ocular bandage gel to accelerate reepithelialization after photorefractive keratectomy Journal of Cataract amp Refractive Surgery 443 (2018) 369-375

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Biologic MoleculesDry Eye Assessment

bull Proteoglycan-4 (Lubricin)oRecently discovered on the ocular surface in the meibomian glands2

oFunctions to prevent friction at the cornea-lid interface and has anti-inflammatory propertiesoCommercial lubricin-based lubricants remain scarceoEvidence from clinical studies with recombinant human lubricin suggest

significant improvement in signs and symptoms of DED through TBUT corneal staining and eyelid and conjunctival redness3

1De Paiva CS Chotikavanich S Pangelinan SB Pitcher 3rd JD Fang B Zheng X et al IL-17 disrupts corneal barrier following desiccating stress Mucosal Immunol 20092(3)243ndash2532Iqbal SM Leonard C Regmi SC De Rantere D Tailor P Ren G et al LubricinProteoglycan 4 binds to and regulates the activity of Toll-Like Receptors In Vitro Sci Rep20166189103Lambiase A Sullivan BD Schmidt TA Sullivan DA Jay GD Truitt ER et al A Two-Week Randomized Double-masked Study to Evaluate Safety and Efficacy of Lubricin

(150 mugmL) Eye Drops Versus Sodium Hyaluronate (HA) 018 Eye Drops (Vismed(R)) in Patients with Moderate Dry Eye Disease Ocul Surf 20171577ndash87

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Why Ocular Biomarkers

Surrogate Endpoints- None accepted by the FDA or Europe to date Validation needed- clear clinical relevance

Enrichment of Study Population Still regulatory hurdles

Support mechanism of action of treatment Topical ciclosporin in Europe for Dry eyes (Europe2015 Ikervis)1

SEGMENT THE DRY EYE POPULATION- TREAT MORE SPECIFICALLY-PERSONALIZE TREATMENT

1 Ikervis SmPC June 2015 available at httpswwwmedicinesorgukemcmedicine30584

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Cyclosporine 009 (OTX-101 CequaTM Sun Pharma)

bull FDA Approval Aug 2018

bull Highest FDA-approved concentration of cyclosporine A1

bull Main effect Increase tear production

bull Calcineurin inhibitor

bull Nanomicellar formulation eases entry into corneal and conjunctival cells

bull Two multicenter studies report a statistically significant increase (ge 10 mm) in Schirmer wetting at 3 mo in patients receiving CequaTM vs vehicle1

Cyclosporine - New Preparations

Biospacecom

1epgonlineorg ldquoFDA Approves CEQUA to Treat Dry Eye Syndrome- Sun Pharma + Sun Ophthalmicsrdquo Epgonlineorg Aug 2018 wwwepgonlineorgusnewsfda-approves-cequa-to-treat-dry-eye-syndrome---sun-pharma---sun--ophthalmics-html

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Cyclosporine 005 and 01 (CyclASol Novaliq)

bull Semifluorinated alkanes formulation better dissolves Cyclosporine Abull Greater penetration than FDA-approved 005 Cyclosporine A

(Restasis)bull Evidence of decreased corneal and conjunctival staining after 14

days2

bull It remains unknown whether greater concentration leads to better results phase 3 studies are underway3

2Novaliq CyclASolreg ndash Cyclosporine in SFA for Ophthalmological Application to Treat Dry Eye Syndrome 20153 Lallemand F Shmitt M Bourges JL et al Cyclosporine A delivery to the eye a comprehensive review of academic and industrial efforts Eur J Pharm Biopharm 201711714-28

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Cyclosporin with chondroiton sulphate

Klarity- C

Imprimis- compounded

chondroitin sulfate

2018

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SkQ1 bull Main effects synthesized small molecule targeted to reduce oxidative stress in cellmitochondria

o Regenerates itself o SkQ1 ophthalmic solution is indicated for pathologies of the eye associated with

oxidative stress such as dry eye 1

o Approved in Russia (2011) and marketed as Visomitinbull Clinical evidence suggest statistically significant 2

o Decrease in corneal stainingo Improvements in lid margin rednesso Improvements in symptoms measuredo through Ora CalibraTM scales

1Wakamatsu TH Dogru M Tsubota K Tearful relations oxidative stress inflammation and eye diseases Arq Bras Oftalmol 200871(6 Suppl)72ndash92Petrov Anton et al SkQ1 ophthalmic solution for dry eye treatment results of a phase 2 safety and efficacy clinical study in the environment and during challenge in the controlled adverse environment model Advances in therapy 331 (2016) 96-115

2018

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Steroids- new formulation bullKPI-121- Kala Pharmaceuticals

bullMucous ndash penetrating particle ( MPP) ndashbullnano particles

bullLoteprednol -025

bull Better penetration low dose steroid

bullEpisodic flare ups of DED

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ADX-102 (Reproxalap Aldeyra Therapeutics)bull Small molecule topical agentbull Traps aldehydes that usually activate inflammatory factorsbull Positive clinical evidence of improvement in signs and

symptoms of dry eye1

Thymosin beta 4 (Tβ4 ) bull 43-amino acid G-actin binding proteinbull Downregulates transcription of inflammatory mediators and promotes corneal

epithelial cell migrationbull Phase 3 clinical trial with Tβ4 (RGN-259 RegeneRx) showed improvement in signs

and symptoms of dry eye through corneal staining tear production and expression of inflammatory factors2

1Aldehyde trap drug rapidly improves signs symptoms of dry eye disease American Academy of Ophthalmology (2017) httpswwwaaoorgheadlinealdehyde-trap-drug-rapidly-improves-signs-symptoms2Kim Chae Eun et al RGN-259 (thymosin β4) improves clinically important dry eye efficacies in comparison with prescription drugs in a dry eye model Scientific reports 81 (2018) 10500

Aldeyracom

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Tear Enhancements

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bull Currently approved in Japan and South Korea1

bull Main Effect Increase tear fluid and mucin secretion on the ocular surface through interaction with P2Y2 receptors in the conjunctiva

bull Evidence from clinical trials suggest diquafosol improves corneal staining more effectively than a comparable sodium hyaluronate solution2

Diquafosol Tetrasodium(3 Ophthalmic Solution)

1Koh Shizuka Clinical utility of 3 diquafosol ophthalmic solution in the treatment of dry eyes Clinical Ophthalmology (Auckland NZ) 9 (2015) 8652Takamura Etsuko et al A randomised double-masked comparison study of diquafosol versus sodium hyaluronate ophthalmic solutions in dry eye patients British Journal of Ophthalmology 9610 (2012) 1310-1315

Pubmedcom

Santencom

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Rebapimide

(2 Ophthalmic Solution)

bull Currently approved in Japanbull Main Effect stimulates mucin secretagogue activity in

cornea and conjunctivabull Clinical evidence suggests

o Statistically significant Improvement in corneal and conjunctival staining as well as in quality of life as well as in tear break-up time12

o Potential role in suppressing the expression of inflammatory proteins (Polyl)3

1 Kinoshita Shigeru et al Rebamipide (OPC-12759) in the treatment of dry eye a randomized double-masked multicenter placebo-controlled phase II study Ophthalmology11912 (2012) 2471-24782 Kashima Tomoyuki et al Rebamipide ophthalmic suspension for the treatment of dry eye syndrome a critical appraisal Clinical ophthalmology (Auckland NZ) 8 (2014) 10033Ueta Mayumi et al Rebamipide suppresses PolyI C-stimulated cytokine production in human conjunctival epithelial cells Journal of Ocular Pharmacology and Therapeutics 297 (2013) 688-693

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TrueTearreg Allerganbull FDA Clearancebull Main effect intranasal applicator sends

electrical currents to nerves that stimulate tear production

bull Evidence of improved Schirmer scores decreased symptoms and corneal and conjunctival staining at 6 mo Ocular comfort lasted for 3 hours following neurostimulationo Secondary effect intranasal application

promotes goblet cell mucin secretion which stabilizes the tear film1

Truetearcom

1Gumus K Schuetzle KL Pflugfelder SC Randomized controlled crossover trial comparing the impact of sham or intranasal tear neurostimulation on 654 GD Novack et al The Ocular Surface xxx (2017) 635e655 conjunctival goblet cell degranulation Am J Ophthalmol 2017177159e68

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Pharmaceutical to stimulate nerves

bullNasal Spray OC-01

bullOyster Point Pharma

bullStimulate natural tears

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Amniotic cytokine extract(Ocular Science)bullACE is a novel drop marketed as Genesis bullContains various cytokines growth factor

and anti-inflammatory moleculesbull Effective in a small pilot study

Amniotic Cytokine Extract Promising in Patients with Dry Ey Disease MDLinx

httpswwwmdlinxcomophthalmologyarticle1280 1113088 Accessed Jan 27 2018

Amniotic Cytokine Extract Promising in Patients with Dry Ey Disease MDLinx

httpswwwmdlinxcomophthalmologyarticle1280 1113088 Accessed Jan 27 2

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Recombinant human nerve growth factor (OxervateTM eye drops Dompeacute)

bull FDA Approval Aug 2018o First approved drug for Neurotropic keratitis (NK) ndashdegenerative disease with loss of corneal sensation o Topical eye drop o Clinical evidence of complete corneal healing in 70 of patients treated with Oxervate after 8 weeks1

1Bonini S et al Phase II Randomized Double-Masked Vehicle-Controlled Trial of Recombinant Human Nerve Growth Factor for Neurotrophic Keratitis Ophthalmology 125 1332ndash1343 (2018)

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Perfluorohexyloctane (NovaTears Novaliq)

bull Main effect prevent evaporative DED by increasing tear film and lipid layer thickness

bull Approved in Europe Australia and New Zealandbull Clinical evidence of increased tear production and tear film

stability as well as significant decrease in OSDI scores and in corneal staining1

1Steven P et al Semifluorinated Alkane Eye Drops for Treatment of Dry Eye Disease ndash A Prospective Multicenter Noninterventional Study J Ocul Pharmacol Ther 2015 Oct 1 31(8) 498-503

Corneal Epithelium Healing

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CrossThiolated Carboxymethyl Hyaluronic Acid Liquid-Gel

(Ocular Bandage Gel EyeGate Pharma)

bull Main effects accelerate corneal healing and reduce corneal stainingo Indicated for defects due to photorefcrative keratectomy (PRK)o Indicated for Punctate epitheliopathies (PE) associated with

dry eyebull Treatment in development July 2018 approval to conduct two

pilot studies using OBG for PE and PRKbull A first-in-human pilot study (n=39) showed accelerated corneal

reepithelialization through slit lamp examination at day 1 after PRK Further studies needed1

1Durrie Daniel S et al Ability of a new crosslinked polymer ocular bandage gel to accelerate reepithelialization after photorefractive keratectomy Journal of Cataract amp Refractive Surgery 443 (2018) 369-375

2018

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Biologic MoleculesDry Eye Assessment

bull Proteoglycan-4 (Lubricin)oRecently discovered on the ocular surface in the meibomian glands2

oFunctions to prevent friction at the cornea-lid interface and has anti-inflammatory propertiesoCommercial lubricin-based lubricants remain scarceoEvidence from clinical studies with recombinant human lubricin suggest

significant improvement in signs and symptoms of DED through TBUT corneal staining and eyelid and conjunctival redness3

1De Paiva CS Chotikavanich S Pangelinan SB Pitcher 3rd JD Fang B Zheng X et al IL-17 disrupts corneal barrier following desiccating stress Mucosal Immunol 20092(3)243ndash2532Iqbal SM Leonard C Regmi SC De Rantere D Tailor P Ren G et al LubricinProteoglycan 4 binds to and regulates the activity of Toll-Like Receptors In Vitro Sci Rep20166189103Lambiase A Sullivan BD Schmidt TA Sullivan DA Jay GD Truitt ER et al A Two-Week Randomized Double-masked Study to Evaluate Safety and Efficacy of Lubricin

(150 mugmL) Eye Drops Versus Sodium Hyaluronate (HA) 018 Eye Drops (Vismed(R)) in Patients with Moderate Dry Eye Disease Ocul Surf 20171577ndash87

2018

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Why Ocular Biomarkers

Surrogate Endpoints- None accepted by the FDA or Europe to date Validation needed- clear clinical relevance

Enrichment of Study Population Still regulatory hurdles

Support mechanism of action of treatment Topical ciclosporin in Europe for Dry eyes (Europe2015 Ikervis)1

SEGMENT THE DRY EYE POPULATION- TREAT MORE SPECIFICALLY-PERSONALIZE TREATMENT

1 Ikervis SmPC June 2015 available at httpswwwmedicinesorgukemcmedicine30584

2018

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Cyclosporine 005 and 01 (CyclASol Novaliq)

bull Semifluorinated alkanes formulation better dissolves Cyclosporine Abull Greater penetration than FDA-approved 005 Cyclosporine A

(Restasis)bull Evidence of decreased corneal and conjunctival staining after 14

days2

bull It remains unknown whether greater concentration leads to better results phase 3 studies are underway3

2Novaliq CyclASolreg ndash Cyclosporine in SFA for Ophthalmological Application to Treat Dry Eye Syndrome 20153 Lallemand F Shmitt M Bourges JL et al Cyclosporine A delivery to the eye a comprehensive review of academic and industrial efforts Eur J Pharm Biopharm 201711714-28

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Cyclosporin with chondroiton sulphate

Klarity- C

Imprimis- compounded

chondroitin sulfate

2018

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SkQ1 bull Main effects synthesized small molecule targeted to reduce oxidative stress in cellmitochondria

o Regenerates itself o SkQ1 ophthalmic solution is indicated for pathologies of the eye associated with

oxidative stress such as dry eye 1

o Approved in Russia (2011) and marketed as Visomitinbull Clinical evidence suggest statistically significant 2

o Decrease in corneal stainingo Improvements in lid margin rednesso Improvements in symptoms measuredo through Ora CalibraTM scales

1Wakamatsu TH Dogru M Tsubota K Tearful relations oxidative stress inflammation and eye diseases Arq Bras Oftalmol 200871(6 Suppl)72ndash92Petrov Anton et al SkQ1 ophthalmic solution for dry eye treatment results of a phase 2 safety and efficacy clinical study in the environment and during challenge in the controlled adverse environment model Advances in therapy 331 (2016) 96-115

2018

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Steroids- new formulation bullKPI-121- Kala Pharmaceuticals

bullMucous ndash penetrating particle ( MPP) ndashbullnano particles

bullLoteprednol -025

bull Better penetration low dose steroid

bullEpisodic flare ups of DED

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ADX-102 (Reproxalap Aldeyra Therapeutics)bull Small molecule topical agentbull Traps aldehydes that usually activate inflammatory factorsbull Positive clinical evidence of improvement in signs and

symptoms of dry eye1

Thymosin beta 4 (Tβ4 ) bull 43-amino acid G-actin binding proteinbull Downregulates transcription of inflammatory mediators and promotes corneal

epithelial cell migrationbull Phase 3 clinical trial with Tβ4 (RGN-259 RegeneRx) showed improvement in signs

and symptoms of dry eye through corneal staining tear production and expression of inflammatory factors2

1Aldehyde trap drug rapidly improves signs symptoms of dry eye disease American Academy of Ophthalmology (2017) httpswwwaaoorgheadlinealdehyde-trap-drug-rapidly-improves-signs-symptoms2Kim Chae Eun et al RGN-259 (thymosin β4) improves clinically important dry eye efficacies in comparison with prescription drugs in a dry eye model Scientific reports 81 (2018) 10500

Aldeyracom

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Tear Enhancements

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bull Currently approved in Japan and South Korea1

bull Main Effect Increase tear fluid and mucin secretion on the ocular surface through interaction with P2Y2 receptors in the conjunctiva

bull Evidence from clinical trials suggest diquafosol improves corneal staining more effectively than a comparable sodium hyaluronate solution2

Diquafosol Tetrasodium(3 Ophthalmic Solution)

1Koh Shizuka Clinical utility of 3 diquafosol ophthalmic solution in the treatment of dry eyes Clinical Ophthalmology (Auckland NZ) 9 (2015) 8652Takamura Etsuko et al A randomised double-masked comparison study of diquafosol versus sodium hyaluronate ophthalmic solutions in dry eye patients British Journal of Ophthalmology 9610 (2012) 1310-1315

Pubmedcom

Santencom

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Rebapimide

(2 Ophthalmic Solution)

bull Currently approved in Japanbull Main Effect stimulates mucin secretagogue activity in

cornea and conjunctivabull Clinical evidence suggests

o Statistically significant Improvement in corneal and conjunctival staining as well as in quality of life as well as in tear break-up time12

o Potential role in suppressing the expression of inflammatory proteins (Polyl)3

1 Kinoshita Shigeru et al Rebamipide (OPC-12759) in the treatment of dry eye a randomized double-masked multicenter placebo-controlled phase II study Ophthalmology11912 (2012) 2471-24782 Kashima Tomoyuki et al Rebamipide ophthalmic suspension for the treatment of dry eye syndrome a critical appraisal Clinical ophthalmology (Auckland NZ) 8 (2014) 10033Ueta Mayumi et al Rebamipide suppresses PolyI C-stimulated cytokine production in human conjunctival epithelial cells Journal of Ocular Pharmacology and Therapeutics 297 (2013) 688-693

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TrueTearreg Allerganbull FDA Clearancebull Main effect intranasal applicator sends

electrical currents to nerves that stimulate tear production

bull Evidence of improved Schirmer scores decreased symptoms and corneal and conjunctival staining at 6 mo Ocular comfort lasted for 3 hours following neurostimulationo Secondary effect intranasal application

promotes goblet cell mucin secretion which stabilizes the tear film1

Truetearcom

1Gumus K Schuetzle KL Pflugfelder SC Randomized controlled crossover trial comparing the impact of sham or intranasal tear neurostimulation on 654 GD Novack et al The Ocular Surface xxx (2017) 635e655 conjunctival goblet cell degranulation Am J Ophthalmol 2017177159e68

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Pharmaceutical to stimulate nerves

bullNasal Spray OC-01

bullOyster Point Pharma

bullStimulate natural tears

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Amniotic cytokine extract(Ocular Science)bullACE is a novel drop marketed as Genesis bullContains various cytokines growth factor

and anti-inflammatory moleculesbull Effective in a small pilot study

Amniotic Cytokine Extract Promising in Patients with Dry Ey Disease MDLinx

httpswwwmdlinxcomophthalmologyarticle1280 1113088 Accessed Jan 27 2018

Amniotic Cytokine Extract Promising in Patients with Dry Ey Disease MDLinx

httpswwwmdlinxcomophthalmologyarticle1280 1113088 Accessed Jan 27 2

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Recombinant human nerve growth factor (OxervateTM eye drops Dompeacute)

bull FDA Approval Aug 2018o First approved drug for Neurotropic keratitis (NK) ndashdegenerative disease with loss of corneal sensation o Topical eye drop o Clinical evidence of complete corneal healing in 70 of patients treated with Oxervate after 8 weeks1

1Bonini S et al Phase II Randomized Double-Masked Vehicle-Controlled Trial of Recombinant Human Nerve Growth Factor for Neurotrophic Keratitis Ophthalmology 125 1332ndash1343 (2018)

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Perfluorohexyloctane (NovaTears Novaliq)

bull Main effect prevent evaporative DED by increasing tear film and lipid layer thickness

bull Approved in Europe Australia and New Zealandbull Clinical evidence of increased tear production and tear film

stability as well as significant decrease in OSDI scores and in corneal staining1

1Steven P et al Semifluorinated Alkane Eye Drops for Treatment of Dry Eye Disease ndash A Prospective Multicenter Noninterventional Study J Ocul Pharmacol Ther 2015 Oct 1 31(8) 498-503

Corneal Epithelium Healing

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CrossThiolated Carboxymethyl Hyaluronic Acid Liquid-Gel

(Ocular Bandage Gel EyeGate Pharma)

bull Main effects accelerate corneal healing and reduce corneal stainingo Indicated for defects due to photorefcrative keratectomy (PRK)o Indicated for Punctate epitheliopathies (PE) associated with

dry eyebull Treatment in development July 2018 approval to conduct two

pilot studies using OBG for PE and PRKbull A first-in-human pilot study (n=39) showed accelerated corneal

reepithelialization through slit lamp examination at day 1 after PRK Further studies needed1

1Durrie Daniel S et al Ability of a new crosslinked polymer ocular bandage gel to accelerate reepithelialization after photorefractive keratectomy Journal of Cataract amp Refractive Surgery 443 (2018) 369-375

2018

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Biologic MoleculesDry Eye Assessment

bull Proteoglycan-4 (Lubricin)oRecently discovered on the ocular surface in the meibomian glands2

oFunctions to prevent friction at the cornea-lid interface and has anti-inflammatory propertiesoCommercial lubricin-based lubricants remain scarceoEvidence from clinical studies with recombinant human lubricin suggest

significant improvement in signs and symptoms of DED through TBUT corneal staining and eyelid and conjunctival redness3

1De Paiva CS Chotikavanich S Pangelinan SB Pitcher 3rd JD Fang B Zheng X et al IL-17 disrupts corneal barrier following desiccating stress Mucosal Immunol 20092(3)243ndash2532Iqbal SM Leonard C Regmi SC De Rantere D Tailor P Ren G et al LubricinProteoglycan 4 binds to and regulates the activity of Toll-Like Receptors In Vitro Sci Rep20166189103Lambiase A Sullivan BD Schmidt TA Sullivan DA Jay GD Truitt ER et al A Two-Week Randomized Double-masked Study to Evaluate Safety and Efficacy of Lubricin

(150 mugmL) Eye Drops Versus Sodium Hyaluronate (HA) 018 Eye Drops (Vismed(R)) in Patients with Moderate Dry Eye Disease Ocul Surf 20171577ndash87

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Why Ocular Biomarkers

Surrogate Endpoints- None accepted by the FDA or Europe to date Validation needed- clear clinical relevance

Enrichment of Study Population Still regulatory hurdles

Support mechanism of action of treatment Topical ciclosporin in Europe for Dry eyes (Europe2015 Ikervis)1

SEGMENT THE DRY EYE POPULATION- TREAT MORE SPECIFICALLY-PERSONALIZE TREATMENT

1 Ikervis SmPC June 2015 available at httpswwwmedicinesorgukemcmedicine30584

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Cyclosporin with chondroiton sulphate

Klarity- C

Imprimis- compounded

chondroitin sulfate

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SkQ1 bull Main effects synthesized small molecule targeted to reduce oxidative stress in cellmitochondria

o Regenerates itself o SkQ1 ophthalmic solution is indicated for pathologies of the eye associated with

oxidative stress such as dry eye 1

o Approved in Russia (2011) and marketed as Visomitinbull Clinical evidence suggest statistically significant 2

o Decrease in corneal stainingo Improvements in lid margin rednesso Improvements in symptoms measuredo through Ora CalibraTM scales

1Wakamatsu TH Dogru M Tsubota K Tearful relations oxidative stress inflammation and eye diseases Arq Bras Oftalmol 200871(6 Suppl)72ndash92Petrov Anton et al SkQ1 ophthalmic solution for dry eye treatment results of a phase 2 safety and efficacy clinical study in the environment and during challenge in the controlled adverse environment model Advances in therapy 331 (2016) 96-115

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Steroids- new formulation bullKPI-121- Kala Pharmaceuticals

bullMucous ndash penetrating particle ( MPP) ndashbullnano particles

bullLoteprednol -025

bull Better penetration low dose steroid

bullEpisodic flare ups of DED

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ADX-102 (Reproxalap Aldeyra Therapeutics)bull Small molecule topical agentbull Traps aldehydes that usually activate inflammatory factorsbull Positive clinical evidence of improvement in signs and

symptoms of dry eye1

Thymosin beta 4 (Tβ4 ) bull 43-amino acid G-actin binding proteinbull Downregulates transcription of inflammatory mediators and promotes corneal

epithelial cell migrationbull Phase 3 clinical trial with Tβ4 (RGN-259 RegeneRx) showed improvement in signs

and symptoms of dry eye through corneal staining tear production and expression of inflammatory factors2

1Aldehyde trap drug rapidly improves signs symptoms of dry eye disease American Academy of Ophthalmology (2017) httpswwwaaoorgheadlinealdehyde-trap-drug-rapidly-improves-signs-symptoms2Kim Chae Eun et al RGN-259 (thymosin β4) improves clinically important dry eye efficacies in comparison with prescription drugs in a dry eye model Scientific reports 81 (2018) 10500

Aldeyracom

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Tear Enhancements

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bull Currently approved in Japan and South Korea1

bull Main Effect Increase tear fluid and mucin secretion on the ocular surface through interaction with P2Y2 receptors in the conjunctiva

bull Evidence from clinical trials suggest diquafosol improves corneal staining more effectively than a comparable sodium hyaluronate solution2

Diquafosol Tetrasodium(3 Ophthalmic Solution)

1Koh Shizuka Clinical utility of 3 diquafosol ophthalmic solution in the treatment of dry eyes Clinical Ophthalmology (Auckland NZ) 9 (2015) 8652Takamura Etsuko et al A randomised double-masked comparison study of diquafosol versus sodium hyaluronate ophthalmic solutions in dry eye patients British Journal of Ophthalmology 9610 (2012) 1310-1315

Pubmedcom

Santencom

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Rebapimide

(2 Ophthalmic Solution)

bull Currently approved in Japanbull Main Effect stimulates mucin secretagogue activity in

cornea and conjunctivabull Clinical evidence suggests

o Statistically significant Improvement in corneal and conjunctival staining as well as in quality of life as well as in tear break-up time12

o Potential role in suppressing the expression of inflammatory proteins (Polyl)3

1 Kinoshita Shigeru et al Rebamipide (OPC-12759) in the treatment of dry eye a randomized double-masked multicenter placebo-controlled phase II study Ophthalmology11912 (2012) 2471-24782 Kashima Tomoyuki et al Rebamipide ophthalmic suspension for the treatment of dry eye syndrome a critical appraisal Clinical ophthalmology (Auckland NZ) 8 (2014) 10033Ueta Mayumi et al Rebamipide suppresses PolyI C-stimulated cytokine production in human conjunctival epithelial cells Journal of Ocular Pharmacology and Therapeutics 297 (2013) 688-693

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TrueTearreg Allerganbull FDA Clearancebull Main effect intranasal applicator sends

electrical currents to nerves that stimulate tear production

bull Evidence of improved Schirmer scores decreased symptoms and corneal and conjunctival staining at 6 mo Ocular comfort lasted for 3 hours following neurostimulationo Secondary effect intranasal application

promotes goblet cell mucin secretion which stabilizes the tear film1

Truetearcom

1Gumus K Schuetzle KL Pflugfelder SC Randomized controlled crossover trial comparing the impact of sham or intranasal tear neurostimulation on 654 GD Novack et al The Ocular Surface xxx (2017) 635e655 conjunctival goblet cell degranulation Am J Ophthalmol 2017177159e68

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Pharmaceutical to stimulate nerves

bullNasal Spray OC-01

bullOyster Point Pharma

bullStimulate natural tears

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Amniotic cytokine extract(Ocular Science)bullACE is a novel drop marketed as Genesis bullContains various cytokines growth factor

and anti-inflammatory moleculesbull Effective in a small pilot study

Amniotic Cytokine Extract Promising in Patients with Dry Ey Disease MDLinx

httpswwwmdlinxcomophthalmologyarticle1280 1113088 Accessed Jan 27 2018

Amniotic Cytokine Extract Promising in Patients with Dry Ey Disease MDLinx

httpswwwmdlinxcomophthalmologyarticle1280 1113088 Accessed Jan 27 2

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Recombinant human nerve growth factor (OxervateTM eye drops Dompeacute)

bull FDA Approval Aug 2018o First approved drug for Neurotropic keratitis (NK) ndashdegenerative disease with loss of corneal sensation o Topical eye drop o Clinical evidence of complete corneal healing in 70 of patients treated with Oxervate after 8 weeks1

1Bonini S et al Phase II Randomized Double-Masked Vehicle-Controlled Trial of Recombinant Human Nerve Growth Factor for Neurotrophic Keratitis Ophthalmology 125 1332ndash1343 (2018)

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Perfluorohexyloctane (NovaTears Novaliq)

bull Main effect prevent evaporative DED by increasing tear film and lipid layer thickness

bull Approved in Europe Australia and New Zealandbull Clinical evidence of increased tear production and tear film

stability as well as significant decrease in OSDI scores and in corneal staining1

1Steven P et al Semifluorinated Alkane Eye Drops for Treatment of Dry Eye Disease ndash A Prospective Multicenter Noninterventional Study J Ocul Pharmacol Ther 2015 Oct 1 31(8) 498-503

Corneal Epithelium Healing

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CrossThiolated Carboxymethyl Hyaluronic Acid Liquid-Gel

(Ocular Bandage Gel EyeGate Pharma)

bull Main effects accelerate corneal healing and reduce corneal stainingo Indicated for defects due to photorefcrative keratectomy (PRK)o Indicated for Punctate epitheliopathies (PE) associated with

dry eyebull Treatment in development July 2018 approval to conduct two

pilot studies using OBG for PE and PRKbull A first-in-human pilot study (n=39) showed accelerated corneal

reepithelialization through slit lamp examination at day 1 after PRK Further studies needed1

1Durrie Daniel S et al Ability of a new crosslinked polymer ocular bandage gel to accelerate reepithelialization after photorefractive keratectomy Journal of Cataract amp Refractive Surgery 443 (2018) 369-375

2018

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Biologic MoleculesDry Eye Assessment

bull Proteoglycan-4 (Lubricin)oRecently discovered on the ocular surface in the meibomian glands2

oFunctions to prevent friction at the cornea-lid interface and has anti-inflammatory propertiesoCommercial lubricin-based lubricants remain scarceoEvidence from clinical studies with recombinant human lubricin suggest

significant improvement in signs and symptoms of DED through TBUT corneal staining and eyelid and conjunctival redness3

1De Paiva CS Chotikavanich S Pangelinan SB Pitcher 3rd JD Fang B Zheng X et al IL-17 disrupts corneal barrier following desiccating stress Mucosal Immunol 20092(3)243ndash2532Iqbal SM Leonard C Regmi SC De Rantere D Tailor P Ren G et al LubricinProteoglycan 4 binds to and regulates the activity of Toll-Like Receptors In Vitro Sci Rep20166189103Lambiase A Sullivan BD Schmidt TA Sullivan DA Jay GD Truitt ER et al A Two-Week Randomized Double-masked Study to Evaluate Safety and Efficacy of Lubricin

(150 mugmL) Eye Drops Versus Sodium Hyaluronate (HA) 018 Eye Drops (Vismed(R)) in Patients with Moderate Dry Eye Disease Ocul Surf 20171577ndash87

2018

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Why Ocular Biomarkers

Surrogate Endpoints- None accepted by the FDA or Europe to date Validation needed- clear clinical relevance

Enrichment of Study Population Still regulatory hurdles

Support mechanism of action of treatment Topical ciclosporin in Europe for Dry eyes (Europe2015 Ikervis)1

SEGMENT THE DRY EYE POPULATION- TREAT MORE SPECIFICALLY-PERSONALIZE TREATMENT

1 Ikervis SmPC June 2015 available at httpswwwmedicinesorgukemcmedicine30584

2018

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SkQ1 bull Main effects synthesized small molecule targeted to reduce oxidative stress in cellmitochondria

o Regenerates itself o SkQ1 ophthalmic solution is indicated for pathologies of the eye associated with

oxidative stress such as dry eye 1

o Approved in Russia (2011) and marketed as Visomitinbull Clinical evidence suggest statistically significant 2

o Decrease in corneal stainingo Improvements in lid margin rednesso Improvements in symptoms measuredo through Ora CalibraTM scales

1Wakamatsu TH Dogru M Tsubota K Tearful relations oxidative stress inflammation and eye diseases Arq Bras Oftalmol 200871(6 Suppl)72ndash92Petrov Anton et al SkQ1 ophthalmic solution for dry eye treatment results of a phase 2 safety and efficacy clinical study in the environment and during challenge in the controlled adverse environment model Advances in therapy 331 (2016) 96-115

2018

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Steroids- new formulation bullKPI-121- Kala Pharmaceuticals

bullMucous ndash penetrating particle ( MPP) ndashbullnano particles

bullLoteprednol -025

bull Better penetration low dose steroid

bullEpisodic flare ups of DED

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ADX-102 (Reproxalap Aldeyra Therapeutics)bull Small molecule topical agentbull Traps aldehydes that usually activate inflammatory factorsbull Positive clinical evidence of improvement in signs and

symptoms of dry eye1

Thymosin beta 4 (Tβ4 ) bull 43-amino acid G-actin binding proteinbull Downregulates transcription of inflammatory mediators and promotes corneal

epithelial cell migrationbull Phase 3 clinical trial with Tβ4 (RGN-259 RegeneRx) showed improvement in signs

and symptoms of dry eye through corneal staining tear production and expression of inflammatory factors2

1Aldehyde trap drug rapidly improves signs symptoms of dry eye disease American Academy of Ophthalmology (2017) httpswwwaaoorgheadlinealdehyde-trap-drug-rapidly-improves-signs-symptoms2Kim Chae Eun et al RGN-259 (thymosin β4) improves clinically important dry eye efficacies in comparison with prescription drugs in a dry eye model Scientific reports 81 (2018) 10500

Aldeyracom

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Tear Enhancements

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bull Currently approved in Japan and South Korea1

bull Main Effect Increase tear fluid and mucin secretion on the ocular surface through interaction with P2Y2 receptors in the conjunctiva

bull Evidence from clinical trials suggest diquafosol improves corneal staining more effectively than a comparable sodium hyaluronate solution2

Diquafosol Tetrasodium(3 Ophthalmic Solution)

1Koh Shizuka Clinical utility of 3 diquafosol ophthalmic solution in the treatment of dry eyes Clinical Ophthalmology (Auckland NZ) 9 (2015) 8652Takamura Etsuko et al A randomised double-masked comparison study of diquafosol versus sodium hyaluronate ophthalmic solutions in dry eye patients British Journal of Ophthalmology 9610 (2012) 1310-1315

Pubmedcom

Santencom

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Rebapimide

(2 Ophthalmic Solution)

bull Currently approved in Japanbull Main Effect stimulates mucin secretagogue activity in

cornea and conjunctivabull Clinical evidence suggests

o Statistically significant Improvement in corneal and conjunctival staining as well as in quality of life as well as in tear break-up time12

o Potential role in suppressing the expression of inflammatory proteins (Polyl)3

1 Kinoshita Shigeru et al Rebamipide (OPC-12759) in the treatment of dry eye a randomized double-masked multicenter placebo-controlled phase II study Ophthalmology11912 (2012) 2471-24782 Kashima Tomoyuki et al Rebamipide ophthalmic suspension for the treatment of dry eye syndrome a critical appraisal Clinical ophthalmology (Auckland NZ) 8 (2014) 10033Ueta Mayumi et al Rebamipide suppresses PolyI C-stimulated cytokine production in human conjunctival epithelial cells Journal of Ocular Pharmacology and Therapeutics 297 (2013) 688-693

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TrueTearreg Allerganbull FDA Clearancebull Main effect intranasal applicator sends

electrical currents to nerves that stimulate tear production

bull Evidence of improved Schirmer scores decreased symptoms and corneal and conjunctival staining at 6 mo Ocular comfort lasted for 3 hours following neurostimulationo Secondary effect intranasal application

promotes goblet cell mucin secretion which stabilizes the tear film1

Truetearcom

1Gumus K Schuetzle KL Pflugfelder SC Randomized controlled crossover trial comparing the impact of sham or intranasal tear neurostimulation on 654 GD Novack et al The Ocular Surface xxx (2017) 635e655 conjunctival goblet cell degranulation Am J Ophthalmol 2017177159e68

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Pharmaceutical to stimulate nerves

bullNasal Spray OC-01

bullOyster Point Pharma

bullStimulate natural tears

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Amniotic cytokine extract(Ocular Science)bullACE is a novel drop marketed as Genesis bullContains various cytokines growth factor

and anti-inflammatory moleculesbull Effective in a small pilot study

Amniotic Cytokine Extract Promising in Patients with Dry Ey Disease MDLinx

httpswwwmdlinxcomophthalmologyarticle1280 1113088 Accessed Jan 27 2018

Amniotic Cytokine Extract Promising in Patients with Dry Ey Disease MDLinx

httpswwwmdlinxcomophthalmologyarticle1280 1113088 Accessed Jan 27 2

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Recombinant human nerve growth factor (OxervateTM eye drops Dompeacute)

bull FDA Approval Aug 2018o First approved drug for Neurotropic keratitis (NK) ndashdegenerative disease with loss of corneal sensation o Topical eye drop o Clinical evidence of complete corneal healing in 70 of patients treated with Oxervate after 8 weeks1

1Bonini S et al Phase II Randomized Double-Masked Vehicle-Controlled Trial of Recombinant Human Nerve Growth Factor for Neurotrophic Keratitis Ophthalmology 125 1332ndash1343 (2018)

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Perfluorohexyloctane (NovaTears Novaliq)

bull Main effect prevent evaporative DED by increasing tear film and lipid layer thickness

bull Approved in Europe Australia and New Zealandbull Clinical evidence of increased tear production and tear film

stability as well as significant decrease in OSDI scores and in corneal staining1

1Steven P et al Semifluorinated Alkane Eye Drops for Treatment of Dry Eye Disease ndash A Prospective Multicenter Noninterventional Study J Ocul Pharmacol Ther 2015 Oct 1 31(8) 498-503

Corneal Epithelium Healing

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CrossThiolated Carboxymethyl Hyaluronic Acid Liquid-Gel

(Ocular Bandage Gel EyeGate Pharma)

bull Main effects accelerate corneal healing and reduce corneal stainingo Indicated for defects due to photorefcrative keratectomy (PRK)o Indicated for Punctate epitheliopathies (PE) associated with

dry eyebull Treatment in development July 2018 approval to conduct two

pilot studies using OBG for PE and PRKbull A first-in-human pilot study (n=39) showed accelerated corneal

reepithelialization through slit lamp examination at day 1 after PRK Further studies needed1

1Durrie Daniel S et al Ability of a new crosslinked polymer ocular bandage gel to accelerate reepithelialization after photorefractive keratectomy Journal of Cataract amp Refractive Surgery 443 (2018) 369-375

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Biologic MoleculesDry Eye Assessment

bull Proteoglycan-4 (Lubricin)oRecently discovered on the ocular surface in the meibomian glands2

oFunctions to prevent friction at the cornea-lid interface and has anti-inflammatory propertiesoCommercial lubricin-based lubricants remain scarceoEvidence from clinical studies with recombinant human lubricin suggest

significant improvement in signs and symptoms of DED through TBUT corneal staining and eyelid and conjunctival redness3

1De Paiva CS Chotikavanich S Pangelinan SB Pitcher 3rd JD Fang B Zheng X et al IL-17 disrupts corneal barrier following desiccating stress Mucosal Immunol 20092(3)243ndash2532Iqbal SM Leonard C Regmi SC De Rantere D Tailor P Ren G et al LubricinProteoglycan 4 binds to and regulates the activity of Toll-Like Receptors In Vitro Sci Rep20166189103Lambiase A Sullivan BD Schmidt TA Sullivan DA Jay GD Truitt ER et al A Two-Week Randomized Double-masked Study to Evaluate Safety and Efficacy of Lubricin

(150 mugmL) Eye Drops Versus Sodium Hyaluronate (HA) 018 Eye Drops (Vismed(R)) in Patients with Moderate Dry Eye Disease Ocul Surf 20171577ndash87

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Why Ocular Biomarkers

Surrogate Endpoints- None accepted by the FDA or Europe to date Validation needed- clear clinical relevance

Enrichment of Study Population Still regulatory hurdles

Support mechanism of action of treatment Topical ciclosporin in Europe for Dry eyes (Europe2015 Ikervis)1

SEGMENT THE DRY EYE POPULATION- TREAT MORE SPECIFICALLY-PERSONALIZE TREATMENT

1 Ikervis SmPC June 2015 available at httpswwwmedicinesorgukemcmedicine30584

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Steroids- new formulation bullKPI-121- Kala Pharmaceuticals

bullMucous ndash penetrating particle ( MPP) ndashbullnano particles

bullLoteprednol -025

bull Better penetration low dose steroid

bullEpisodic flare ups of DED

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ADX-102 (Reproxalap Aldeyra Therapeutics)bull Small molecule topical agentbull Traps aldehydes that usually activate inflammatory factorsbull Positive clinical evidence of improvement in signs and

symptoms of dry eye1

Thymosin beta 4 (Tβ4 ) bull 43-amino acid G-actin binding proteinbull Downregulates transcription of inflammatory mediators and promotes corneal

epithelial cell migrationbull Phase 3 clinical trial with Tβ4 (RGN-259 RegeneRx) showed improvement in signs

and symptoms of dry eye through corneal staining tear production and expression of inflammatory factors2

1Aldehyde trap drug rapidly improves signs symptoms of dry eye disease American Academy of Ophthalmology (2017) httpswwwaaoorgheadlinealdehyde-trap-drug-rapidly-improves-signs-symptoms2Kim Chae Eun et al RGN-259 (thymosin β4) improves clinically important dry eye efficacies in comparison with prescription drugs in a dry eye model Scientific reports 81 (2018) 10500

Aldeyracom

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Tear Enhancements

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bull Currently approved in Japan and South Korea1

bull Main Effect Increase tear fluid and mucin secretion on the ocular surface through interaction with P2Y2 receptors in the conjunctiva

bull Evidence from clinical trials suggest diquafosol improves corneal staining more effectively than a comparable sodium hyaluronate solution2

Diquafosol Tetrasodium(3 Ophthalmic Solution)

1Koh Shizuka Clinical utility of 3 diquafosol ophthalmic solution in the treatment of dry eyes Clinical Ophthalmology (Auckland NZ) 9 (2015) 8652Takamura Etsuko et al A randomised double-masked comparison study of diquafosol versus sodium hyaluronate ophthalmic solutions in dry eye patients British Journal of Ophthalmology 9610 (2012) 1310-1315

Pubmedcom

Santencom

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Rebapimide

(2 Ophthalmic Solution)

bull Currently approved in Japanbull Main Effect stimulates mucin secretagogue activity in

cornea and conjunctivabull Clinical evidence suggests

o Statistically significant Improvement in corneal and conjunctival staining as well as in quality of life as well as in tear break-up time12

o Potential role in suppressing the expression of inflammatory proteins (Polyl)3

1 Kinoshita Shigeru et al Rebamipide (OPC-12759) in the treatment of dry eye a randomized double-masked multicenter placebo-controlled phase II study Ophthalmology11912 (2012) 2471-24782 Kashima Tomoyuki et al Rebamipide ophthalmic suspension for the treatment of dry eye syndrome a critical appraisal Clinical ophthalmology (Auckland NZ) 8 (2014) 10033Ueta Mayumi et al Rebamipide suppresses PolyI C-stimulated cytokine production in human conjunctival epithelial cells Journal of Ocular Pharmacology and Therapeutics 297 (2013) 688-693

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TrueTearreg Allerganbull FDA Clearancebull Main effect intranasal applicator sends

electrical currents to nerves that stimulate tear production

bull Evidence of improved Schirmer scores decreased symptoms and corneal and conjunctival staining at 6 mo Ocular comfort lasted for 3 hours following neurostimulationo Secondary effect intranasal application

promotes goblet cell mucin secretion which stabilizes the tear film1

Truetearcom

1Gumus K Schuetzle KL Pflugfelder SC Randomized controlled crossover trial comparing the impact of sham or intranasal tear neurostimulation on 654 GD Novack et al The Ocular Surface xxx (2017) 635e655 conjunctival goblet cell degranulation Am J Ophthalmol 2017177159e68

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Pharmaceutical to stimulate nerves

bullNasal Spray OC-01

bullOyster Point Pharma

bullStimulate natural tears

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Amniotic cytokine extract(Ocular Science)bullACE is a novel drop marketed as Genesis bullContains various cytokines growth factor

and anti-inflammatory moleculesbull Effective in a small pilot study

Amniotic Cytokine Extract Promising in Patients with Dry Ey Disease MDLinx

httpswwwmdlinxcomophthalmologyarticle1280 1113088 Accessed Jan 27 2018

Amniotic Cytokine Extract Promising in Patients with Dry Ey Disease MDLinx

httpswwwmdlinxcomophthalmologyarticle1280 1113088 Accessed Jan 27 2

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Recombinant human nerve growth factor (OxervateTM eye drops Dompeacute)

bull FDA Approval Aug 2018o First approved drug for Neurotropic keratitis (NK) ndashdegenerative disease with loss of corneal sensation o Topical eye drop o Clinical evidence of complete corneal healing in 70 of patients treated with Oxervate after 8 weeks1

1Bonini S et al Phase II Randomized Double-Masked Vehicle-Controlled Trial of Recombinant Human Nerve Growth Factor for Neurotrophic Keratitis Ophthalmology 125 1332ndash1343 (2018)

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Perfluorohexyloctane (NovaTears Novaliq)

bull Main effect prevent evaporative DED by increasing tear film and lipid layer thickness

bull Approved in Europe Australia and New Zealandbull Clinical evidence of increased tear production and tear film

stability as well as significant decrease in OSDI scores and in corneal staining1

1Steven P et al Semifluorinated Alkane Eye Drops for Treatment of Dry Eye Disease ndash A Prospective Multicenter Noninterventional Study J Ocul Pharmacol Ther 2015 Oct 1 31(8) 498-503

Corneal Epithelium Healing

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CrossThiolated Carboxymethyl Hyaluronic Acid Liquid-Gel

(Ocular Bandage Gel EyeGate Pharma)

bull Main effects accelerate corneal healing and reduce corneal stainingo Indicated for defects due to photorefcrative keratectomy (PRK)o Indicated for Punctate epitheliopathies (PE) associated with

dry eyebull Treatment in development July 2018 approval to conduct two

pilot studies using OBG for PE and PRKbull A first-in-human pilot study (n=39) showed accelerated corneal

reepithelialization through slit lamp examination at day 1 after PRK Further studies needed1

1Durrie Daniel S et al Ability of a new crosslinked polymer ocular bandage gel to accelerate reepithelialization after photorefractive keratectomy Journal of Cataract amp Refractive Surgery 443 (2018) 369-375

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Biologic MoleculesDry Eye Assessment

bull Proteoglycan-4 (Lubricin)oRecently discovered on the ocular surface in the meibomian glands2

oFunctions to prevent friction at the cornea-lid interface and has anti-inflammatory propertiesoCommercial lubricin-based lubricants remain scarceoEvidence from clinical studies with recombinant human lubricin suggest

significant improvement in signs and symptoms of DED through TBUT corneal staining and eyelid and conjunctival redness3

1De Paiva CS Chotikavanich S Pangelinan SB Pitcher 3rd JD Fang B Zheng X et al IL-17 disrupts corneal barrier following desiccating stress Mucosal Immunol 20092(3)243ndash2532Iqbal SM Leonard C Regmi SC De Rantere D Tailor P Ren G et al LubricinProteoglycan 4 binds to and regulates the activity of Toll-Like Receptors In Vitro Sci Rep20166189103Lambiase A Sullivan BD Schmidt TA Sullivan DA Jay GD Truitt ER et al A Two-Week Randomized Double-masked Study to Evaluate Safety and Efficacy of Lubricin

(150 mugmL) Eye Drops Versus Sodium Hyaluronate (HA) 018 Eye Drops (Vismed(R)) in Patients with Moderate Dry Eye Disease Ocul Surf 20171577ndash87

2018

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Why Ocular Biomarkers

Surrogate Endpoints- None accepted by the FDA or Europe to date Validation needed- clear clinical relevance

Enrichment of Study Population Still regulatory hurdles

Support mechanism of action of treatment Topical ciclosporin in Europe for Dry eyes (Europe2015 Ikervis)1

SEGMENT THE DRY EYE POPULATION- TREAT MORE SPECIFICALLY-PERSONALIZE TREATMENT

1 Ikervis SmPC June 2015 available at httpswwwmedicinesorgukemcmedicine30584

2018

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ADX-102 (Reproxalap Aldeyra Therapeutics)bull Small molecule topical agentbull Traps aldehydes that usually activate inflammatory factorsbull Positive clinical evidence of improvement in signs and

symptoms of dry eye1

Thymosin beta 4 (Tβ4 ) bull 43-amino acid G-actin binding proteinbull Downregulates transcription of inflammatory mediators and promotes corneal

epithelial cell migrationbull Phase 3 clinical trial with Tβ4 (RGN-259 RegeneRx) showed improvement in signs

and symptoms of dry eye through corneal staining tear production and expression of inflammatory factors2

1Aldehyde trap drug rapidly improves signs symptoms of dry eye disease American Academy of Ophthalmology (2017) httpswwwaaoorgheadlinealdehyde-trap-drug-rapidly-improves-signs-symptoms2Kim Chae Eun et al RGN-259 (thymosin β4) improves clinically important dry eye efficacies in comparison with prescription drugs in a dry eye model Scientific reports 81 (2018) 10500

Aldeyracom

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Tear Enhancements

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bull Currently approved in Japan and South Korea1

bull Main Effect Increase tear fluid and mucin secretion on the ocular surface through interaction with P2Y2 receptors in the conjunctiva

bull Evidence from clinical trials suggest diquafosol improves corneal staining more effectively than a comparable sodium hyaluronate solution2

Diquafosol Tetrasodium(3 Ophthalmic Solution)

1Koh Shizuka Clinical utility of 3 diquafosol ophthalmic solution in the treatment of dry eyes Clinical Ophthalmology (Auckland NZ) 9 (2015) 8652Takamura Etsuko et al A randomised double-masked comparison study of diquafosol versus sodium hyaluronate ophthalmic solutions in dry eye patients British Journal of Ophthalmology 9610 (2012) 1310-1315

Pubmedcom

Santencom

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Rebapimide

(2 Ophthalmic Solution)

bull Currently approved in Japanbull Main Effect stimulates mucin secretagogue activity in

cornea and conjunctivabull Clinical evidence suggests

o Statistically significant Improvement in corneal and conjunctival staining as well as in quality of life as well as in tear break-up time12

o Potential role in suppressing the expression of inflammatory proteins (Polyl)3

1 Kinoshita Shigeru et al Rebamipide (OPC-12759) in the treatment of dry eye a randomized double-masked multicenter placebo-controlled phase II study Ophthalmology11912 (2012) 2471-24782 Kashima Tomoyuki et al Rebamipide ophthalmic suspension for the treatment of dry eye syndrome a critical appraisal Clinical ophthalmology (Auckland NZ) 8 (2014) 10033Ueta Mayumi et al Rebamipide suppresses PolyI C-stimulated cytokine production in human conjunctival epithelial cells Journal of Ocular Pharmacology and Therapeutics 297 (2013) 688-693

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TrueTearreg Allerganbull FDA Clearancebull Main effect intranasal applicator sends

electrical currents to nerves that stimulate tear production

bull Evidence of improved Schirmer scores decreased symptoms and corneal and conjunctival staining at 6 mo Ocular comfort lasted for 3 hours following neurostimulationo Secondary effect intranasal application

promotes goblet cell mucin secretion which stabilizes the tear film1

Truetearcom

1Gumus K Schuetzle KL Pflugfelder SC Randomized controlled crossover trial comparing the impact of sham or intranasal tear neurostimulation on 654 GD Novack et al The Ocular Surface xxx (2017) 635e655 conjunctival goblet cell degranulation Am J Ophthalmol 2017177159e68

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Pharmaceutical to stimulate nerves

bullNasal Spray OC-01

bullOyster Point Pharma

bullStimulate natural tears

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Amniotic cytokine extract(Ocular Science)bullACE is a novel drop marketed as Genesis bullContains various cytokines growth factor

and anti-inflammatory moleculesbull Effective in a small pilot study

Amniotic Cytokine Extract Promising in Patients with Dry Ey Disease MDLinx

httpswwwmdlinxcomophthalmologyarticle1280 1113088 Accessed Jan 27 2018

Amniotic Cytokine Extract Promising in Patients with Dry Ey Disease MDLinx

httpswwwmdlinxcomophthalmologyarticle1280 1113088 Accessed Jan 27 2

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Recombinant human nerve growth factor (OxervateTM eye drops Dompeacute)

bull FDA Approval Aug 2018o First approved drug for Neurotropic keratitis (NK) ndashdegenerative disease with loss of corneal sensation o Topical eye drop o Clinical evidence of complete corneal healing in 70 of patients treated with Oxervate after 8 weeks1

1Bonini S et al Phase II Randomized Double-Masked Vehicle-Controlled Trial of Recombinant Human Nerve Growth Factor for Neurotrophic Keratitis Ophthalmology 125 1332ndash1343 (2018)

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Perfluorohexyloctane (NovaTears Novaliq)

bull Main effect prevent evaporative DED by increasing tear film and lipid layer thickness

bull Approved in Europe Australia and New Zealandbull Clinical evidence of increased tear production and tear film

stability as well as significant decrease in OSDI scores and in corneal staining1

1Steven P et al Semifluorinated Alkane Eye Drops for Treatment of Dry Eye Disease ndash A Prospective Multicenter Noninterventional Study J Ocul Pharmacol Ther 2015 Oct 1 31(8) 498-503

Corneal Epithelium Healing

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CrossThiolated Carboxymethyl Hyaluronic Acid Liquid-Gel

(Ocular Bandage Gel EyeGate Pharma)

bull Main effects accelerate corneal healing and reduce corneal stainingo Indicated for defects due to photorefcrative keratectomy (PRK)o Indicated for Punctate epitheliopathies (PE) associated with

dry eyebull Treatment in development July 2018 approval to conduct two

pilot studies using OBG for PE and PRKbull A first-in-human pilot study (n=39) showed accelerated corneal

reepithelialization through slit lamp examination at day 1 after PRK Further studies needed1

1Durrie Daniel S et al Ability of a new crosslinked polymer ocular bandage gel to accelerate reepithelialization after photorefractive keratectomy Journal of Cataract amp Refractive Surgery 443 (2018) 369-375

2018

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Biologic MoleculesDry Eye Assessment

bull Proteoglycan-4 (Lubricin)oRecently discovered on the ocular surface in the meibomian glands2

oFunctions to prevent friction at the cornea-lid interface and has anti-inflammatory propertiesoCommercial lubricin-based lubricants remain scarceoEvidence from clinical studies with recombinant human lubricin suggest

significant improvement in signs and symptoms of DED through TBUT corneal staining and eyelid and conjunctival redness3

1De Paiva CS Chotikavanich S Pangelinan SB Pitcher 3rd JD Fang B Zheng X et al IL-17 disrupts corneal barrier following desiccating stress Mucosal Immunol 20092(3)243ndash2532Iqbal SM Leonard C Regmi SC De Rantere D Tailor P Ren G et al LubricinProteoglycan 4 binds to and regulates the activity of Toll-Like Receptors In Vitro Sci Rep20166189103Lambiase A Sullivan BD Schmidt TA Sullivan DA Jay GD Truitt ER et al A Two-Week Randomized Double-masked Study to Evaluate Safety and Efficacy of Lubricin

(150 mugmL) Eye Drops Versus Sodium Hyaluronate (HA) 018 Eye Drops (Vismed(R)) in Patients with Moderate Dry Eye Disease Ocul Surf 20171577ndash87

2018

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Why Ocular Biomarkers

Surrogate Endpoints- None accepted by the FDA or Europe to date Validation needed- clear clinical relevance

Enrichment of Study Population Still regulatory hurdles

Support mechanism of action of treatment Topical ciclosporin in Europe for Dry eyes (Europe2015 Ikervis)1

SEGMENT THE DRY EYE POPULATION- TREAT MORE SPECIFICALLY-PERSONALIZE TREATMENT

1 Ikervis SmPC June 2015 available at httpswwwmedicinesorgukemcmedicine30584

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Tear Enhancements

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bull Currently approved in Japan and South Korea1

bull Main Effect Increase tear fluid and mucin secretion on the ocular surface through interaction with P2Y2 receptors in the conjunctiva

bull Evidence from clinical trials suggest diquafosol improves corneal staining more effectively than a comparable sodium hyaluronate solution2

Diquafosol Tetrasodium(3 Ophthalmic Solution)

1Koh Shizuka Clinical utility of 3 diquafosol ophthalmic solution in the treatment of dry eyes Clinical Ophthalmology (Auckland NZ) 9 (2015) 8652Takamura Etsuko et al A randomised double-masked comparison study of diquafosol versus sodium hyaluronate ophthalmic solutions in dry eye patients British Journal of Ophthalmology 9610 (2012) 1310-1315

Pubmedcom

Santencom

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Rebapimide

(2 Ophthalmic Solution)

bull Currently approved in Japanbull Main Effect stimulates mucin secretagogue activity in

cornea and conjunctivabull Clinical evidence suggests

o Statistically significant Improvement in corneal and conjunctival staining as well as in quality of life as well as in tear break-up time12

o Potential role in suppressing the expression of inflammatory proteins (Polyl)3

1 Kinoshita Shigeru et al Rebamipide (OPC-12759) in the treatment of dry eye a randomized double-masked multicenter placebo-controlled phase II study Ophthalmology11912 (2012) 2471-24782 Kashima Tomoyuki et al Rebamipide ophthalmic suspension for the treatment of dry eye syndrome a critical appraisal Clinical ophthalmology (Auckland NZ) 8 (2014) 10033Ueta Mayumi et al Rebamipide suppresses PolyI C-stimulated cytokine production in human conjunctival epithelial cells Journal of Ocular Pharmacology and Therapeutics 297 (2013) 688-693

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TrueTearreg Allerganbull FDA Clearancebull Main effect intranasal applicator sends

electrical currents to nerves that stimulate tear production

bull Evidence of improved Schirmer scores decreased symptoms and corneal and conjunctival staining at 6 mo Ocular comfort lasted for 3 hours following neurostimulationo Secondary effect intranasal application

promotes goblet cell mucin secretion which stabilizes the tear film1

Truetearcom

1Gumus K Schuetzle KL Pflugfelder SC Randomized controlled crossover trial comparing the impact of sham or intranasal tear neurostimulation on 654 GD Novack et al The Ocular Surface xxx (2017) 635e655 conjunctival goblet cell degranulation Am J Ophthalmol 2017177159e68

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Pharmaceutical to stimulate nerves

bullNasal Spray OC-01

bullOyster Point Pharma

bullStimulate natural tears

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Amniotic cytokine extract(Ocular Science)bullACE is a novel drop marketed as Genesis bullContains various cytokines growth factor

and anti-inflammatory moleculesbull Effective in a small pilot study

Amniotic Cytokine Extract Promising in Patients with Dry Ey Disease MDLinx

httpswwwmdlinxcomophthalmologyarticle1280 1113088 Accessed Jan 27 2018

Amniotic Cytokine Extract Promising in Patients with Dry Ey Disease MDLinx

httpswwwmdlinxcomophthalmologyarticle1280 1113088 Accessed Jan 27 2

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Recombinant human nerve growth factor (OxervateTM eye drops Dompeacute)

bull FDA Approval Aug 2018o First approved drug for Neurotropic keratitis (NK) ndashdegenerative disease with loss of corneal sensation o Topical eye drop o Clinical evidence of complete corneal healing in 70 of patients treated with Oxervate after 8 weeks1

1Bonini S et al Phase II Randomized Double-Masked Vehicle-Controlled Trial of Recombinant Human Nerve Growth Factor for Neurotrophic Keratitis Ophthalmology 125 1332ndash1343 (2018)

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Perfluorohexyloctane (NovaTears Novaliq)

bull Main effect prevent evaporative DED by increasing tear film and lipid layer thickness

bull Approved in Europe Australia and New Zealandbull Clinical evidence of increased tear production and tear film

stability as well as significant decrease in OSDI scores and in corneal staining1

1Steven P et al Semifluorinated Alkane Eye Drops for Treatment of Dry Eye Disease ndash A Prospective Multicenter Noninterventional Study J Ocul Pharmacol Ther 2015 Oct 1 31(8) 498-503

Corneal Epithelium Healing

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CrossThiolated Carboxymethyl Hyaluronic Acid Liquid-Gel

(Ocular Bandage Gel EyeGate Pharma)

bull Main effects accelerate corneal healing and reduce corneal stainingo Indicated for defects due to photorefcrative keratectomy (PRK)o Indicated for Punctate epitheliopathies (PE) associated with

dry eyebull Treatment in development July 2018 approval to conduct two

pilot studies using OBG for PE and PRKbull A first-in-human pilot study (n=39) showed accelerated corneal

reepithelialization through slit lamp examination at day 1 after PRK Further studies needed1

1Durrie Daniel S et al Ability of a new crosslinked polymer ocular bandage gel to accelerate reepithelialization after photorefractive keratectomy Journal of Cataract amp Refractive Surgery 443 (2018) 369-375

2018

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Biologic MoleculesDry Eye Assessment

bull Proteoglycan-4 (Lubricin)oRecently discovered on the ocular surface in the meibomian glands2

oFunctions to prevent friction at the cornea-lid interface and has anti-inflammatory propertiesoCommercial lubricin-based lubricants remain scarceoEvidence from clinical studies with recombinant human lubricin suggest

significant improvement in signs and symptoms of DED through TBUT corneal staining and eyelid and conjunctival redness3

1De Paiva CS Chotikavanich S Pangelinan SB Pitcher 3rd JD Fang B Zheng X et al IL-17 disrupts corneal barrier following desiccating stress Mucosal Immunol 20092(3)243ndash2532Iqbal SM Leonard C Regmi SC De Rantere D Tailor P Ren G et al LubricinProteoglycan 4 binds to and regulates the activity of Toll-Like Receptors In Vitro Sci Rep20166189103Lambiase A Sullivan BD Schmidt TA Sullivan DA Jay GD Truitt ER et al A Two-Week Randomized Double-masked Study to Evaluate Safety and Efficacy of Lubricin

(150 mugmL) Eye Drops Versus Sodium Hyaluronate (HA) 018 Eye Drops (Vismed(R)) in Patients with Moderate Dry Eye Disease Ocul Surf 20171577ndash87

2018

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Why Ocular Biomarkers

Surrogate Endpoints- None accepted by the FDA or Europe to date Validation needed- clear clinical relevance

Enrichment of Study Population Still regulatory hurdles

Support mechanism of action of treatment Topical ciclosporin in Europe for Dry eyes (Europe2015 Ikervis)1

SEGMENT THE DRY EYE POPULATION- TREAT MORE SPECIFICALLY-PERSONALIZE TREATMENT

1 Ikervis SmPC June 2015 available at httpswwwmedicinesorgukemcmedicine30584

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bull Currently approved in Japan and South Korea1

bull Main Effect Increase tear fluid and mucin secretion on the ocular surface through interaction with P2Y2 receptors in the conjunctiva

bull Evidence from clinical trials suggest diquafosol improves corneal staining more effectively than a comparable sodium hyaluronate solution2

Diquafosol Tetrasodium(3 Ophthalmic Solution)

1Koh Shizuka Clinical utility of 3 diquafosol ophthalmic solution in the treatment of dry eyes Clinical Ophthalmology (Auckland NZ) 9 (2015) 8652Takamura Etsuko et al A randomised double-masked comparison study of diquafosol versus sodium hyaluronate ophthalmic solutions in dry eye patients British Journal of Ophthalmology 9610 (2012) 1310-1315

Pubmedcom

Santencom

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Rebapimide

(2 Ophthalmic Solution)

bull Currently approved in Japanbull Main Effect stimulates mucin secretagogue activity in

cornea and conjunctivabull Clinical evidence suggests

o Statistically significant Improvement in corneal and conjunctival staining as well as in quality of life as well as in tear break-up time12

o Potential role in suppressing the expression of inflammatory proteins (Polyl)3

1 Kinoshita Shigeru et al Rebamipide (OPC-12759) in the treatment of dry eye a randomized double-masked multicenter placebo-controlled phase II study Ophthalmology11912 (2012) 2471-24782 Kashima Tomoyuki et al Rebamipide ophthalmic suspension for the treatment of dry eye syndrome a critical appraisal Clinical ophthalmology (Auckland NZ) 8 (2014) 10033Ueta Mayumi et al Rebamipide suppresses PolyI C-stimulated cytokine production in human conjunctival epithelial cells Journal of Ocular Pharmacology and Therapeutics 297 (2013) 688-693

2018

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TrueTearreg Allerganbull FDA Clearancebull Main effect intranasal applicator sends

electrical currents to nerves that stimulate tear production

bull Evidence of improved Schirmer scores decreased symptoms and corneal and conjunctival staining at 6 mo Ocular comfort lasted for 3 hours following neurostimulationo Secondary effect intranasal application

promotes goblet cell mucin secretion which stabilizes the tear film1

Truetearcom

1Gumus K Schuetzle KL Pflugfelder SC Randomized controlled crossover trial comparing the impact of sham or intranasal tear neurostimulation on 654 GD Novack et al The Ocular Surface xxx (2017) 635e655 conjunctival goblet cell degranulation Am J Ophthalmol 2017177159e68

2018

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Pharmaceutical to stimulate nerves

bullNasal Spray OC-01

bullOyster Point Pharma

bullStimulate natural tears

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Amniotic cytokine extract(Ocular Science)bullACE is a novel drop marketed as Genesis bullContains various cytokines growth factor

and anti-inflammatory moleculesbull Effective in a small pilot study

Amniotic Cytokine Extract Promising in Patients with Dry Ey Disease MDLinx

httpswwwmdlinxcomophthalmologyarticle1280 1113088 Accessed Jan 27 2018

Amniotic Cytokine Extract Promising in Patients with Dry Ey Disease MDLinx

httpswwwmdlinxcomophthalmologyarticle1280 1113088 Accessed Jan 27 2

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Recombinant human nerve growth factor (OxervateTM eye drops Dompeacute)

bull FDA Approval Aug 2018o First approved drug for Neurotropic keratitis (NK) ndashdegenerative disease with loss of corneal sensation o Topical eye drop o Clinical evidence of complete corneal healing in 70 of patients treated with Oxervate after 8 weeks1

1Bonini S et al Phase II Randomized Double-Masked Vehicle-Controlled Trial of Recombinant Human Nerve Growth Factor for Neurotrophic Keratitis Ophthalmology 125 1332ndash1343 (2018)

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Perfluorohexyloctane (NovaTears Novaliq)

bull Main effect prevent evaporative DED by increasing tear film and lipid layer thickness

bull Approved in Europe Australia and New Zealandbull Clinical evidence of increased tear production and tear film

stability as well as significant decrease in OSDI scores and in corneal staining1

1Steven P et al Semifluorinated Alkane Eye Drops for Treatment of Dry Eye Disease ndash A Prospective Multicenter Noninterventional Study J Ocul Pharmacol Ther 2015 Oct 1 31(8) 498-503

Corneal Epithelium Healing

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CrossThiolated Carboxymethyl Hyaluronic Acid Liquid-Gel

(Ocular Bandage Gel EyeGate Pharma)

bull Main effects accelerate corneal healing and reduce corneal stainingo Indicated for defects due to photorefcrative keratectomy (PRK)o Indicated for Punctate epitheliopathies (PE) associated with

dry eyebull Treatment in development July 2018 approval to conduct two

pilot studies using OBG for PE and PRKbull A first-in-human pilot study (n=39) showed accelerated corneal

reepithelialization through slit lamp examination at day 1 after PRK Further studies needed1

1Durrie Daniel S et al Ability of a new crosslinked polymer ocular bandage gel to accelerate reepithelialization after photorefractive keratectomy Journal of Cataract amp Refractive Surgery 443 (2018) 369-375

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Biologic MoleculesDry Eye Assessment

bull Proteoglycan-4 (Lubricin)oRecently discovered on the ocular surface in the meibomian glands2

oFunctions to prevent friction at the cornea-lid interface and has anti-inflammatory propertiesoCommercial lubricin-based lubricants remain scarceoEvidence from clinical studies with recombinant human lubricin suggest

significant improvement in signs and symptoms of DED through TBUT corneal staining and eyelid and conjunctival redness3

1De Paiva CS Chotikavanich S Pangelinan SB Pitcher 3rd JD Fang B Zheng X et al IL-17 disrupts corneal barrier following desiccating stress Mucosal Immunol 20092(3)243ndash2532Iqbal SM Leonard C Regmi SC De Rantere D Tailor P Ren G et al LubricinProteoglycan 4 binds to and regulates the activity of Toll-Like Receptors In Vitro Sci Rep20166189103Lambiase A Sullivan BD Schmidt TA Sullivan DA Jay GD Truitt ER et al A Two-Week Randomized Double-masked Study to Evaluate Safety and Efficacy of Lubricin

(150 mugmL) Eye Drops Versus Sodium Hyaluronate (HA) 018 Eye Drops (Vismed(R)) in Patients with Moderate Dry Eye Disease Ocul Surf 20171577ndash87

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Why Ocular Biomarkers

Surrogate Endpoints- None accepted by the FDA or Europe to date Validation needed- clear clinical relevance

Enrichment of Study Population Still regulatory hurdles

Support mechanism of action of treatment Topical ciclosporin in Europe for Dry eyes (Europe2015 Ikervis)1

SEGMENT THE DRY EYE POPULATION- TREAT MORE SPECIFICALLY-PERSONALIZE TREATMENT

1 Ikervis SmPC June 2015 available at httpswwwmedicinesorgukemcmedicine30584

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Rebapimide

(2 Ophthalmic Solution)

bull Currently approved in Japanbull Main Effect stimulates mucin secretagogue activity in

cornea and conjunctivabull Clinical evidence suggests

o Statistically significant Improvement in corneal and conjunctival staining as well as in quality of life as well as in tear break-up time12

o Potential role in suppressing the expression of inflammatory proteins (Polyl)3

1 Kinoshita Shigeru et al Rebamipide (OPC-12759) in the treatment of dry eye a randomized double-masked multicenter placebo-controlled phase II study Ophthalmology11912 (2012) 2471-24782 Kashima Tomoyuki et al Rebamipide ophthalmic suspension for the treatment of dry eye syndrome a critical appraisal Clinical ophthalmology (Auckland NZ) 8 (2014) 10033Ueta Mayumi et al Rebamipide suppresses PolyI C-stimulated cytokine production in human conjunctival epithelial cells Journal of Ocular Pharmacology and Therapeutics 297 (2013) 688-693

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TrueTearreg Allerganbull FDA Clearancebull Main effect intranasal applicator sends

electrical currents to nerves that stimulate tear production

bull Evidence of improved Schirmer scores decreased symptoms and corneal and conjunctival staining at 6 mo Ocular comfort lasted for 3 hours following neurostimulationo Secondary effect intranasal application

promotes goblet cell mucin secretion which stabilizes the tear film1

Truetearcom

1Gumus K Schuetzle KL Pflugfelder SC Randomized controlled crossover trial comparing the impact of sham or intranasal tear neurostimulation on 654 GD Novack et al The Ocular Surface xxx (2017) 635e655 conjunctival goblet cell degranulation Am J Ophthalmol 2017177159e68

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Pharmaceutical to stimulate nerves

bullNasal Spray OC-01

bullOyster Point Pharma

bullStimulate natural tears

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Amniotic cytokine extract(Ocular Science)bullACE is a novel drop marketed as Genesis bullContains various cytokines growth factor

and anti-inflammatory moleculesbull Effective in a small pilot study

Amniotic Cytokine Extract Promising in Patients with Dry Ey Disease MDLinx

httpswwwmdlinxcomophthalmologyarticle1280 1113088 Accessed Jan 27 2018

Amniotic Cytokine Extract Promising in Patients with Dry Ey Disease MDLinx

httpswwwmdlinxcomophthalmologyarticle1280 1113088 Accessed Jan 27 2

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Recombinant human nerve growth factor (OxervateTM eye drops Dompeacute)

bull FDA Approval Aug 2018o First approved drug for Neurotropic keratitis (NK) ndashdegenerative disease with loss of corneal sensation o Topical eye drop o Clinical evidence of complete corneal healing in 70 of patients treated with Oxervate after 8 weeks1

1Bonini S et al Phase II Randomized Double-Masked Vehicle-Controlled Trial of Recombinant Human Nerve Growth Factor for Neurotrophic Keratitis Ophthalmology 125 1332ndash1343 (2018)

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Perfluorohexyloctane (NovaTears Novaliq)

bull Main effect prevent evaporative DED by increasing tear film and lipid layer thickness

bull Approved in Europe Australia and New Zealandbull Clinical evidence of increased tear production and tear film

stability as well as significant decrease in OSDI scores and in corneal staining1

1Steven P et al Semifluorinated Alkane Eye Drops for Treatment of Dry Eye Disease ndash A Prospective Multicenter Noninterventional Study J Ocul Pharmacol Ther 2015 Oct 1 31(8) 498-503

Corneal Epithelium Healing

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CrossThiolated Carboxymethyl Hyaluronic Acid Liquid-Gel

(Ocular Bandage Gel EyeGate Pharma)

bull Main effects accelerate corneal healing and reduce corneal stainingo Indicated for defects due to photorefcrative keratectomy (PRK)o Indicated for Punctate epitheliopathies (PE) associated with

dry eyebull Treatment in development July 2018 approval to conduct two

pilot studies using OBG for PE and PRKbull A first-in-human pilot study (n=39) showed accelerated corneal

reepithelialization through slit lamp examination at day 1 after PRK Further studies needed1

1Durrie Daniel S et al Ability of a new crosslinked polymer ocular bandage gel to accelerate reepithelialization after photorefractive keratectomy Journal of Cataract amp Refractive Surgery 443 (2018) 369-375

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Biologic MoleculesDry Eye Assessment

bull Proteoglycan-4 (Lubricin)oRecently discovered on the ocular surface in the meibomian glands2

oFunctions to prevent friction at the cornea-lid interface and has anti-inflammatory propertiesoCommercial lubricin-based lubricants remain scarceoEvidence from clinical studies with recombinant human lubricin suggest

significant improvement in signs and symptoms of DED through TBUT corneal staining and eyelid and conjunctival redness3

1De Paiva CS Chotikavanich S Pangelinan SB Pitcher 3rd JD Fang B Zheng X et al IL-17 disrupts corneal barrier following desiccating stress Mucosal Immunol 20092(3)243ndash2532Iqbal SM Leonard C Regmi SC De Rantere D Tailor P Ren G et al LubricinProteoglycan 4 binds to and regulates the activity of Toll-Like Receptors In Vitro Sci Rep20166189103Lambiase A Sullivan BD Schmidt TA Sullivan DA Jay GD Truitt ER et al A Two-Week Randomized Double-masked Study to Evaluate Safety and Efficacy of Lubricin

(150 mugmL) Eye Drops Versus Sodium Hyaluronate (HA) 018 Eye Drops (Vismed(R)) in Patients with Moderate Dry Eye Disease Ocul Surf 20171577ndash87

2018

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Why Ocular Biomarkers

Surrogate Endpoints- None accepted by the FDA or Europe to date Validation needed- clear clinical relevance

Enrichment of Study Population Still regulatory hurdles

Support mechanism of action of treatment Topical ciclosporin in Europe for Dry eyes (Europe2015 Ikervis)1

SEGMENT THE DRY EYE POPULATION- TREAT MORE SPECIFICALLY-PERSONALIZE TREATMENT

1 Ikervis SmPC June 2015 available at httpswwwmedicinesorgukemcmedicine30584

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TrueTearreg Allerganbull FDA Clearancebull Main effect intranasal applicator sends

electrical currents to nerves that stimulate tear production

bull Evidence of improved Schirmer scores decreased symptoms and corneal and conjunctival staining at 6 mo Ocular comfort lasted for 3 hours following neurostimulationo Secondary effect intranasal application

promotes goblet cell mucin secretion which stabilizes the tear film1

Truetearcom

1Gumus K Schuetzle KL Pflugfelder SC Randomized controlled crossover trial comparing the impact of sham or intranasal tear neurostimulation on 654 GD Novack et al The Ocular Surface xxx (2017) 635e655 conjunctival goblet cell degranulation Am J Ophthalmol 2017177159e68

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Pharmaceutical to stimulate nerves

bullNasal Spray OC-01

bullOyster Point Pharma

bullStimulate natural tears

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Amniotic cytokine extract(Ocular Science)bullACE is a novel drop marketed as Genesis bullContains various cytokines growth factor

and anti-inflammatory moleculesbull Effective in a small pilot study

Amniotic Cytokine Extract Promising in Patients with Dry Ey Disease MDLinx

httpswwwmdlinxcomophthalmologyarticle1280 1113088 Accessed Jan 27 2018

Amniotic Cytokine Extract Promising in Patients with Dry Ey Disease MDLinx

httpswwwmdlinxcomophthalmologyarticle1280 1113088 Accessed Jan 27 2

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Recombinant human nerve growth factor (OxervateTM eye drops Dompeacute)

bull FDA Approval Aug 2018o First approved drug for Neurotropic keratitis (NK) ndashdegenerative disease with loss of corneal sensation o Topical eye drop o Clinical evidence of complete corneal healing in 70 of patients treated with Oxervate after 8 weeks1

1Bonini S et al Phase II Randomized Double-Masked Vehicle-Controlled Trial of Recombinant Human Nerve Growth Factor for Neurotrophic Keratitis Ophthalmology 125 1332ndash1343 (2018)

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Perfluorohexyloctane (NovaTears Novaliq)

bull Main effect prevent evaporative DED by increasing tear film and lipid layer thickness

bull Approved in Europe Australia and New Zealandbull Clinical evidence of increased tear production and tear film

stability as well as significant decrease in OSDI scores and in corneal staining1

1Steven P et al Semifluorinated Alkane Eye Drops for Treatment of Dry Eye Disease ndash A Prospective Multicenter Noninterventional Study J Ocul Pharmacol Ther 2015 Oct 1 31(8) 498-503

Corneal Epithelium Healing

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CrossThiolated Carboxymethyl Hyaluronic Acid Liquid-Gel

(Ocular Bandage Gel EyeGate Pharma)

bull Main effects accelerate corneal healing and reduce corneal stainingo Indicated for defects due to photorefcrative keratectomy (PRK)o Indicated for Punctate epitheliopathies (PE) associated with

dry eyebull Treatment in development July 2018 approval to conduct two

pilot studies using OBG for PE and PRKbull A first-in-human pilot study (n=39) showed accelerated corneal

reepithelialization through slit lamp examination at day 1 after PRK Further studies needed1

1Durrie Daniel S et al Ability of a new crosslinked polymer ocular bandage gel to accelerate reepithelialization after photorefractive keratectomy Journal of Cataract amp Refractive Surgery 443 (2018) 369-375

2018

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Biologic MoleculesDry Eye Assessment

bull Proteoglycan-4 (Lubricin)oRecently discovered on the ocular surface in the meibomian glands2

oFunctions to prevent friction at the cornea-lid interface and has anti-inflammatory propertiesoCommercial lubricin-based lubricants remain scarceoEvidence from clinical studies with recombinant human lubricin suggest

significant improvement in signs and symptoms of DED through TBUT corneal staining and eyelid and conjunctival redness3

1De Paiva CS Chotikavanich S Pangelinan SB Pitcher 3rd JD Fang B Zheng X et al IL-17 disrupts corneal barrier following desiccating stress Mucosal Immunol 20092(3)243ndash2532Iqbal SM Leonard C Regmi SC De Rantere D Tailor P Ren G et al LubricinProteoglycan 4 binds to and regulates the activity of Toll-Like Receptors In Vitro Sci Rep20166189103Lambiase A Sullivan BD Schmidt TA Sullivan DA Jay GD Truitt ER et al A Two-Week Randomized Double-masked Study to Evaluate Safety and Efficacy of Lubricin

(150 mugmL) Eye Drops Versus Sodium Hyaluronate (HA) 018 Eye Drops (Vismed(R)) in Patients with Moderate Dry Eye Disease Ocul Surf 20171577ndash87

2018

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Why Ocular Biomarkers

Surrogate Endpoints- None accepted by the FDA or Europe to date Validation needed- clear clinical relevance

Enrichment of Study Population Still regulatory hurdles

Support mechanism of action of treatment Topical ciclosporin in Europe for Dry eyes (Europe2015 Ikervis)1

SEGMENT THE DRY EYE POPULATION- TREAT MORE SPECIFICALLY-PERSONALIZE TREATMENT

1 Ikervis SmPC June 2015 available at httpswwwmedicinesorgukemcmedicine30584

2018

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Pharmaceutical to stimulate nerves

bullNasal Spray OC-01

bullOyster Point Pharma

bullStimulate natural tears

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Amniotic cytokine extract(Ocular Science)bullACE is a novel drop marketed as Genesis bullContains various cytokines growth factor

and anti-inflammatory moleculesbull Effective in a small pilot study

Amniotic Cytokine Extract Promising in Patients with Dry Ey Disease MDLinx

httpswwwmdlinxcomophthalmologyarticle1280 1113088 Accessed Jan 27 2018

Amniotic Cytokine Extract Promising in Patients with Dry Ey Disease MDLinx

httpswwwmdlinxcomophthalmologyarticle1280 1113088 Accessed Jan 27 2

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Recombinant human nerve growth factor (OxervateTM eye drops Dompeacute)

bull FDA Approval Aug 2018o First approved drug for Neurotropic keratitis (NK) ndashdegenerative disease with loss of corneal sensation o Topical eye drop o Clinical evidence of complete corneal healing in 70 of patients treated with Oxervate after 8 weeks1

1Bonini S et al Phase II Randomized Double-Masked Vehicle-Controlled Trial of Recombinant Human Nerve Growth Factor for Neurotrophic Keratitis Ophthalmology 125 1332ndash1343 (2018)

2018

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Perfluorohexyloctane (NovaTears Novaliq)

bull Main effect prevent evaporative DED by increasing tear film and lipid layer thickness

bull Approved in Europe Australia and New Zealandbull Clinical evidence of increased tear production and tear film

stability as well as significant decrease in OSDI scores and in corneal staining1

1Steven P et al Semifluorinated Alkane Eye Drops for Treatment of Dry Eye Disease ndash A Prospective Multicenter Noninterventional Study J Ocul Pharmacol Ther 2015 Oct 1 31(8) 498-503

Corneal Epithelium Healing

2018

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CrossThiolated Carboxymethyl Hyaluronic Acid Liquid-Gel

(Ocular Bandage Gel EyeGate Pharma)

bull Main effects accelerate corneal healing and reduce corneal stainingo Indicated for defects due to photorefcrative keratectomy (PRK)o Indicated for Punctate epitheliopathies (PE) associated with

dry eyebull Treatment in development July 2018 approval to conduct two

pilot studies using OBG for PE and PRKbull A first-in-human pilot study (n=39) showed accelerated corneal

reepithelialization through slit lamp examination at day 1 after PRK Further studies needed1

1Durrie Daniel S et al Ability of a new crosslinked polymer ocular bandage gel to accelerate reepithelialization after photorefractive keratectomy Journal of Cataract amp Refractive Surgery 443 (2018) 369-375

2018

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Biologic MoleculesDry Eye Assessment

bull Proteoglycan-4 (Lubricin)oRecently discovered on the ocular surface in the meibomian glands2

oFunctions to prevent friction at the cornea-lid interface and has anti-inflammatory propertiesoCommercial lubricin-based lubricants remain scarceoEvidence from clinical studies with recombinant human lubricin suggest

significant improvement in signs and symptoms of DED through TBUT corneal staining and eyelid and conjunctival redness3

1De Paiva CS Chotikavanich S Pangelinan SB Pitcher 3rd JD Fang B Zheng X et al IL-17 disrupts corneal barrier following desiccating stress Mucosal Immunol 20092(3)243ndash2532Iqbal SM Leonard C Regmi SC De Rantere D Tailor P Ren G et al LubricinProteoglycan 4 binds to and regulates the activity of Toll-Like Receptors In Vitro Sci Rep20166189103Lambiase A Sullivan BD Schmidt TA Sullivan DA Jay GD Truitt ER et al A Two-Week Randomized Double-masked Study to Evaluate Safety and Efficacy of Lubricin

(150 mugmL) Eye Drops Versus Sodium Hyaluronate (HA) 018 Eye Drops (Vismed(R)) in Patients with Moderate Dry Eye Disease Ocul Surf 20171577ndash87

2018

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Why Ocular Biomarkers

Surrogate Endpoints- None accepted by the FDA or Europe to date Validation needed- clear clinical relevance

Enrichment of Study Population Still regulatory hurdles

Support mechanism of action of treatment Topical ciclosporin in Europe for Dry eyes (Europe2015 Ikervis)1

SEGMENT THE DRY EYE POPULATION- TREAT MORE SPECIFICALLY-PERSONALIZE TREATMENT

1 Ikervis SmPC June 2015 available at httpswwwmedicinesorgukemcmedicine30584

2018

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Amniotic cytokine extract(Ocular Science)bullACE is a novel drop marketed as Genesis bullContains various cytokines growth factor

and anti-inflammatory moleculesbull Effective in a small pilot study

Amniotic Cytokine Extract Promising in Patients with Dry Ey Disease MDLinx

httpswwwmdlinxcomophthalmologyarticle1280 1113088 Accessed Jan 27 2018

Amniotic Cytokine Extract Promising in Patients with Dry Ey Disease MDLinx

httpswwwmdlinxcomophthalmologyarticle1280 1113088 Accessed Jan 27 2

2018

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Recombinant human nerve growth factor (OxervateTM eye drops Dompeacute)

bull FDA Approval Aug 2018o First approved drug for Neurotropic keratitis (NK) ndashdegenerative disease with loss of corneal sensation o Topical eye drop o Clinical evidence of complete corneal healing in 70 of patients treated with Oxervate after 8 weeks1

1Bonini S et al Phase II Randomized Double-Masked Vehicle-Controlled Trial of Recombinant Human Nerve Growth Factor for Neurotrophic Keratitis Ophthalmology 125 1332ndash1343 (2018)

2018

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Perfluorohexyloctane (NovaTears Novaliq)

bull Main effect prevent evaporative DED by increasing tear film and lipid layer thickness

bull Approved in Europe Australia and New Zealandbull Clinical evidence of increased tear production and tear film

stability as well as significant decrease in OSDI scores and in corneal staining1

1Steven P et al Semifluorinated Alkane Eye Drops for Treatment of Dry Eye Disease ndash A Prospective Multicenter Noninterventional Study J Ocul Pharmacol Ther 2015 Oct 1 31(8) 498-503

Corneal Epithelium Healing

2018

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CrossThiolated Carboxymethyl Hyaluronic Acid Liquid-Gel

(Ocular Bandage Gel EyeGate Pharma)

bull Main effects accelerate corneal healing and reduce corneal stainingo Indicated for defects due to photorefcrative keratectomy (PRK)o Indicated for Punctate epitheliopathies (PE) associated with

dry eyebull Treatment in development July 2018 approval to conduct two

pilot studies using OBG for PE and PRKbull A first-in-human pilot study (n=39) showed accelerated corneal

reepithelialization through slit lamp examination at day 1 after PRK Further studies needed1

1Durrie Daniel S et al Ability of a new crosslinked polymer ocular bandage gel to accelerate reepithelialization after photorefractive keratectomy Journal of Cataract amp Refractive Surgery 443 (2018) 369-375

2018

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Biologic MoleculesDry Eye Assessment

bull Proteoglycan-4 (Lubricin)oRecently discovered on the ocular surface in the meibomian glands2

oFunctions to prevent friction at the cornea-lid interface and has anti-inflammatory propertiesoCommercial lubricin-based lubricants remain scarceoEvidence from clinical studies with recombinant human lubricin suggest

significant improvement in signs and symptoms of DED through TBUT corneal staining and eyelid and conjunctival redness3

1De Paiva CS Chotikavanich S Pangelinan SB Pitcher 3rd JD Fang B Zheng X et al IL-17 disrupts corneal barrier following desiccating stress Mucosal Immunol 20092(3)243ndash2532Iqbal SM Leonard C Regmi SC De Rantere D Tailor P Ren G et al LubricinProteoglycan 4 binds to and regulates the activity of Toll-Like Receptors In Vitro Sci Rep20166189103Lambiase A Sullivan BD Schmidt TA Sullivan DA Jay GD Truitt ER et al A Two-Week Randomized Double-masked Study to Evaluate Safety and Efficacy of Lubricin

(150 mugmL) Eye Drops Versus Sodium Hyaluronate (HA) 018 Eye Drops (Vismed(R)) in Patients with Moderate Dry Eye Disease Ocul Surf 20171577ndash87

2018

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ven i

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ohibi

ted]

Why Ocular Biomarkers

Surrogate Endpoints- None accepted by the FDA or Europe to date Validation needed- clear clinical relevance

Enrichment of Study Population Still regulatory hurdles

Support mechanism of action of treatment Topical ciclosporin in Europe for Dry eyes (Europe2015 Ikervis)1

SEGMENT THE DRY EYE POPULATION- TREAT MORE SPECIFICALLY-PERSONALIZE TREATMENT

1 Ikervis SmPC June 2015 available at httpswwwmedicinesorgukemcmedicine30584

2018

copy 48

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Recombinant human nerve growth factor (OxervateTM eye drops Dompeacute)

bull FDA Approval Aug 2018o First approved drug for Neurotropic keratitis (NK) ndashdegenerative disease with loss of corneal sensation o Topical eye drop o Clinical evidence of complete corneal healing in 70 of patients treated with Oxervate after 8 weeks1

1Bonini S et al Phase II Randomized Double-Masked Vehicle-Controlled Trial of Recombinant Human Nerve Growth Factor for Neurotrophic Keratitis Ophthalmology 125 1332ndash1343 (2018)

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Perfluorohexyloctane (NovaTears Novaliq)

bull Main effect prevent evaporative DED by increasing tear film and lipid layer thickness

bull Approved in Europe Australia and New Zealandbull Clinical evidence of increased tear production and tear film

stability as well as significant decrease in OSDI scores and in corneal staining1

1Steven P et al Semifluorinated Alkane Eye Drops for Treatment of Dry Eye Disease ndash A Prospective Multicenter Noninterventional Study J Ocul Pharmacol Ther 2015 Oct 1 31(8) 498-503

Corneal Epithelium Healing

2018

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CrossThiolated Carboxymethyl Hyaluronic Acid Liquid-Gel

(Ocular Bandage Gel EyeGate Pharma)

bull Main effects accelerate corneal healing and reduce corneal stainingo Indicated for defects due to photorefcrative keratectomy (PRK)o Indicated for Punctate epitheliopathies (PE) associated with

dry eyebull Treatment in development July 2018 approval to conduct two

pilot studies using OBG for PE and PRKbull A first-in-human pilot study (n=39) showed accelerated corneal

reepithelialization through slit lamp examination at day 1 after PRK Further studies needed1

1Durrie Daniel S et al Ability of a new crosslinked polymer ocular bandage gel to accelerate reepithelialization after photorefractive keratectomy Journal of Cataract amp Refractive Surgery 443 (2018) 369-375

2018

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Biologic MoleculesDry Eye Assessment

bull Proteoglycan-4 (Lubricin)oRecently discovered on the ocular surface in the meibomian glands2

oFunctions to prevent friction at the cornea-lid interface and has anti-inflammatory propertiesoCommercial lubricin-based lubricants remain scarceoEvidence from clinical studies with recombinant human lubricin suggest

significant improvement in signs and symptoms of DED through TBUT corneal staining and eyelid and conjunctival redness3

1De Paiva CS Chotikavanich S Pangelinan SB Pitcher 3rd JD Fang B Zheng X et al IL-17 disrupts corneal barrier following desiccating stress Mucosal Immunol 20092(3)243ndash2532Iqbal SM Leonard C Regmi SC De Rantere D Tailor P Ren G et al LubricinProteoglycan 4 binds to and regulates the activity of Toll-Like Receptors In Vitro Sci Rep20166189103Lambiase A Sullivan BD Schmidt TA Sullivan DA Jay GD Truitt ER et al A Two-Week Randomized Double-masked Study to Evaluate Safety and Efficacy of Lubricin

(150 mugmL) Eye Drops Versus Sodium Hyaluronate (HA) 018 Eye Drops (Vismed(R)) in Patients with Moderate Dry Eye Disease Ocul Surf 20171577ndash87

2018

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Why Ocular Biomarkers

Surrogate Endpoints- None accepted by the FDA or Europe to date Validation needed- clear clinical relevance

Enrichment of Study Population Still regulatory hurdles

Support mechanism of action of treatment Topical ciclosporin in Europe for Dry eyes (Europe2015 Ikervis)1

SEGMENT THE DRY EYE POPULATION- TREAT MORE SPECIFICALLY-PERSONALIZE TREATMENT

1 Ikervis SmPC June 2015 available at httpswwwmedicinesorgukemcmedicine30584

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ted]

Perfluorohexyloctane (NovaTears Novaliq)

bull Main effect prevent evaporative DED by increasing tear film and lipid layer thickness

bull Approved in Europe Australia and New Zealandbull Clinical evidence of increased tear production and tear film

stability as well as significant decrease in OSDI scores and in corneal staining1

1Steven P et al Semifluorinated Alkane Eye Drops for Treatment of Dry Eye Disease ndash A Prospective Multicenter Noninterventional Study J Ocul Pharmacol Ther 2015 Oct 1 31(8) 498-503

Corneal Epithelium Healing

2018

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ven i

n par

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ohibi

ted]

CrossThiolated Carboxymethyl Hyaluronic Acid Liquid-Gel

(Ocular Bandage Gel EyeGate Pharma)

bull Main effects accelerate corneal healing and reduce corneal stainingo Indicated for defects due to photorefcrative keratectomy (PRK)o Indicated for Punctate epitheliopathies (PE) associated with

dry eyebull Treatment in development July 2018 approval to conduct two

pilot studies using OBG for PE and PRKbull A first-in-human pilot study (n=39) showed accelerated corneal

reepithelialization through slit lamp examination at day 1 after PRK Further studies needed1

1Durrie Daniel S et al Ability of a new crosslinked polymer ocular bandage gel to accelerate reepithelialization after photorefractive keratectomy Journal of Cataract amp Refractive Surgery 443 (2018) 369-375

2018

copy 48

th Eur

opea

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Biologic MoleculesDry Eye Assessment

bull Proteoglycan-4 (Lubricin)oRecently discovered on the ocular surface in the meibomian glands2

oFunctions to prevent friction at the cornea-lid interface and has anti-inflammatory propertiesoCommercial lubricin-based lubricants remain scarceoEvidence from clinical studies with recombinant human lubricin suggest

significant improvement in signs and symptoms of DED through TBUT corneal staining and eyelid and conjunctival redness3

1De Paiva CS Chotikavanich S Pangelinan SB Pitcher 3rd JD Fang B Zheng X et al IL-17 disrupts corneal barrier following desiccating stress Mucosal Immunol 20092(3)243ndash2532Iqbal SM Leonard C Regmi SC De Rantere D Tailor P Ren G et al LubricinProteoglycan 4 binds to and regulates the activity of Toll-Like Receptors In Vitro Sci Rep20166189103Lambiase A Sullivan BD Schmidt TA Sullivan DA Jay GD Truitt ER et al A Two-Week Randomized Double-masked Study to Evaluate Safety and Efficacy of Lubricin

(150 mugmL) Eye Drops Versus Sodium Hyaluronate (HA) 018 Eye Drops (Vismed(R)) in Patients with Moderate Dry Eye Disease Ocul Surf 20171577ndash87

2018

copy 48

th Eur

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2018

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2018

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2018

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2018

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2018

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2018

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2018

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2018

copy 48

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Why Ocular Biomarkers

Surrogate Endpoints- None accepted by the FDA or Europe to date Validation needed- clear clinical relevance

Enrichment of Study Population Still regulatory hurdles

Support mechanism of action of treatment Topical ciclosporin in Europe for Dry eyes (Europe2015 Ikervis)1

SEGMENT THE DRY EYE POPULATION- TREAT MORE SPECIFICALLY-PERSONALIZE TREATMENT

1 Ikervis SmPC June 2015 available at httpswwwmedicinesorgukemcmedicine30584

2018

copy 48

th Eur

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n Con

tact L

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phtha

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2018

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2018

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2018

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2018

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2018

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2018

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2018

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2018

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CrossThiolated Carboxymethyl Hyaluronic Acid Liquid-Gel

(Ocular Bandage Gel EyeGate Pharma)

bull Main effects accelerate corneal healing and reduce corneal stainingo Indicated for defects due to photorefcrative keratectomy (PRK)o Indicated for Punctate epitheliopathies (PE) associated with

dry eyebull Treatment in development July 2018 approval to conduct two

pilot studies using OBG for PE and PRKbull A first-in-human pilot study (n=39) showed accelerated corneal

reepithelialization through slit lamp examination at day 1 after PRK Further studies needed1

1Durrie Daniel S et al Ability of a new crosslinked polymer ocular bandage gel to accelerate reepithelialization after photorefractive keratectomy Journal of Cataract amp Refractive Surgery 443 (2018) 369-375

2018

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2018

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2018

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2018

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2018

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2018

copy 48

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2018

copy 48

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2018

copy 48

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2018

copy 48

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All r

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Any

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oduc

tion e

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ted]

Biologic MoleculesDry Eye Assessment

bull Proteoglycan-4 (Lubricin)oRecently discovered on the ocular surface in the meibomian glands2

oFunctions to prevent friction at the cornea-lid interface and has anti-inflammatory propertiesoCommercial lubricin-based lubricants remain scarceoEvidence from clinical studies with recombinant human lubricin suggest

significant improvement in signs and symptoms of DED through TBUT corneal staining and eyelid and conjunctival redness3

1De Paiva CS Chotikavanich S Pangelinan SB Pitcher 3rd JD Fang B Zheng X et al IL-17 disrupts corneal barrier following desiccating stress Mucosal Immunol 20092(3)243ndash2532Iqbal SM Leonard C Regmi SC De Rantere D Tailor P Ren G et al LubricinProteoglycan 4 binds to and regulates the activity of Toll-Like Receptors In Vitro Sci Rep20166189103Lambiase A Sullivan BD Schmidt TA Sullivan DA Jay GD Truitt ER et al A Two-Week Randomized Double-masked Study to Evaluate Safety and Efficacy of Lubricin

(150 mugmL) Eye Drops Versus Sodium Hyaluronate (HA) 018 Eye Drops (Vismed(R)) in Patients with Moderate Dry Eye Disease Ocul Surf 20171577ndash87

2018

copy 48

th Eur

opea

n Con

tact L

ens S

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y Of O

phtha

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gists

All r

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rese

rved -

Any

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2018

copy 48

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Any

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2018

copy 48

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2018

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2018

copy 48

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2018

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2018

copy 48

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2018

copy 48

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2018

copy 48

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All r

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oduc

tion e

ven i

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t is pr

ohibi

ted]

Why Ocular Biomarkers

Surrogate Endpoints- None accepted by the FDA or Europe to date Validation needed- clear clinical relevance

Enrichment of Study Population Still regulatory hurdles

Support mechanism of action of treatment Topical ciclosporin in Europe for Dry eyes (Europe2015 Ikervis)1

SEGMENT THE DRY EYE POPULATION- TREAT MORE SPECIFICALLY-PERSONALIZE TREATMENT

1 Ikervis SmPC June 2015 available at httpswwwmedicinesorgukemcmedicine30584

2018

copy 48

th Eur

opea

n Con

tact L

ens S

ociet

y Of O

phtha

lmolo

gists

All r

ights

rese

rved -

Any

repr

oduc

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ohibi

ted

2018

copy 48

th Eur

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All r

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Any

repr

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2018

copy 48

th Eur

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2018

copy 48

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2018

copy 48

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2018

copy 48

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2018

copy 48

th Eur

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2018

copy 48

th Eur

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2018

copy 48

th Eur

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All r

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oduc

tion e

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ohibi

ted]

Biologic MoleculesDry Eye Assessment

bull Proteoglycan-4 (Lubricin)oRecently discovered on the ocular surface in the meibomian glands2

oFunctions to prevent friction at the cornea-lid interface and has anti-inflammatory propertiesoCommercial lubricin-based lubricants remain scarceoEvidence from clinical studies with recombinant human lubricin suggest

significant improvement in signs and symptoms of DED through TBUT corneal staining and eyelid and conjunctival redness3

1De Paiva CS Chotikavanich S Pangelinan SB Pitcher 3rd JD Fang B Zheng X et al IL-17 disrupts corneal barrier following desiccating stress Mucosal Immunol 20092(3)243ndash2532Iqbal SM Leonard C Regmi SC De Rantere D Tailor P Ren G et al LubricinProteoglycan 4 binds to and regulates the activity of Toll-Like Receptors In Vitro Sci Rep20166189103Lambiase A Sullivan BD Schmidt TA Sullivan DA Jay GD Truitt ER et al A Two-Week Randomized Double-masked Study to Evaluate Safety and Efficacy of Lubricin

(150 mugmL) Eye Drops Versus Sodium Hyaluronate (HA) 018 Eye Drops (Vismed(R)) in Patients with Moderate Dry Eye Disease Ocul Surf 20171577ndash87

2018

copy 48

th Eur

opea

n Con

tact L

ens S

ociet

y Of O

phtha

lmolo

gists

All r

ights

rese

rved -

Any

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2018

copy 48

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2018

copy 48

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2018

copy 48

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2018

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2018

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2018

copy 48

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2018

copy 48

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2018

copy 48

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All r

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oduc

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ohibi

ted]

Why Ocular Biomarkers

Surrogate Endpoints- None accepted by the FDA or Europe to date Validation needed- clear clinical relevance

Enrichment of Study Population Still regulatory hurdles

Support mechanism of action of treatment Topical ciclosporin in Europe for Dry eyes (Europe2015 Ikervis)1

SEGMENT THE DRY EYE POPULATION- TREAT MORE SPECIFICALLY-PERSONALIZE TREATMENT

1 Ikervis SmPC June 2015 available at httpswwwmedicinesorgukemcmedicine30584

2018

copy 48

th Eur

opea

n Con

tact L

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y Of O

phtha

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2018

copy 48

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2018

copy 48

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2018

copy 48

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2018

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2018

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2018

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2018

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2018

copy 48

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All r

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Any

repr

oduc

tion e

ven i

n par

t is pr

ohibi

ted]

Why Ocular Biomarkers

Surrogate Endpoints- None accepted by the FDA or Europe to date Validation needed- clear clinical relevance

Enrichment of Study Population Still regulatory hurdles

Support mechanism of action of treatment Topical ciclosporin in Europe for Dry eyes (Europe2015 Ikervis)1

SEGMENT THE DRY EYE POPULATION- TREAT MORE SPECIFICALLY-PERSONALIZE TREATMENT

1 Ikervis SmPC June 2015 available at httpswwwmedicinesorgukemcmedicine30584

2018

copy 48

th Eur

opea

n Con

tact L

ens S

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