ForSight Vision-5

© ForSight VISION5 2014 1

Ophthalmology Innovation Summit 16 October 2014


n  5th Company Launched by ForSight Labs

n  VC Syndicate with Significant Ophthalmic Experience

STRONG FOUNDATION

Who We Are: ForSight VISION5

CLINICAL RESULTS

n  70+ Patient Open-Label Efficacy Data

n  Excellent Patient Comfort & Retention

n  Phase 2 is Enrolled; Final Data in Q4:14

n  Goal of Non-Invasive 3 to 6 Month Therapy = First in Class

n  Lead Product in Phase 2

n  Robust Pipeline

INNOVATION & EXECUTION

MARKET NEED

n  Goal: Improve Ophthalmic Medication Adherence

n  Non-Invasive, Sustained Release Drug Delivery System


Initial Target Market

Novel Non-Invasive Insert System to Deliver Sustained Therapy to the Ocular Surface

Sources: 1Adapted from IMS data and Friedman et al. Invest Ophthalmol Vis Sci. 2007;48:5052– 5057. 2Adapted from: http://www.ncbi.nlm.nih.gov/pubmed/12888056 and http://www.ncbi.nlm.nih.gov/pubmed/19506195 3NPA, data from Q3: 2010 for Pataday, Patanol, Bepreve, Elestat, Optivar, and others as quoted by ISTA pharmaceuticals and Red Book data pricing for Pataday.

2MM Patients

GLAUCOMA

1

§ PGA has Demonstrated Efficacy § Long Duration (180 day target)

5MM Patients

DRY EYE

2 300k Patients

ALLERGY

3


VISION5 Target Market: Glaucoma / OHT Patients who are Non-Compliant or Unable to Take Drops

1NICE Guidelines: http://www.nice.org.uk/nicemedia/live/12145/43888/43888.pdf; Appendix F, p.246 2Calculated as follows: IMS data shows 14.25MM Rx’s in 2012 for PGAs in USA. Mean medication possession ratio = 0.64 (Friedman et al. (Invest Ophthalmol Vis Sci. 2007;48:5052–5057). ((14.25MM)/12 months)/0.64 Rx/Pt/Month= 1.9MM patients

3Nordstrom, et al. “Persistence and Adherence with Topical Glaucoma Therapy.” Am J Ophthalmol 2005;140:598-606. 4Hennessy AL, Katz J, Covert D, Kelly CA, Suan EP, Speicher MA, Sund NJ, Robin AL. A video study of drop instillation in both glaucoma and retina patients with visual impairment. Am J Ophthalmol. 2011 Dec;152(6):982-8

Highly-Effective Treatments Exist n  Prostaglandin Drops Reduce the Likelihood of

Progression by 34-42% / Year1

n  2 Million Patients in USA Use PGA as First Line Treatment2

n  PGAs Approved by FDA in 1990s; Excellent Safety Profile

n  Of Glaucoma Patients, ~60% Cannot Administer Drops Properly4

Yet <50% Use Them After One Year3


16% 14% 17% 26%

1 or More Difficulties,

56%

None, 44%

Returns with Uncontrolled

IOP

Requires a Caregiver to

Administer Eye Drops

Frequently Runs Out of Eye Drops before Insurance

Covers Refill

Forgets to Regularly

Administer Eye Drops

Difficulties with Drop

Administration

Glaucoma Patients Experience Difficulty Taking Drops

Source: Third party survey of 75 ophthalmologists, 2014. Data on file.

n  Non-Compliant Patients Present a Key Unmet Need and Sustained Release Addresses Treatment Burden

Q: “What Percentage of Your Patients…?”


Strong Market Demand for Product that Solves Compliance

Appear to be Non-Compliant

Appear to be Compliant

Similar Efficacy as Timolol 70% 46%

Similar Efficacy as Latanoprost 72% 57%

Q: “If this Product Reduced IOP Similar to (Timolol or Latanoprost), While Guaranteeing 100% Compliance, in What Percentage of Your Patients Would You Use It?”

AAO 2012—ForSight VISION5 Market Research (N = 101), conducted by an independent 3rd party

Conclusion: Simple, Effective Product would have Wide Market Adoption

Appear to be Non-Compliant

Similar Efficacy as Timolol 70%

Similar Efficacy as Latanoprost 72%


ForSight HeliosTM Insert and Compliant Dosing

IOP CONTROL n  Continuous Control of

Intraocular Pressure (IOP)

n  Highly Effective PGA, (Approved Eye Drop)

n  Addresses Compliance

n  Preservative Free

INTUITIVE & DURABLE n  Designed to Eliminate Daily

Drops

n  Reapplication During Existing, Established Visit Schedule for Patients

NON-INVASIVE n  Simple Application by Eye

Care Professional on Ocular Surface

n  Comfortable to Wear – 90-95% Patient Acceptance*

n  High Product Retention Rates

Source: *95% (37 of 39) of patients in Study 305 found Insert acceptably comfortable.


Insert Slowly Releases Medication for Months

n  Drug Release is Gradual, Controlled, and Predictable

n  PGA Diffuses through Polymer and Releases into Tear Film

n  PGA in Tear Film Diffuses through Cornea and Sclera to Effect IOP

Day 1: Drug close to surface is released; other drug diffuses closer to surface

Diffusion-Mediated Drug Release from Polymer:

Day 180: Drug-depleted zones of matrix are present

6 months


Phase 1 Dose-Finding Informed Phase 2 Dose Selection

Product Configuration Clinical Locales # of Subjects

Low Duration

ANZ 15

Mid-Duration ANZ/EU 43

High Duration (V501P) ANZ/EU US Phase II US Extension Study

31 (open-label) ~65 (High Duration Arm) 50+

Mid Duration Efficacy Data to be Presented on Monday at AAO

by Prof. Ivan Goldberg

(Poster PO390)

0 30 60 90 120 150 180

Elut

ion

Rate

(m

cg

/da

y)

Time (Days)

Low Duration Mid Duration High Duration


USA Patients find Product Comfortable

n  Insert was Tested in 39 Patients at 3 Clinical Sites for 2 Months in USA*

–  Insert Did Not Contain Drug –  Tested for Fitting and Comfort

n  Results: –  37 of 39 Patients (95%)

Completed Full Two-Month Study

*ForSight VISION5 Clinical Study 305

Completed 2 Month

Study 95%, (n = 37)

Withdrew Early

(Discomfort) 5%, (n = 2)

Study Provided Confidence to Start Phase 2 Study in USA


0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Washout Month 1 Month 2 Month 3 Month 4 Month 5 Month 6

% S

ubje

cts

Study Month

% of Patients Retaining Inserts in Month

Insert Retention in Phase 2 Study is Very High

94% in washout month

(learning period)

Data as of 19 August 2014; data pooled from both arms of study. N=130 Subjects Randomized. Study in Follow-Up.

98% per month observed on

treatment


Phase 2 Study Design: Randomized Controlled Trial

n  Primary Endpoint through 3 months; Patients will be followed through 6 months (secondary endpoints) on same inserts

n  Final Data Expected Q4:14


ForSight VISION5 is Actively Developing Products for Three Major Indications

n  Lead Product (PGA) Expected to Start Phase 3 Studies in 2015

n  Programs also Active in Dry Eye and Allergy – Stay Tuned!

2MM Patients

GLAUCOMA

5MM Patients

DRY EYE

300k Patients

ALLERGY


Team of Leaders and Experts

ForSight VISION5 Team

John Maroney Chief Executive Officer; Delphi Ventures, EndoTex, Boston Scientific; CVIS, Abbott Labs, Oximetrix

Cary Reich, Ph.D. Chief Technology Officer; Inamed, Calhoun Vision and Chiron Vision; 25 US Patents

Charles Semba, M.D. Chief Medical Officer. SARcode (acquired by Shire), Genentech, Stanford

Carlos Schuler, Ph.D. Vice President, Technical Operations. S.E.A. Medical Systems, Incline Therapeutics, Talima, Anesiva, Nektar Therapeutics; 10 US Patents

Anne Rubin, MBA Vice President, Marketing. ForSight VISION4, Corventis, Medtronic

Judy Gordon, DVM Lead Regulatory Advisor. Owner, ClinReg Consulting

Tim Kahlenberg, MBA Acting CFO. Medtronic, Ardian, Xtent, LuMend, AneuRx, DVI

Co-Founders

Prof. Eugene de Juan, Jr., M.D. ForSight Labs Founder, Distinguished Chair at UCSF, Professor of Ophthalmology at Duke, Johns Hopkins and USC; over 200 publications

K. Angela Macfarlane, J.D. CEO, ForSight Labs and ForSight VISION4, The Foundry, TransVascular, AneuRx, VidaMed

Medical Advisors / Principal Investigators

Prof. Ivan Goldberg (Eye Associates, Sydney, AUS) (Phase 1 Principal Investigator) Prof. Kuldev Singh (Stanford University) Prof. James Brandt (University of California, Davis) (Phase 2 Principal Investigator)


Unique Value HUGE UNMET NEED in One of Largest Ophthalmic Markets

COMPELLING RESPONSE in Clinical Feasibility

FIRST-IN-CLASS Product Profile

Drug has ESTABLISHED EFFICACY

First of THREE MAJOR Anterior Segment MARKETS

Healthcare

ForSight Vision-5