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Avenova (formerly i-Lid™ Cleanser)
A NEW DIMENSION IN LID AND LASH HYGIENE
Ron Najafi, Ph.D.
Chairman & CEO
NovaBay Pharmaceuticals, Inc. email: [email protected]
(New York Stock Exchange: NBY)
The San Francisco Bay Area
Home to NovaBay Pharmaceuticals (A view from our facilities)
NovaBay Pharmaceuticals Employees: 28, founded in 2000 by Ron Najafi, Ph.D. (chemist)
NovaBay Dedicated Sales Force: 39, all across the US
Location: Emeryville, CA
Capital Structure: Public Company, listed on NYSE: NBY
Focus: Non-Antibiotic Antimicrobials
Marketed products (Neutrox platform)
– Avenova: (formerly i-Lid™ Cleanser ) . Lid & Lash Hygiene, Blepharitis,
MGD and Dry Eye.
– NeutroPhase: Diabetic Ulcer, Venous and Pressure Ulcers, including NF)
– CelleRx: Burn associated with Post Laser Resurfacing
Pre-Market Products (Aganocide platform)
– Bladder Irrigation Solution for patients with Spinal Cord Injury and recurrent
blockage and encrustation
– Skin Infection (Impetigo and Acne)
Global Partnerships: PBE (in the US), IHT (USA), Galderma (France), Virbac
(France), Pioneer Pharma (China and Southeast Asia), Shin Poong (Korea), Biopharm
(North African and Middle East)
“The Most Under-
recognized
The Most
Underappreciated
The Most Undertreated
disease
in Ophthalmic Care”
Anatomy of Eye and Lid and
Meibomian Gland
Blepharitis: Infection and
Inflammation of EyeLid
Blepharitis Causes:
Meibomian Gland Dysfunction (MGD).
Gland Oil Keep
the water from
evaporating &
preventing Dry
Eye.
Expressing the Meibomian Gland
Shows Dysfunction present
Tooth Paste
like
consistency is
bad
Doctor is
pressing
against lower
eye lid
Blepharitis / Meibomian Gland Dysfunction/
Associated Dry Eye / Pre-Operative Lid
Hygiene
Chronic lid & lash hygiene
- 24 million blepharitis patients
- 6.5 million MGD dry eye patients
- 3 million cataract patients
- 1.5 million refractive surgery patients
Avenova (formerly i-Lid™ Cleanser) for Conditions of the Lids and Lashes
Proprietary Technology
– Neutrox : NovaBay Proprietary Pure 0.01% Pure hypochlorous
solution in saline
– No bleach impurities, which is present in Dakin and Dakin-like
solutions
– No resistance expected based on novel mechanism of action
Significant Market / Poorly Served
– Eyelid hygiene therapy, part of the treatment for blepharitis
– Currently marketed products have little to no benefit
– 4% of 18 – 22 year olds
– 71% of 65+ year olds
Why Control of Lid Flora Matters?
Blepharitis
MGD with secondary staph
overpopulation
Pre-op surgical prophylaxis
– Refractive
– Cataract
– Retinal
Contact lens wear
Does not generate
Resistance
Mechanical Debridement
Anti-Toxin Anti-biofilm
Activity
Bacterial Removal ✓
✓ ✓
✓
✓
Blepharitis
MGD
Multifactorial
Chronic
Disease
Affects
Quality of life
Does not generate
Resistance
Mechanical Debridement
Anti-Toxin Anti-biofilm
Activity
Bacterial Removal ✓
✓ ✓
✓
✓
Omega 3
Fatty Acid
Omega 3 Fatty Acid,
Rich in EPA & DHA
Eicosapentaenoic Acid (EPA), 20 carbons and 5 double bonds.
Docosahexaenoic Acid (DHA), 22 carbons and 6 double bonds.
Why Neutrox™ ?
PURE Hypochlorous Acid [ HOCl ]
Cl
O
H
Neutrox™ (NovaBay’s Proprietary Pure Hypochlorous Acid)
Excellent
activity
against a
broad range
of pathogens
Fast acting
onset of
activity
Effective
against
pathogens
commonly
found on the
lids & lashes
20
Avenova™ demonstrated excellent activity in solution
compared with the market leading lid and lash cleanser*
Organism S. aureus MRSA S. epidermidis S. haemolyticus P. acnes
NovaBay
Avenova®
< 1 minute < 1 minute
< 1 minute
< 1 minute
< 1 minute
OcuSoft® Lid
Scrub Foam
> 30 minute > 30 minute > 30 minute > 30 minute > 30 minute
Avenova has higher Therapeutic
Index than Betadine
• Fast acting onset of microbial activity
• Extremely low toxicity levels
• 1,000 times less toxicity than Betadine®
21
Agent Tested Hypochlorous Acid
.01%
Betadine® Surgical
Scrub (Povidone-
iodine, 7.5%)
Nontoxic
Dilution
1:10 1:10,000
Time to 4 log10
kill
<1 minute >24 hours
Tested Against S. aureus ATCC 33591
*Antimicrobial Activity Comparison of Pure HypoChlorous Acid (0.01) with other Wound and Skin Cleansers at Non-Toxic
Concentrations, Russell Hoon, Suriani Abdul Rani, Ramin Najafi, Lu Wang, Dmitri Debabov; SAWC Spring 2013 and WHD
2013
Research on Biofilms
22
• Hypothesis is that bacterial biofilm plays a significant role in delaying wound healing
(Mertz – Wounds – May 2003)
A scanning electron micrograph of a porcine wound surface with Staphylococcus aureus biofilm (6000X)
23
NovaBay Avenova® has Potent Anti-biofilm
Activity Compared to Saline
• In vitro Biofilm of P. fluorescens breaks up upon
introduction of Avenova®
SALINE (control) NovaBay Avenova
Hypochlorous Acid
Hypochlorous acid (HOCL) released from neutrophil cells
Part of body’s immune response
Kills microorganisms
Neutralizes toxins released from pathogens and inflammatory mediators – helps suppress the body’s
inflammatory response
24
neutrophil
cell
HOCL
Representation of bacteria-produced
toxins which attack human cells
26
Representation of human cell response
to bacteria-produced toxins
27
Representation of the Mechanism of
Action of Hypochlorous .01% in In-Vitro
Models
Kills bacteria
Blocks bacteria produced toxins
Blocks human cell produced pro-inflammatory mediators
Dx of DES and Blepharitis:c/o irritation, pain; used Maxitrol drops and
ointment for 2 wks + warm compress and eye scrub with Baby Shampoo. Was
shown how to clean his lids and lashes in the office with Saline.
Still returned 2 wks later with similar symptoms. Maxitrol was d/c’d and
Avenova given. After 2 wks RTC with improved symptoms and improved
clinically on Exam.
After Use of Baby Shampoo After use of Avenova
Typical Blepharitis Case
Vision:
– OD 20/30
– OS 20/20-
TAP: OD 21 OS 23
Exam:
– Blepharitis
– Debris on lashes
– Conjunctival
hyperemia
• From end of 2008 until end of 2012
• Patient was seen 25 times
• Between visits he would call and get Rx for Ab.
• Received courses of:
• Bacitracin, neomycin, polymyxin, tobradex,
maxitrol, zylet, oral doxy, used Ocusoft.
• Patient developed skin ulcer from Ocusoft use
• 10% of patients who use these over the counter
eye lid scrubs will develop contact dermatitis
• Eczema type reaction due to their detergent
based components
Patient Case History: Chronic Blepharitis
32
Avenova™
(formerly i-Lid Cleanser)
33
with
Neutrox
as preservative
Avenova™
(formerly i-Lid Cleanser)
Severe Ocular Surface Disease
with Demodex
After 3 wks of use of Avenova™
Patients with acute or early stage meibomian gland
disease have a frothy tear film, or bubbles, which is
evident here at the lid margin.
Staph aureus is a consistent Lipase producer
Breaking down natural lipids (triglycerides) from
Meibomian Gland
Bacteria Lipase activity is responsible for the
breakdown of lipid to fatty acids – [Invest. Ophthalmol. Vis. Sci.April 1986 vol. 27 no. 4 486-491]
Assuming Lipase causes saponification of lipid
and conversion to fatty acid and soap. Can
Avenova breakdown Lipase and prevent
saponification (soap making)
Lipase
Methyl Resorufin
Lipase Viability Assay
Lipase Substrate
Method used:
1) We treated Lipase with the test article
2) We looked for Lipase viability next
Avenova™(formerly i-Lid Cleanser)
inactivates Bacterial Lipase
Chronic use of antibiotic
will result in antibiotic
resistant strains
Product Comparison (Ingredients)
50
OCuSoft SteriLid Oasis
Lid
and
Lash
LIDCLE
NZ
VisiClean
se
Eye
Scrub
Ingredient
s
Hypochlorous
acid, saline
Water , PEG-
80 Sorbitan
Laurate ,
Sodium
Tricedeth
Sulfate ,
PEG-150
Distearate ,
Disodium
Lauroamphod
iacetate ,
Cocamidopro
pyl
Hydroxysultai
ne , Sodium
Laureth-13
Carboxylate ,
Sodium
Chloride ,
Quaternium-
15
Water , PEG 80
, Sorbitan
Laurate ,
Sodium
Trideceth
Sulfate ,
Cocamidopropyl
Betaine ,
Sodium
Lauroamphoace
tate , PEG 150
Distearate ,
Sodium Laureth
13 Carboxylate ,
Linalool Oil ,
Hepes Acetate ,
Sodium
Perborate
Monohydrate ,
Panthenol ,
Allantoin
(Comfrey Root)
, Sodium
Chloride , Tea
Tree (Melaleuca
Alternifolia) Oil ,
Tris EDTA ,
Water,
Poloxamer,
Polyethylen
e,Glycol,Bo
rate,Hyalur
onan,Methy
lparaben,
Carbopol
940
non-foaming
pH balanced
formulation of
non-ionic
surfactant in
purified water
Water,
Cocamidopropyl
Betaine, PEG-
80 Sorbitan,
Laurate,
Sodium
Trideceth
Sulfate, PEG-
150 Distearate,
Aloe,
Barbadensis
Leaf Extract,
Chamomilla
Recutita
(Matricaria)
Flower, Extract,
Cucumis
Sativus
(Cucumber)
Fruit Extract,
Althaea
Officinalis, Root
Extract, Avena
Sativa (Oat)
Kernel Extract,
Tetrasodium
EDTA, Citric
Water USP
(Purified),
PEG 200
Hydrogenated
Glyceryl
Palmate,
Disodium
Laureth
Sulfosuccinat
e,
Cocoamidopr
opylamine
Oxide, PEG
80 Glyceryl
Cocoate,
Benzyl
Alcohol,
Edetate
Disodium
To Open an account contact:
NovaBay by calling:
1-800-890-0329
Retail to patients: $30
If used according to instructions:
1st bottle will last 2 weeks
(2X per day application)
2nd bottle will last 1 month
(1X per day application)
Thank you!