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Patented Timed
Drug Delivery to
the Eye via Contact
Lens/Clear BANDAGE
Lens with Extended
Wear-
REPLACES EYE DROPS
CURRENT EYE DROP
MARKET $16B
(CAGR ~8%)
Problem & Solution
PROBLEM• < 5% of drops get to the targeted tissue in the eye• Treatment requires multiple drops/day >300 Drops
for post cataract treatment• Missed dosing costs $70B/complications
OCUMEDIC SOLUTION
✓Drug continuously delivered to targeted tissue✓Enhanced efficacy and convenience ✓Eye Care Professionals are trained to deliver
OcuMedic Therapy at the point of care – no patient compliance issues
✓Reduced Complications & Healthcare cost
OcuMedic Lens Extended Delivery vs. Drop
OcuMedic’s lenses have the potential to deliver 16x more drug per day with 1.3x higherbioavailability. Drops have short residence time caused by quick tear turnover.
201510Time (hours)
50
0
0.005
0.01
0.015
Bioavailability Lens/Eye drop* = 1.31
Mass Drug (µg) Delivered per Day Lens/Eye drop = 160.02
0.025
LensDrop
0.03
Efficacy, Controlled Release, & Safety Data
0
50
100
150
200
250
300
0 2 4 6 8 10 12 14 16 18 20 22 24 26
Drug
Con
cetr
atio
n in
Eye
Tea
r Flu
id (m
g/m
L)
Time (hrs)
Engineered Lens With Memory
Eye Drop (0.035% solution Zaditor®)
TiepApo, C.J. White, A.C. Paine, M.L. Voyles, M.K. McBride, M.E. Byrne. J. Control. Release. 157, 391-397, 2012
OcuMedic Lenses are ~100x more efficient drug delivery devices than topical eye drops–the current standard of care - No drug releasing lenses are in the market today
Controlled Duration of Drug Release
0
0.2
0.4
0.6
0.8
1
0 5 10 15 20 25 30 35
Frac
tio
nal
Bro
mfe
nac
Re
leas
e
Time (days)
3:1 M/T 25:1 M/T
15 days vs 30 day release
Higher M/T Ratio (Monomer/Template Ratio) of lens Polymer Structure Leads to more "Memory" & Longer Release Period
A. Tieppo, K. M. Pate, M. E. Byrne. European Journal of Pharmaceutics and Biopharmaceutics. 81, 170 -177, 2012.
Anti-Inflammatory Drug Eluding LensBromfenac “First Line” eluding anti-inflammatory lens made with silicone Hydrogel (80% of used lenses) for treatment of postoperative inflammation and reduction of pain after cataract and Lasik surgeries
Wear Time 7 Days
Indications• Cataract • LASIK • Corneal Abrasions
First Product in Development
Drug Eluding Lens to treat Dry Eye Syndrome (DES)
Hyaluronic acid/HPMC and cyclosporine - eluding lenses are in development*
Today DES is considered the leading cause of US patient visits to Eye Care providers: 20-30M people have early signs & symptoms of DES
Global revenues in the dry eye treatments market is expected to climb from $4.6 billion in 2018 to $6.2 billion in 2023**
* M. Ali, M.E. Byrne. Controlled Release of High Molecular Weight Hyaluronic Acid from Molecularly Imprinted Hydrogel Contact Lenses. Pharmaceutical Research 26(3), 714-726, 2009
** C. White C, M. McBride, K. Pate, A. Tieppo, M.E. Byrne. Extended Release of High Molecular Weight Hydroxypropyl Methylcellulose from Molecularly Imprinted, Extended Wear, siliconee Hydrogel Contact Lenses. Biomaterials (32):5698-5705, 2011.
Following Products in Development
Milestones
Product Candidate Indication Stage of Development
In Vitro In Vivo Pre-IND Phase I Phase II
OM002 - NSAID - eluding anti-inflammatory extended wear lens
Cataract/LASIK/Corneal Abrasion
OM004 - Cyclosporin and Hyaluronic Acid/Comfort Agent - eluding extended wear lens
Dry Eye Syndrome
OM006 - Prostaglandin Analog, Latanoprost -eluding extended wear lens
Glaucoma
OcuMedic Commercialization Strategy: Exit at Phase II - In Dialogue with Several Potential Acquirers
OcuMedic Platform Technology
OcuMedic's novel technology produces lens polymers, in association with drugs of choice, creating polymeric networks with small pores “macromolecular memory”, unique for each drug, enabling:
• Enhanced affinity of the drug and polymer (high payload)• Continued and controlled diffusion of the drug
Controlled delivery of drugs from contact lenses has been the subject of investigation for over 50 years
Value Proposition
List of The US/EU Issued Patents (Valid through 2026-30)Patent # US 8,404,271 B2 Contact Drug Delivery System (broad)Patent # EP 1848749 Contact Drug Delivery System (broad)
Patent # US 9,238,003 B2 Extended or Continuous wear silicone Hydrogel Contact Lenses for the Extended Release of Comfort Molecules
Patent # US 8,388,995 B1 Controlled and Extended Delivery of Hyaluronic Acid and Comfort Molecules via a Contact Lens Platform
Patent # US 8,349,351 B2 Contact Drug Delivery System
Patent # US 8,349,352 B2 Therapeutic Contact Lenses with Anti-Fungal Delivery
OcuMedic has 10 issued Patents and "Freedom to Operate" legal opinion, enabling controlled release of drugs to the eye: 5 US, 2 Canada, 1 Mexico, 1 India, 1 EU (broad)
Recent Development Updates
In Q3-2019, OcuMedic achieved 2 Financial and Strategic Partnership Milestones, propelling it to the next phase of regulatory approval and commercialization:
In July 2019 OcuMedic expanded its global presence. The company was awarded Chinese Municipal Government financial support to establish a subsidiary/Joint venture in the province of Shandong, China. OcuMedic will work with an affiliate private company, INNO LINK, to establish the entity, identify collaborative partners for manufacturing, regulatory and marketing and sales in the greater China
In August 2019, OcuMedic finalized an exclusive vertical integration agreement with Gelest Inc., a major global supplier of materials to the contact lens industry. The arrangement included a “Design-in Supply Agreement” using Gelest custom chemistry formulated for specific drug delivery under OcuMedic IP for a contact lens/corneal bandage. Gelest Inc. also participated in the Series A round of financing.
Series A Financing:• Lead investment by Rowan Innovation
Venture Fund • Pre Money valuation $7M• Price/Share $1.00• Participating Preferred Offering $5-7M
(Minimum$25K) With (50% warrant coverage on investment @exercise price of $0.01)
Use of Proceeds:• In vitro Dry Eye Study • FDA In vivo Navigation Study – Q 4 2019• Phase 1-2 Human Studies - 28 mo• Exit/Partner Identification
Investment Highlights
LeadershipKeith Ignotz, MBA - President & CEO
Co-founded & Sold Freedom Meditech as President & COO,
Onset President & CEO of DiaKine Therapeutics,
Co-founded SpectRx as President & COO
Senior VP Allergan Humphrey , division of Allergan
Paul Byrne, MBA - Co-Founder, CBO & CFO
20+yrs McKinsey, PNC Bank Executive, experience on corporate
strategy, ops, distribution, sales
Mark Byrne, Ph.D. - Founder, CTO
16+yrs Distinguished Chemical & Biomedical Engineering Professor & Founding Dean/Dept
Head, Internationally recognized expert biomaterials/drug delivery, manage College faculty/staff
of 100+ people, 90+ peer-reviewed publications, NIH & NSF panel reviewer, 350+
invited/conference talks, 12 patents, 17 mentored PhD and 100+ Engineering research students
Fredrick Cahn, Ph.D. - Acting CRO30 years of experience in biomedical engineering/product development, consulting for Regulatory & Reimbursement with an ophthalmic focus
Scientific and Advisory Board
Mr. Steve Martin Advisory BoardPrior Founder of CIBA Vision Optics (now part of Alcon) and CIBA Vision Ophthalmics (now part of Novartis) At CIBA, he and his team grew sales to over
$1.2 Billion and led >6,000 employees.
Lynn Winterton, Ph.D. Scientific Advisory BoardPrior Global Head of R&D CIBA Vision, 30+yrs developing & commercializing multiple
contact lenses on market today
Paul Karpecki, O.D. Scientific Advisory BoardChief Clinical Editor of Review of Optometry, 20+yrs Director of Corneal Surgery
Steve Hamilton, M.D. Clinical AdvisorBoard Certified Ophthalmologist, 18+yrs specializing in corneal disease and surgery
Mr. Ron Dadino Regulatory AffairsPrior J&J VP leading regulatory strategy for all combination products , 33+yrs
in pharma & medical device sector, led global approval for first drug/stent
combination device >$1B in sales
Gary Novack, Ph.D. Regulatory AffairsPresident of PharmaLogic, 30+yrs in pharma R&D, consultant 400+ pharma
and medical device firms on regulatory strategy
Company Highlights
Experienced Management Team
Strong Worldwide Patent Portfolio - valid until 2030
Strategic Partners Gelest / INNO LINK China for…Growing Markets
Reimbursement at FDA approval with CPT code 92071
Staged to advance to Phase 1-2 Clinical Trials
STRATEGIC TAKE OUT EXIT BENCHMARKS at Phase II
several potential acquirers :
Ophthalmic asset exit Examples:
Eye Gate licensed to B&L Valeant at $135M
Forsight Vision5 licensed to Allergan at $95M