Technology & Management

Prolonged Ocular Therapy

In summary the OcuMedic technology can be viewed as based on these principles:

• Choice of appropriate polymer chemistry (i.e., monomers/macromers) and templated polymer network formation makes possible affinity between drug and multiple polymer chains within the polymer network due to non-covalent interactions (ionic interactions, hydrogen bonds, hydrophobic forces, Van der Waals forces)
• A polymer network with functionalized small pores impedes and controls the diffusion of drug through the network.
• To obtain a suitable polymer structure, a controlled templated polymerization is important.
• Creating macromolecular memory by including the drug during polymerization leads to enhanced affinity of drug and polymer.
• Enhanced high affinity of drug and polymer has two effects:
o it increases the quantity of drug that can be bound increasing the therapeutic payload to sustain longer releases and
o it further slows down and controls the drug the diffusion.
The overall objective is to obtain an approximately constant or steady release rate (i.e., “zero order”).

OcuMedics Technology

The patented technology was developed by Mark Byrne, Ph.D., Distinguished Professor of Chemical and Biomedical Engineering & Founding Head of the Biomedical Engineering Department/Founding Dean Health Engineering and Science at Rowan University. Dr. Byrne serves as Co-founder of OcuMedic and Chief Technical Officer of the company. The technology rests on 10 issued patents, and a recent Freedom to Operate (FTO) opinion. Efficacy has been proven in animal models.

The technology is based on a novel therapeutic contact lens, made from the most widely used lens material, silicone hydrogel (SiHy), capable of controlled release of first line ophthalmic agents. The platform technology is tested for a use with anti-inflammatory and antibiotic agents, as well as 10 other drugs. It is also an ideal platform for treatment of dry eye especially episodic flairs.
Controlled release from contact lenses has been the subject of investigation for 50 years. Ophthalmologists have attempted to deliver therapeutics to eyes by soaking lenses in drugs, gaining negligible results. Previously methods suffered from poor control of the release or inadequate drug loading, with the overwhelming majority displaying both problems.

OcuMedic’s technology is unique in that the drug of choice is non-covalently linked with the monomers of the hydrogel matrix during synthesis. This creates a polymeric networks with small pores or “macromolecular memory”, unique for each drug. The patented technology allows for enhanced affinity of the drug to the polymer and high payload without preservatives. Therefore, OcuMedic can “DIAL IN” the release of the drug from the lens over time, delivering a therapeutic concentration of the drug of choice for the duration of wear. Key Milestones: Our main achievement has been the development of the enabling breakthrough technology which allows for the sustained kinetic of drug release in a SiHy lens for the duration of wear, while maintaining lens properties such as; modulus, optical clarity, thickness, and oxygen diffusivity. Over the past 18 months, OcuMedic has secured the World-Wide licenses from Auburn University including 9 issued patents in the US and one recently issued with broad claims in Europe numbering now 10 issued patents.

Meeting an Unmet Need: Current topical eye drops wash out quickly with only ~5% of the drug reaching the desired site. Most eye drop therapeutic regimens require multiple applications per day with poor patient compliance costing over $70 billion per year in complications. Other extended release products such as inserts are uncomfortable and can expulse. Punctual plugs can come out without the knowledge of the patient. As such, these products have not found wide-spread use.

OcuMedic’s solution is continuous dosing using contact lenses which may have vision correction, or a clear contact bandage providing more efficacious and convenient therapy DECREASING COMPLICATIONS and reducing HEALTH CARE COSTS.

Currently, optometrists are authorized to dispense diagnostic and therapeutic agents, under-Medicare and state licensures. With the advent of “co-management” patients undergoing cataract surgery (4million/year) or LASIK (800K/year), and post-corneal abrasions (1million/year), the 33,000 practicing optometrist along with the 19,000 practicing ophthalmologists are ideally suited and trained to deliver OcuMedic’s therapy both as the prevailing optometric contact lens. OcuMedic’s technology will provide clinicians a powerful, new tool to treat patients.

Keith D. Ignotz, MBA kignotz@ocumedics.com P 404-444-6030
Mark Byrne, PhD mbyrne@ocumedics.com P 334-332-5693

OcuMedic Management Team

Keith Ignotz, MBA

President & CEO

Co-founded Freedom Meditech as President & COO, Onset President & CEO of DiaKine Therapeutics, Co-founded SpectRx as President & COO took public. Senior VP Allergan Humphrey $100M division of Allergan.

Dr. Mark Byrne

Co-founder & Chief Technical Officer

Distinguished Professor of Chemical and Biochemical Engineering & Founding Head of the Biomedical Engineering Department at Rowen University

Dr. Paul Karpecki

Lead Optometric Advisor

Lead optometric advisor and member of its Scientific Advisory Board. His role with the company is in the development of its activities, communications, meetings and strategies relating to research and product development.

Paul Byrne

Co-founder of OcuMedic

CBO 20+yrs McKinsey, PNC Bank Execu7ve, experience on corporate strategy, ops, distribu1on, sales. Mr. Byrne is the Co-founder of OcuMedic •  MBA, Harvard

ADVISORY BOARDS & CONSULTANTS

Mr. Martin

Advisory Board

Mr. Martin is a nationally recognized and accomplished executive and entrepreneur with over 30 years of experience in the optical and medical device industry. He is the founder of Ciba Vision Optics, now part of Alcon and Ciba Vision Ophthalmics, now part of Novartis. While at Ciba Vision, he and his team grew sales to over $1.2 Billion and led more than 6,000 employees. Mr. Martin is an accomplished visionary who brings a wealth of optical and medical device knowledge as well as entrepreneurial expertise to OcuMedic

Lynn Winterton, Ph.D

Scientific Advisory Board

Lynn Winterton, Ph.D. –– Scientific Advisory Board Member. (BVG Solutions-Consulting) Prior Global Head of R&D CIBA Vision with over 30 years’ experience developing and commercializing multiple, innovative contact lenses on the market today in numerous countries. Dr. Winterton was also Global Director of Strategic Partnerships at CIBA Vision and has key regulatory and manufacturing experience in the contact lens space. Upon completion of OcuMedic’s first financing, Dr. Winterton will be issued 3% equity in common stock.

Clifford H. Price

Director of Communications
 Consultant

San Diego, CA Mr. Price is a nationally award-winning professional with 30 years of experience leading corporate sales, marketing and internal communications for start-ups to multi-million dollar companies across diverse industries throughout the world. He is a respected leader of creative teams, multimedia divisions and corporate communications departments within his own portfolio of firms and direct client relationships. He is a respected expert in the technical, conceptual and content development.

Timed Drug Delivery to the Eye Via Contact Lens/Clear BANDAGE Lens with Extended Wear

Ron Dadino –– Consultant, Regulatory Affairs. (Dadino Consulting) Prior J&J VP of Product & Process Scientific Solutions leading regulatory strategy for all combination products across J&J. He has more than 33 years in pharma and medical device sector. The former J&J (Cordis) VP of Combination Product Development led global approval for first drug eluting stent combination device resulting in $1B in sales. Consulting agreement is underway and should be executed within 30 days of the date of this report. The current terms of the proposed consulting agreement are as follows: 12 month term with successive renewal unless terminated by either party; compensation $300-$150 per hour with payment upon qualified financing.

CLINICAL ADVISISORY BOARD
Steve Hamilton, MD –– Clinical Advisor, Board Certified Ophthalmologist, specializing in corneal disease and surgery, currently in private practice with over 18 years of experience.

Meredith Voyles DVM –– Pre-Clinical Advisor, Board Certified Veterinary Ophthalmologist, Previously Professor of Ophthalmology at Auburn University, currently in private practice with over 15 years of experience, with specialty training treating corneal disease as well as preclinical studies.