Technology & Competitive Advantage

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.

Competitors and Competitive Advantage

Currently topical eye drops, the standard of care controlling over 90% of the ocular pharmaceutics market, are inefficient and inconvenient as drops are washed from the eye in 30-45 minutes with substantial peaks and valleys in drug concentration.

The US ophthalmic prescription drug market is highly competitive and includes leading brand and generic providers for eye drops. The leading marketed product suppliers are Novartis (Zaditor- ocular allergy, Vitravene-CMV retinitis), Alcon (Tobradex-infection and inflammation; Vigamox-infection, Azopt-glaucoma), Allergan (Restasis-dry eye, diquafosol-dry 3%), Bausch & Lomb (Alrex, Lotemax-Inflammation and Allergy), Merck & Co (Cosopt-glaucoma), Pfizer, Isis, Santen, and QLT. There are 5 major global contact lens manufacturers: Vistakon (Johnson & Johnson), CIBA Vision (Alcon), Bausch & Lomb (division of Valeant Pharmaceutical), CooperVision (Division of Cooper Companies), and Ocular Sciences, Inc. There have been mergers in the eye care space between pharma and contact lens manufacturers. For example, Valeant pharmaceuticals acquired Bausch & Lomb in 2013 and Novartis, who owned CIBA Vision, acquired Alcon in 2011. Consolidations and re-positioning with-in the segment continues.

Historical Challenges & Achievements Supporting Development Toward Commercialization

Controlled release from contact lenses has been the subject of discussions and investigation for fifty, (50) years. Previous methods suffered from either poor control of the release profile or inadequate drug loading with the overwhelming majority of researchers demonstrating both problems. Thus, there are no products on the market today. With the OcuMedic’s patented method memory for the drug is produced during polymer synthesis where monomers are complexed non-covalently to the drug and crosslinked into a hydrogel matrix.

Upon removal of the drug, macromolecular memory sites remain within the hydrogel with affinity for the drug. The drug’s heightened interaction with these memory pockets enhances its loading and SLOWS its transport within the hydrogel despite comparable free volume of drug transport. It has been shown that the extension of release has a strong dependence on mimicking biological recognition in the design exploiting the chemical diversity and amounts of monomers in relation to the drug. Thus, OcuMedic’s can literally…. DIAL IN THE RELEASE OF DRUG FROM THE LENS OVER TIME delivering a therapeutic concentration of drug payload for the duration of wear.