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.

TOPICAL EYE DROPS

• WASH OUT QUICKLY
• MULTIPLE DROPS/DAY, MOST MISS DROPS
• LEADS TO COMPLICATIONS COST $70B / YR

SOLUTION

• CONTINUOUS DOSING LENS
• IMPROVED EFFICACIOUS & CONVENIENT
• REDUCED COMPLICATIONS
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. Patients must administer multiple drops per day, and the majority of patients miss scheduled drops. If patients do take their drops, the majority of patients, both young and old, do not administer the drop correctly. Thus, patients are not receiving their medicine, leading to complications varying from uncomfortable, painful blinking to partial and complete loss of vision. OcuMedic’s continuous drug releasing lenses take the dosing of medication out of the patient’s hands leading to more efficacious and convenient therapy, decreasing complications and HEALTH CARE COSTS. In order to deliver as much drug as possible in such a short time frame, drops are usually highly concentrated leading to unwanted side effects as well as burning and itching sensations for patients. Many published studies estimate over 90% of drug delivered via drop enters the systemic circulation bypassing where it is intended to be delivered, to the eye and ocular tissue. Eye drops also have low amounts of harsh preservatives and sensitizers to provide extended, open shelf life that lead to discomfort, adverse reactions, and sensitivity issues for many patients.

Competitors and Competitive Advantage

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.