Therapeutic Vision, Inc. — Department of Health and Human Services SBIR Phase II: N

Description

DESCRIPTION provided by applicant Diabetes mellitus DM in dogs is characterized by a rapid onset of bilateral cataracts that results in vision loss that can only be restored by costly cataract surgery We have developed a topical aldose reductase inhibitor ARI formulation called KinostatTM that prevents the development of diabetic cataracts and thus eliminates the need for cataract surgery We have completed of FDA requirements for clinical approval of this drug and the goal of this grant application is to obtain additional funds so that the remainin FDA regulatory requirements can be successfully completed With SBIR Phase I funding we have established that KinostatTM prevents the clinical development of cataracts in diabetic dogs when administered daily by their owners With SBIR Phase II funding we have completed the FDA required toxicological study for KinostatTM and developed both a pilot plant CGMP synthesis of the active ARI and the CGMP Pilot Batch Manufacture run for KinostatTM We have also initiated a multicenter placebo controlled clinical trial of KinostatTM with FDA concurrence at different locations in the U S Based on the scientific merit of these results and the fact that this represents the first drug for the prevention of diabetic cataracts the FDA has granted us user fee waivers associated with our New Animal Drug Application as well as a MUMS designation that waives additional user fees associated with report submissions and fast tracks the development of KinostatTM for the commercial veterinary market The anticipated commercial availability of KinostatTM will provide owners of DM companion pets the choice of either medically preventing cataract development through the daily administration of KinostatTM or paying for costly cataract surgery that will inevitably be required as a result of DM Once established for diabetic dogs we hope to transition the drug for human use for alleviating the need for cataract surgery in young diabetic children PUBLIC HEALTH RELEVANCE This proposal seeks funding to complete the FDA regulatory requirements for approving KinostatTM for the ophthalmic veterinary market KinostatTM is a topical aldose reductase inhibitor formulation that when applied daily prevents the clinical development of cataracts in diabetic dogs and thus eliminates the need for cataract surgery Once established for diabetic dogs we hope to repurpose the drug for human use alleviating the need for cataract surgery in young diabetic children