DiabetesSource

Ampio Pharmaceuticals, Inc. announced today the signing of a contract with St. Michael's Hospital, Toronto, Canada to conduct, "A Randomized, Placebo-Controlled, Parallel Treatment Group, Double-Masked Study to Evaluate the Efficacy and Safety of Three Doses of Oral OptinaTM in Adult Subjects with Diabetic Macular Edema". This phase II trial will seek the optimal content of each dose using industry standard methods of Optical Coherence Tomography (OCT) and Best Corrected Visual Acuity (BCVA). The data will be used to construct a pivotal phase III trial for submission to regulatory bodies in the USA, Europe and Asia.

Don Wingerter, CEO of Ampio Pharmaceuticals noted that, "This is a very important step in our strategy to bring medications to the market quickly. As OptinaTM is a 'repurposed' drug with existing manufacturing and a long-established safety profile at higher doses, our time to market outside the U.S. may be as soon as next year, which could provide near-term hope for millions of patients who experience this debilitating condition."

The Principal Investigator, Dr. Shelley Boyd, Clinical Scientist, Department of Ophthalmology, St. Michael's Hospital, Toronto, Canada and Assistant Professor, Department of Ophthalmology and Visual Science, University of Toronto, is a world renowned researcher into clinical therapies for the causes of loss of vision. "I am thrilled to be involved with this project for the treatment of Diabetic Retinopathy," said Dr. Boyd. "There is a tremendous unmet need as there is no oral medication for this blinding complication of Diabetes Mellitus."

Dr. David Bar-or, founder and Chief Scientific Officer of Ampio Pharmaceuticals, stated, "It is very gratifying to see discoveries translate from the laboratory to the clinical setting. We are very excited by the results of our in vitro data and look forward to validating the optimal therapy in patients."

About Ampio Pharmaceuticals, Inc.
Ampio Pharmaceuticals, Inc. develops drugs to treat metabolic disease, eye disease, kidney disease, inflammation and CNS disease. The company's product pipeline includes certain FDA approved drugs, now targeted at new clinical indications protected by Ampio intellectual property, and new molecular entities ("NMEs"). The company's development of new uses for previously approved drugs is expected to result in reduced approval timelines, lower costs and decreased risks of clinical failure. The company is actively exploring partnership, licensing and other collaboration opportunities to maximize Ampio's near term and long term product development programs.