Ampio Pharmaceuticals commences Optina Phase II clinical trial for diabetic macular edema

Ampio Pharmaceuticals, Inc. (OTC Bulletin Board: AMPE) today announced the initiation of a Phase II clinical trial of Optina™ for the treatment of diabetic macular edema, an early stage of diabetic retinopathy. Diabetic macular edema is responsible for most vision loss in patients with diabetes mellitus.

Ampio Pharmaceuticals has completed a formal agreement with St Michael's Hospital, Toronto, Canada as a final step for ethics board approval which is expected in the next few days.  "We are very excited to be commencing this trial and pending the final approval of the ethics board we will commence patient recruitment in the next weeks," stated Don Wingerter, CEO of Ampio Pharmaceuticals. Chief Scientific Officer, Dr. David Bar-Or added, "After accumulating in vitro and animal data, it is gratifying to begin treating patients for this debilitating disease."

Diabetic macular edema and diabetic retinopathy are complications of diabetes mellitus that occur in approximately one third of patients 10 years after the onset of diabetes and are rapidly growing causes of blindness worldwide. There is currently no effective oral medication to treat diabetic macular edema or diabetic retinopathy. Optina™ is a repurposed oral drug with an established human safety profile. Pre-clinical studies have shown the potential for Optina™ to significantly reduce diabetic macular edema in patients.