Ampio (Nasdaq: AMPE) says eye drug shows promise in trial

Orlando, FL 3/19/12 (StreetBeat) -- Ampio Pharmaceuticals Inc (Nasdaq: AMPE) said a mid-stage trial of its experimental drug to treat retinal swelling in diabetic patients was ended ahead of schedule based on positive interim data.

The company's drug Optina is being tested to treat diabetic macular edema -- the most prevalent cause of moderate vision loss in patients with diabetes.

Ampio said it plans to meet the U.S. Food and Drug Administration to decide the design of a late-stage trial, under section 505(b)2 regulation for repurposed drugs.

A 505(b)(2) application permits a company to obtain the FDA's approval by relying, in part, on the agency's findings for a previously approved drug, and thus reduces the time and development cost on the drug.

Optina is an oral ultra low dose of danazol, which was approved by the FDA in the 1970s for endometriosis -- a condition where cells from the uterus lining grow on other organs.

More recently, it was approved for a rare genetic disorder, hereditary angioedema, Ampio said.

Shares of the company closed at $2.68 on Friday on the Nasdaq.

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