Ampio Reports Interim Results From Optina Study For Diabetic Macular Edema

(RTTNews) - Ampio Pharmaceuticals, Inc.(AMPE) Monday reported interim results from the ongoing study of Optina as a treatment for Diabetic Macular Edema, a swelling in the yellow central area of the retina that may distort vision.

This interim analysis was conducted by an Independent Data Review Committee, comprising of a statistician and an ophthalmologist or retinologist, who were permitted to view the unmasked data from the trial. At least 30 percent of patients had reached the first 4 week time point and their clinical results were considered representative data for the trial. The study has enrolled 250 patients till date.

This IDRC decision will allow for the continuation and completion of the trial and, importantly, the immediate initiation of an open label extension study using this optimum dose of Optina for all patients who have completed the trial and wish to continue treatment for an additional 12 weeks.

The company said: "We expect the trial to be completed in the first quarter of 2014, and anticipate releasing top-line results as soon as they become available to Ampio. FDA has agreed to the 505 (b) 2 pathway for this drug which, given no significant safety concerns, could allow approval based on this single clinical trial."