Ampio Pharma updates on path to FDA approval for DME drug Optina

14 October 2015

Shares of Ampio Pharmaceuticals (NYSE: AMPE) rose 5.5% to $3.09 as the company announced it had met with the Division of the Transplant and Ophthalmology Products of the Food and Drug Administration to discuss the results of the OptimEyes clinical trial of Optina (ultra-low dose danazol) and to seek guidance on the next steps to approval.

The guidance from the FDA was:

Ampio perform a confirmatory study on patients with diabetic macular edema (DME) who are refractory to the currently available drugs, which if successful, would qualify Optina as a rescue medication for patients who have no treatment options (failed available therapies).
The study will have significantly less patients than in the company’s previous OptimEyes study, based on power calculations and guidance received from the FDA, and will include approximately 80 patients randomized 1:1 between placebo and Optina.
Optina will be compared to placebo, not to other anti-vascular endothelial growth factor (VEGF) drugs, since we are addressing a population that failed these alternative treatments.
The FDA will consider improved vision as measured by BCVA (Best Corrected Visual Acuity), which is statistically and clinically meaningful, as determined by experts in the field.
The duration of the study will be a maximum of 12 months.

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