Ampio Pharmaceuticals, Inc. Announces Updates On the Regulatory Path for FDA Approval of Optina™, an Oral Treatment for Diabetic Macular Edema (DME)

Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) today announced that Ampio met with the Division of the Transplant and Ophthalmology Products of the FDA to discuss the results of the OptimEyes clinical trial of Optina™ and to seek guidance on the next steps to approval. The guidance from the FDA was: Ampio perform a confirmatory study on patients with 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 our 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. A large number of patients who suffer from DME and who are either non-responsive to available therapies or who have contra-indications to intra-ocular therapies (such as glaucoma, post vitrectomy etc.), have very limited treatment options and are progressing toward blindness. The FDA acknowledged that Optina™ qualifies as a drug in the 505(b)2 regulatory pathway, thus the safety profile for Danazol is already established at doses more than ten times higher than the Optina™ dose.