FDA Accepts Ampio Pharmaceuticals IND for Optina for Treatment of Diabetic Macular Edema
Ampio Pharmaceuticals (NASDAQ: AMPE) announced today that the FDA has accepted the Company's IND for Optina™ for the treatment of diabetic macular edema (DME). Ampio plans to commence enrollment in a clinical trial in the first quarter of 2013. The FDA granted Optina™ 505(b)(2) status in July, 2012. Drugs designated under this pathway can be approved on a single trial.
Michael Macaluso, Chairman and CEO of Ampio, commented "Having an active IND for Optina™ is an important milestone in the advancement of our lead compounds from our pipeline. This is a significant step in the approval process through an agreed upon 505(b)(2) pathway with the FDA. DME is a devastating complication of diabetes and we believe, based on a previous phase 2 study performed in Canada and extensive in vitro data, that Optina™ has the potential to become a valuable treatment option for DME. "
The planned multicenter trial is designed to evaluate the safety and efficacy of oral Optina™ compared with placebo given over a period of 12 weeks in adult patients with DME. Patients will be randomized to receive one of two doses of Optina™ (0.5mg