GREENWOOD VILLAGE, Colo., Jan. 22, 2013 /PRNewswire/ — Ampio Pharmaceuticals, Inc. (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 per BMI and 1.0mg per BMI per day) or placebo. After patients have completed 4 weeks of initial treatment, an interim analysis will occur to determine the best dose of Optina™. Following the 12 week active treatment period, there will be a further 4 week washout period to determine regression of treatment effect. The primary endpoint is improvement in visual acuity (VA), defined by responder status, compared to placebo. Secondary endpoints are 1) measurements of changes in VA and central macular thickness (CMT) in treated patients compared to placebo and, 2) safety and tolerability of the two Optina™ doses. Following treatment and washout, patients will be assessed for vision regression and a 12 week open label extension study will be offered to evaluate the duration of effect of the optimal dose. A total of 450 patients are expected to enroll.