Ampio Pharmaceuticals, Inc. (NASDAQ: AMPE) announced oral dosing of the first patient in a 505(b)(2) clinical trial of the investigational drug Optina in diabetic macular edema. The trial will evaluate Optina™ in adults with recent onset diabetic macular edema. Last year, the FDA granted Optina™ 505(b)(2) status and drugs designated under this pathway can be approved on a single trial.
Michael Macaluso , Chairman and CEO of Ampio, commented "We dosed the first patient with oral Optina™' today. We believe that Optina has the potential to successfully treat patients afflicted with diabetic macular edema and satisfy a large unmet clinical need with a successful oral therapy. Based on the encouraging results from the Canadian study, we are very excited about Optina™'s potential to allow diabetic patients to avoid direct injections into the eye, a requirement of all other treatment regimens."
The 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. A total of 450 patients are expected to enroll. Patients are randomized to receive one of two oral 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.
Ampio Pharmaceuticals, Inc.