Ampio Pharmaceuticals Begins Clinical Trial of Optina for Diabetic Macular Edema

Ampio Pharmaceuticals

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. (Logo: http://photos.prnewswire.com/prnh/20120516/MM09116LOGO) 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