Ampio Pharmaceuticals Inc. (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. 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.
Last year, the FDA granted Optina 505(b)(2) status and drugs designated under this pathway can be approved on a single trial.
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