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News Breaks
February 27, 2013
05:52 EDTAMPEAmpio initiates clinical trial of Optina in DME, first patient dosed
Ampio Pharmaceuticals announced oral dosing of the first patient in a 505b2 clinical trial of the investigational drug Optina in diabetic macular edema, or DME. The trial will evaluate Optina in adults with recent onset diabetic macular edema. Last year, the FDA granted Optina 505b2 status and drugs designated under this pathway can be approved on a single trial.
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February 25, 2015
07:17 EDTAMPEAmpio's Ampion for osteoarthritis shows positive top-line results
Ampio announced results of the double-blind, multiple injection, vehicle controlled STRUT study at 20 weeks. The forty patient randomized phase of the STRUT study was conducted to assure that multiple injections of Ampion were safe and effective. Each patient received three 4 mL intra-articular injections of Ampion or saline at baseline, 2 weeks and 4 weeks. There were no drug related serious adverse events. The primary endpoint that is required for FDA approval, WOMAC A pain score, improved by 64% from baseline to 20 weeks. Responder rate for Ampion was 79% compared to 47% of saline patients. Data for the larger, multi-site STRIDE study, a similar design to STRUT study, is expected in Q2.

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