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Ampio to request FDA for unmasked trial of DME treatment
Ampio Pharmaceuticals announced it plans to request that the U.S. Food and Drug Administration allow the company to unmask the OptimEyes 505(b)2 clinical trial, complete the analysis and present all of the data.The OptimEyes study included 359 patients with diabetic macular edema, and 432 eyes were evaluated. Fifty-five percent of the patients evaluated were no longer responding to anti-VEGF intraocular treatment, according to an Ampio press release.