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Ampio stops OptimEyes Study enrollment, cites early benefits
Ampio Pharmaceuticals announced it will halt enrollment to the OptimEyes Study with fewer participants than originally intended, citing early positive responses to ultra–low-dose danazol for the treatment of diabetic macular edema, according to a company press release.The Transplant and Ophthalmology Division of the U.S. Food and Drug Administration has been notified of the changes, which will reduce enrollment from 450 patients powered at 95% to the present enrollment of more than 355 patients, providing a power of 88%, according to the press release.