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June 25, 2014
08:11 EDTAMPEAmpio closes enrollment in OptimEyes study for presentation to FDA
Ampio Pharmaceuticals has informed the Transplant and Ophthalmology Division of the FDA of its intent to reduce the patient sample size in the OptimEyes Study for the treatment of Diabetic Macular Edema - oral treatment with Optina. The present enrollment of over 355 patients provides an adequate power of 88%, which the company believes is more than sufficient for statistical evaluation. By reducing the patient sample size, the company expects data by Q4.
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