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Ampio to request FDA for unmasked trial of DME treatment
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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.
Designed to investigate ultra-low-dose oral danazol (Optina, Ampio) for the treatment DME, the study’s primary endpoint was improvement of best corrected visual acuity and the secondary endpoint was improvement of central retinal thickness as seen on ocular coherence tomography.
In October 2013, the company initiated an open-label extension study for patients who requested a continuum of treatment for an additional 12 weeks. On June 25, Ampio announced it had closed enrollment in the clinical trial and was seeking further FDA guidance, according to the press release.