Ampio Pharmaceuticals, Inc. (Nasdaq: AMPE), a biopharmaceutical company developing innovative proprietary drugs for inflammation, eye disease, kidney disease, CNS disease, metabolic disease and male sexual dysfunction and conducting clinical trials on its three lead drugs (Ampion™ , Optina™ & Zertane™), announced the significant results from their further analysis of its Optina™ trial on DME .
The Optina™ trial, conducted at St Michael Hospital in Canada, was a phase II, placebo-controlled, double-masked study to evaluate the efficacy and safety of a 12-week treatment with oral Optina™ in adult patients with Diabetic Macular Edema (DME). Three Optina™ doses were studied and administered orally twice daily. Patients were randomized into one of the three Optina™ arms, or placebo. The primary endpoint was change from baseline to week twelve of treatment in retinal thickness as measured by Optical Coherence Tomography (OCT). Secondary endpoints were 1) change from baseline to week twelve in retinal volume and 2) change from baseline to week twelve in Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA).
Ampio Pharmaceuticals, Inc.