Positive results for Ampio Pharma's Optina in diabetic macular edema

Colorado, USA-based biopharma firm Ampio Pharmaceuticals (NYSE: AMPE) today released positive results of the OptimEyes trial for diabetic macular edema (DME) of Optina, an orally administered ultra low dose of danazol.

The OptimEyes trial was a multiple site, randomized, placebo controlled, parallel, double masked study to evaluate the safety and efficacy of two doses of oral Optina (adjusted to body mass index-BMI) in adult patients with DME.

The OptimEyes trial, with FDA guidance, was designed to include a wide variety of DME patients, some of whom had no therapeutic options and were progressing to blindness. Intraocular injections may have been contraindicated in these patients (eg, patients with glaucoma, prior vitrectomy etc...and were included in the trials). Including patients not accepted in other trials of intraocular injections allowed for better understanding of the effect of oral Optina in improving visual acuity (measured as best corrected visual acuity-BCVA, eye chart) and reducing edema (as measured by optical coherence tomography-OCT) in all patients.