Ampio reports positive results in DME patients treated with Optina

Ampio Pharmaceuticals reported positive results in the phase 3 OptimEyes trial in patients with diabetic macular edema, according to a press release.

The multiple site, randomized, placebo-controlled, parallel, double-masked study evaluated the safety and efficacy of two doses of Optina (danazol) in adult patients with DME. Dosage was based on patient’s body mass index, the release said.

The goal of the study was to assess the safety and efficacy of Optina and identify patients who respond and the ideal dosage. Orally administered Optina was considered safe with no drug-related adverse events, the release said.

In a subgroup analysis, 53% of patients who did not respond to approved intraocular injection therapies showed a visual acuity improvement of 6.2 letters over a 3-month period (P < .001), and 47% of patients who were unable or unwilling to have intraocular injection therapies showed an improvement of 3.1 letters (P = .04). The placebo did not achieve a significant improvement in visual acuity.

Furthermore, patients in the subgroup who were treated with Optina showed a decrease of 46 µm in retinal swelling (P = .003). The placebo group did not show a significant change in retinal swelling, the release said.

The company plans to continue the analysis and present its data to the FDA.