Othera reports positive interim results from Phase II dry AMD trial

Othera reports positive interim results from Phase II dry AMD trial

Published:13-April-2009

By Datamonitor staff writer

137 patients enrolled at 20 leading retinal disease treatment centers across the US

Othera Pharmaceuticals, a specialty pharmaceutical company, has reported positive interim data from its Phase II trial of OT-551 in treating geographic atrophy, an advanced form of dry age-related macular degeneration for which there is no FDA-approved treatment.

According to Othera, the 12-month findings from the two-year Omega trial suggest an emerging trend for reducing moderate vision loss in patients with geographic atrophy (GA) who were treated with OT-551 compared with placebo. This numeric trend was more pronounced in subgroups based on GA characteristics or level of visual acuity at baseline.

The Omega study is a randomized, double-masked, dose-ranging, multi-center, Phase II study of topical OT-551 in patients with GA associated with age-related macular degeneration (AMD). Approximately 137 patients were enrolled at 20 leading retinal disease treatment centers across the US in this two-year study.

OT-551 has demonstrated a dose-dependent protective effect on photoreceptor activity in an animal model of AMD, and has been shown to reach the back of the eye after topical dosing in multiple species. This profile supports the rationale for studying the drug in patients with degenerative retinal conditions, such as GA, the company said.

Al Reaves, senior vice president of clinical development at Othera, said: "Based on these preliminary results, OT-551 continues to exhibit the excellent safety profile seen in prior studies. Given OT-551's safety profile and the positive trend on visual acuity, continued follow-up of this elderly population with GA should allow us to profile the drug's effect on visual acuity and better understand its long term safety."