Genaera's study shows Evizon may benefit patients with wet AMD and deteriorated vision

By Lisa Kerner

Erie, Pa., March 29 - Genaera Corp. said a new subset analysis of Evizon (squalamine lactate) clinical data suggests the treatment may benefit patients with wet age-related macular degeneration (AMD) whose vision has already significantly deteriorated.

The data was presented at the IBC Third Annual Ocular Anti-angiogenesis Conference in Cambridge, Mass., according to a company news release.

In an overview of phase 2 clinical trial data, Genaera's senior vice president of clinical research and development, Michael J. Gast, described outcomes for subjects in the studies with fellow affected eyes (documented disease in the second eye) and poor vision at study entry.

"These data, which are consistent across our phase 1/2 program, suggest that intravenous Evizon safely stabilizes or improves vision in both the study eye and the fellow affected eye in a dose responsive fashion," Gast said in the release.

"What is particularly intriguing is that this effect appears to be most marked in subjects with poorer vision in fellow affected eyes, many of whom, as a result of their low visual acuity, would not currently be considered good candidates for treatment. We look forward to confirming this benefit in ongoing studies."

In Study 207, an 18-patient, multicenter, open-label pharmacokinetic trial, mean best corrected visual acuity in fellow affected eyes across all Evizon dose groups improved over baseline by as many as eight letters following four weekly treatments with Evizon in subjects with poorer vision, the company said.

A similar effect was seen in the larger Study 209, where a dose response across Evizon treatment groups was evident. An analysis of all fellow affected eyes at 24 weeks showed that the 40 mg Evizon dose improved vision by four letters on average from baseline and the 20 mg dose improved vision by approximately two letters. The placebo group declined from baseline by an average of three letters.

Additionally, Genaera's Study 212, a 16-week, multicenter, randomized, open-label, pharmacodynamic and safety study, is designed to determine if higher dose levels of Evizon will produce greater improvements in visual acuity. This study, slated to begin in the second quarter, will evaluate four intravenous doses of Evizon (40 mg, 80 mg, 120 mg and 160 mg).

Genaera is a biopharmaceutical company located in Plymouth Meeting, Pa.

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