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Evizon, PDT combination well tolerated

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PLYMOUTH MEETING, Pa. — A combination of two treatments for age-related macular degeneration demonstrated safety when administered concomitantly, according to results of an exploratory clinical trial.

A phase 2 trial of Evizon (squalamine lactate, Genaera) plus photodynamic therapy with Visudyne (verteporfin for injection, QLT/Novartis) met its primary end point of demonstrating safety when the two treatments are administered concomitantly, according to a press release from Genaera. No serious drug-related adverse events have been reported in the trial to date, the press release said.

Preliminary analyses indicated that subjects treated with 40 mg of Evizon plus Visudyne PDT at 29 weeks had a “slight increase in mean visual acuity compared with visual acuity at study entry,” which was a secondary endpoint of the trial, according to the Genaera press release. A group of subjects receiving PDT alone had a mean decrease in VA from baseline to 29 weeks. About 90% of those enrolled in the trial maintained vision, the press release said. Maintaining vision was defined as a gain or loss of fewer than 15 letters.

Ten percent of the patients treated with 40 mg of Evizon and PDT required a second PDT treatment. For those in the PDT-only group, 47% required a second PDT treatment.

“Overall, our data have been consistent with the use of intravenous Evizon as an ongoing therapy to maintain or improve vision in one or both affected eyes as opposed to the chronic injections into each affected eye required for the administration of other approved or investigational anti-angiogenic agents,” said Roy C. Levitt, MD, president and chief executive officer of Genaera, in the press release.

The phase 2 trial is designed to evaluate in 45 subjects with wet AMD the safety and clinical effects of three doses of systemically administered Evizon (10 mg, 20 mg and 40 mg) along with initial concomitant PDT treatment in 10 patients per Evizon dose, and to compare these results with those in 15 control subjects receiving PDT alone.

Preliminary results from this trial will be presented at the American Academy of Ophthalmology meeting in Chicago, according to Genaera.