Squalamine with PDT deemed safe, tolerable for AMD in phase 2 trial

FORT LAUDERDALE, Fla. — The angiogenic inhibitor squalamine was found to be safe and well tolerated in conjunction with photodynamic therapy in patients with subfoveal neovascularization, according to results from a phase 2 clinical trial presented here.

“The drug was safe, tolerated and showed a trend toward visual stability and improvement,” Thomas A. Ciulla, MD, told attendees at the Association for Research in Vision and Ophthalmology meeting. While a trend in improved visual acuity was noted, he said that the visual benefit was not statistically significant when compared to visual outcomes with PDT and placebo.

“The trend toward visual improvement was not significant in this small early study. But we expect to see further benefit in a larger multicenter trial,” Dr. Ciulla noted. Phase 3 of the squalamine trial is currently in the planning stages, and study sites are being selected.

Squalamine will be marketed as Evizon by Genaera Corp. in the United States, Dr. Ciulla said.

In the phase 2 trial, 45 patients with subfoveal neovascularization marked by minimally classic, predominately classic or occult lesions were enrolled. Patients were randomized to either squalamine injections of 10 mg, 20 mg or 40 mg concomitant with Visudyne (verteporfin photodynamic therapy, Novartis) or verteporfin PDT and placebo.

“Patients randomized to squalamine and PDT tended to have stable visual acuity over time and shared an average gain of 1.3 lines of visual acuity,” Dr. Ciulla said. Patients who received PDT and placebo tended to have decreased visual acuity, with an average line loss of 1 line.