Squalamine stabilized vision in AMD in interim phase 2 results

PLYMOUTH MEETING, Pa. — A 40 mg dose of squalamine was “safe and well tolerated and stabilized vision” in eyes with age-related macular degeneration, according to interim results of a phase 2 trial announced by the drug’s developer.

Evizon (squalamine lactate, Genaera Corp.) improved or stabilized vision in 83% of patients who received the 40 mg dose, compared with 71% of patients in a control group.

“This effect was significantly more pronounced in subjects who did not receive photodynamic therapy with verteporfin,” the release said.

Full interim data was analyzed for 108 subjects, the release noted. The average age of the subjects was 75, and nearly half the subjects had active occult disease. About 60% had a fellow eye that was affected.

Evizon is administered intravenously once a week for the first 4 weeks, and then monthly. In the 40 mg group, 5% of 42 patients had a gain in visual acuity of 15 letters or more; 4% of 45 patients in the 20 mg group experienced the same gain in letters. No patients in the control group had an improvement in vision.

Genaera said it plans to initiate a second phase 2 study to explore doses of the drug up to 160 mg.