Evizon-Visudyne combo well-tolerated for AMD

MONTREAL – Squalamine used in conjunction with verteporfin photodynamic therapy “appears to be safe and well-tolerated,” said Thomas A. Ciulla, MD.

Dr. Ciulla spoke about the interim results of a phase 2 trial of Evizon (squalamine, Genaera) in combination with Visudyne (verteporfin for injection, Novartis/QLT) here at the American Society of Retina Specialists meeting.

The efficacy study included 45 patients who received treatment with Evizon at weeks 1, 2, 4 and 5. At week 3, they underwent PDT. The study design includes Evizon therapy monthly for 5 months, with PDT administered at the investigator’s discretion at weeks 15 and 27, Dr. Ciulla said. Patients were randomized to 10 mg, 20 mg or 40 mg doses of Evizon. Follow-up was through week 29.

Baseline visual acuity ranged from 20/32 to 20/200, and all choroidal neovascular lesion types were included. The mean age of the patients was in the “late 70s,” Dr. Ciulla said.

“About 22% of the lesions in each of the groups was minimally classic,” he said. “A majority of the patients had exudative AMD in the fellow eye – roughly 80% of the patients. This was not by study design. I think basically that many of the investigators realized that there may be some value to randomizing these patients into a study that involves systemic treatment. I suspect that many of these patients in the clinic were recruited in the study preferentially because they had bilateral AMD.”

No serious drug-related systemic adverse events and no drug-related ophthalmic adverse events were noted. The most common adverse events were reactions at the peripheral infusion site. There was one reported case of hyperglycemia, Dr. Ciulla said.