Systemic Evizon for AMD safe, surgeon says

MONTREAL — An intravenous anti-angiogenic drug for the treatment of age-related macular degeneration has a strong safety profile, according to results from a small phase 2 study, said Brian P. Connolly, MD.

Evizon (squalamine, Genaera) is selectively absorbed by activated endothelial cells, he said.

“It acts by inhibiting VEGF as well as several other growth factors,” Dr. Connolly said here at the American Society of Retina Specialists meeting.

A total of 18 patients were enrolled in a phase 2 study and divided into three groups: 10-mg, 20-mg and 40-mg treatments, dosed for 4 weeks and then followed for 4 months. Primary endpoints were the safety and pharmacokinetic profile of the drug, with secondary endpoints being visual acuity, optical coherence tomography, angiography and fundus photos, he said. Enrolled subjects had to be older than 50 years and had to have confirmed subfoveal choroidal neovascularization; fibrosis could not account for more than 25% of the lesion area, and subretinal blood could not account for more than 50% of the lesion area. Baseline visual acuity ranged from 20/32 to 20/200 in the study eye, Dr. Connolly said.

“In addition, 17 of the 18 patients had choroidal neovascularization in the fellow eye,” he said.

There were no drug-related serious adverse events and no drug-related ophthalmic adverse events, he said. The most common adverse event was peripheral infusion site reactions, “and most of the adverse events were mild to moderate in nature,” he said.

In short, he said, squalamine has a “rapid systemic clearance with intravenous infusion.” The 40-mg dose “preserved or improved vision in all patients through 4 months, and the preliminary evidence shows the 40- and 20-mg doses appear better than the 10-mg dose,” Dr. Connolly said.

Because the drug is systemic instead of intravitreal, there was a bilateral response in both early and late lesions, he said.