Late-breaking trial: Phase 3 data from ANCHOR trial favor Lucentis

Carmen A. Puliafito, MD, MBA, updated attendees on newly released age-related macular degeneration trial data.

WAILEA, Hawaii — Injection of ranibizumab maintained visual acuity at 1 year better than treatment with photodynamic therapy in patients with wet age-related macular degeneration, according to interim results of a phase 3 trial. The results of the trial, comparing Lucentis (ranibizumab, Novartis/Genentech) with Visudyne (verteporfin for injection, Novartis/QLT) photodynamic therapy in the treatment of wet AMD, showed that ranibizumab offers patients with AMD the best chance for visual improvement, according to a speaker here.

Carmen A. Puliafito, MD, MBA, called the 1-year follow-up data from the ANCHOR (Anti-VEGF Antibody for the Treatment of Predominantly Classic Choroidal Neovascularization in AMD) trial "extraordinary." Dr. Puliafito presented results of the late-breaking trial here at Retina 2006, held in conjunction with Hawaiian Eye 2006 on the island of Maui. These results were first announced 2 days earlier at the Macula 2006 meeting in New York.

In the first year of the 2-year ANCHOR study, 36% of patients treated with 0.3 mg of Lucentis and 40% of patients treated with 0.5 mg of the drug showed improvement in visual acuity by 15 letters or more, Dr. Puliafito said.

On average, patients treated with 0.3 mg of Lucentis gained 8.5 letters and those treated with 0.5 mg gained 11 letters at 1 year, he said. In contrast, patients treated only with Visudyne PDT lost an average of 9.5 letters after 1 year, according to information from Genentech.

"This is a high-powered level-one prospective trial. The strong evidence is that Lucentis gives your patients the best chance of improved vision," Dr. Puliafito said.

Of 140 patients treated with Lucentis, 44 (31%) treated with 0.3 mg and 54 patients (39%) treated with 0.5 mg achieved a visual acuity of 20/40 or better after 1 year, compared with roughly 3% of those in the Visudyne group, according to the press release.

Adverse events in the Lucentis group included conjunctival hemorrhage, increased IOP, eye pain, vitreous floaters, endophthalmitis and intraocular inflammation; the latter two events occurred in fewer than 1% of patients per group. Of systemic adverse effects, myocardial infarctions occurred at a higher rate in the group treated with 0.5% mg of Lucentis than in the other two study arms.

Dr. Puliafito said he is not concerned about non-ocular events that have been associated with Lucentis use.

"I think the amount of the drug that gets into the system is infinitesimal," he said. "Certainly this is something that people are going to look at, but personally I don't think this means anything. We need to have better information about the pharmacokinetic effects these agents have after intravitreal injection."