Second Lucentis trial shows 95% of AMD patients improved or maintained vision

BASEL, Switzerland — In a second phase 3 trial, 95% of patients taking ranibizumab for the treatment of wet age-related macular degeneration either maintained or improved vision for 1 year, according to the drug’s developers.

One-year results of the 2-year study show that 94% of patients treated with Lucentis (ranibizumab, Novartis/Genentech) 0.3 mg and 96% of patients treated with Lucentis 0.5 mg maintained vision or improved vision. In comparison, 64% of those treated with Visudyne (verteporfin for injection, Novartis/QLT) in the trial maintained or improved vision at 1 year. Study data will continue to be analyzed through a second year, according to a press release from Novartis.

The ANCHOR (Anti-VEGF Antibody for the Treatment of Predominantly Classic Choroidal Neovascularization in AMD) study is a phase 3, randomized, multicenter, double-masked, active-treatment controlled trial comparing two doses of Lucentis to photodynamic therapy in patients with predominantly classic wet AMD.

Of 423 patients with 1 year follow-up in the trial, 140 were treated with 0.3 mg of Lucentis, 140 were treated with 0.5 mg of Lucentis and 143 received Visudyne therapy. “Maintaining vision” was defined in the study as a loss of less than 15 letters in visual acuity. Participants in the Lucentis arms of the trial were treated monthly; those in the Visudyne arm were treated every 3 months.

Patients treated with Lucentis had a “significant improvement in visual acuity compared to their visual acuity at study entry,” a secondary endpoint of the trial, according to the press release. Preliminary safety findings were consistent with those observed in another phase 3 pivotal study.

Novartis said results from these two pivotal trials will be used to file for regulatory approval.

Genentech, the co-developer of Lucentis along with Novartis Ophthalmics, retains marketing rights to the drug North America; Novartis has exclusive marketing rights outside North America.

“The outstanding results of this second phase 3 study demonstrate Lucentis’ potential to improve vision in patients with all types of wet AMD,” said Nicholas Franco, president of Novartis Ophthalmics. “With Lucentis, we hope to be the only pharmaceutical company to provide wet AMD patients with two effective treatments, Lucentis and Visudyne, with different and potentially complementary modes of action.”

Ocular adverse side effects that occurred more frequently in the Lucentis arms than in the control group were mild or moderate, and included conjunctival hemorrhage, eye pain, increased IOP and vitreous floaters, the press release said. Serious ocular adverse events that occurred more frequently in patients treated with Lucentis included endophthalmitis (1%). The frequency of myocardial infarction was slightly higher in patients dosed with Lucentis 0.5 mg compared with the other two arms, but the difference was not statistically significant, the release said.