Phase III trial to compare wet AMD drugs

Tarrytown, NY-Regeneron Pharmaceuticals Inc. and Bayer HealthCare have initiated a phase III study of a fusion protein anti-vascular endothelial growth factor (VEGF Trap-Eye) in the neovascular form of age-related macular degeneration (wet AMD).

The study will compare the agent, administered at 4-and 8-week intervals, and ranibizumab (Lucentis, Genentech), administered at 4-week intervals. About 1,200 patients throughout the United States and Canada will be enrolled in the randomized, double-masked study. Patients will be given 0.5-mg and 2-mg doses at 4-week intervals, and 2 mg at 8-week intervals, compared with 0.5 mg of ranibizumab every 4 weeks.

The study hopes patients' vision will improve or lose fewer than 3 lines on an Early Treatment Diabetic Retinopathy Study chart at the end of 1 year.

In an analysis of interim data from the ongoing phase II trial, in which patients were treated with the agent monthly or quarterly, patients demonstrated a statistically significant reduction in retinal thickness and improvement in visual acuity after 12 weeks, compared with baseline.

Regeneron and Bayer are collaborating on the drug development. Bayer will market the drug outside the United States, while Regeneron maintains rights in the United States.