Genentech files for FDA review of eye drug

SOUTH SAN FRANCISCO, Calif., Dec. 30 (UPI) -- Genentech said Friday it has filed for approval of Lucentis to treat age- related macular degeneration.

The company said it has submitted a biologics license application to the Food and Drug Administration for the use of Lucentis in the treatment of neovascular wet age-related macular degeneration, which Genentech said is the first treatment for wet AMD to have shown improved vision in patients enrolled in two Phase 3 studies.

The firm said its potential eye therapy also showed a clinical benefit over Visudyne photodynamic therapy in a comparative trial.

Genentech said it has asked the FDA for priority review for its drug, which means the agency would either approve or reject the application within six months.

The company said it submitted to the FDA one-year data on the efficacy and safety of Lucentis from two Phase 3 trials, and one-year data from a third Phase I/II trial. In addition, Genentech said it is enrolling patients with wet AMD in a Phase IIIb safety study called "SAILOR," while data from the Phase IIIb "PIER" study evaluating a less frequent dosing regimen for Lucentis are expected in the first half of 2006, the company said.