As part of the application, Genentech has requested a priority review designation from the FDA, which, if granted, would give the FDA six months from the agency’s receipt of the submission to take action on the application.
Lucentis produced improved vision in two pivotal phase III trials and demonstrated a clinical benefit over Visudyne, made by QLT and co-marketed by Novartis, in a head-to-head clinical trial.
The submission is based on one-year clinical data on the efficacy and safety of Lucentis from two pivotal phase III trials, as well as one-year clinical data from a phase I/II trial.
In addition to these registrational studies, Genentech is currently enrolling patients with wet AMD in a phase IIIb safety study called “Sailor”. Data from the phase IIIb “Pier” study evaluating a less frequent dosing regimen for Lucentis are anticipated in the first half of 2006.
“This application represents a summary of data from more than six years of rigorous clinical study and the dedication of thousands of patients and physicians hoping to improve outcomes for those with this devastating disease,” said Dr Hal Barron, Genentech’s chief medical officer.