Genentech, Inc has submitted a biologics license application (BLA) to the US Food and Drug Administration for the use of Lucentis (ranibizumab) in the treatment of neovascular wet age-related macular degeneration (AMD).
Lucentis is the first therapy for wet AMD to have shown improved vision in two pivotal phase III trials and demonstrated a clinical benefit over verteporfin (Visudyne) photodynamic therapy (PDT) in a head-to-head clinical trial. As part of the Lucentis BLA submission, 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.
The BLA submission is based on one-year clinical data on the efficacy and safety of Lucentis from two pivotal phase III trials, Anchor and Marina, as well as one-year clinical data from the Phase I/II Focus 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. We look forward to working with the FDA in our efforts to bring this potential therapy to patients quickly as it may offer benefit to patients with all types of wet AMD," said Hal Barron, Genentech's senior vice president of Development and chief medical officer.
AMD is a major cause of painless central visual loss and is the leading cause of blindness for people over the age of 60. The National Eye Institute estimates that there are 1.6 million people with AMD in the United States alone and that this prevalence will grow to 2.95 million by 2020. AMD occurs in two forms: dry and wet.
Lucentis (ranibizumab) is a humanised therapeutic antibody fragment developed at Genentech and designed to bind and inhibit VEGF-A, a protein that is believed to play a critical role in angiogenesis (the formation of new blood vessels). Lucentis is designed to block new blood vessel growth and leakiness, which lead to wet AMD disease progression and vision loss.
Lucentis is being developed by Genentech and the Novartis Ophthalmics Business Unit. Genentech retains commercial rights for Lucentis in North America.
Genentech is a leader in research and product development in the area of angiogenesis, the process by which new blood vessels are formed.