Genentech, Inc. plans to file a complete Biologics License Application (BLA) for the investigational drug Lucentis (ranibizumab) in December 2005. In addition, the company is in discussion with the US FDA regarding plans to initiate a Phase IIIb clinical study of Lucentis for patients with wet age-related macular degeneration (AMD). The study is anticipated to begin before the end of 2005.
One-year Phase III data from the MARINA study presented at the annual meeting of the American Society of Retina Specialists in July showed Lucentis improved vision in patients with wet AMD. "We recognize the significant unmet medical needs of those with wet AMD and hope to make Lucentis available to patients by seeking FDA approval as quickly as possible," Hal Barron, Genentech senior vice president, development and chief medical officer said adding, "We are encouraged by the magnitude of the benefit observed in the one-year Lucentis MARINA data and are excited about this new Phase IIIb trial, which will help provide more information about the safety profile of Lucentis and the treatment regimen for this chronic disease."
The Phase IIIb SAILOR (Safety Assessment of Intravitreal Lucentis for AMD) study is being designed to evaluate the safety of two different doses (0.3 mg and 0.5 mg) of Lucentis in a broad wet AMD population. The study will be conducted at more than 100 sites in the United States and enrol approximately 5,000 patients.
Meanwhile, the US FDA did not grant Genentech's request for fast-track designation, which allows for a rolling BLA submission.
Genentech and Novartis Pharma AG are conducting an additional Phase III study of Lucentis, ANCHOR (Anti-VEGF Antibody for the Treatment of Predominantly Classic CHORoidal Neovascularization in AMD). This is a randomized, multi-centre, double-masked, active treatment controlled study comparing two different doses of Lucentis to PDT in 423 patients. The trial is ongoing in the United States, Europe and Australia in patients with predominantly classic wet AMD. Results from this study are expected in the fourth quarter of 2005.
Lucentis (ranibizumab) is a humanized 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.