Approximately 94% of patients treated with 0.3mg of Lucentis and 96% of those treated with 0.5mg of the drug maintained or improved vision, compared to approximately 64% of those treated with Visudyne photodynamic therapy during the first year of the two-year study.
Genentech plans to submit a marketing application for Lucentis in December 2005, and will also ask for priority review designation for the drug at that time.
“Lucentis is the first potential therapy for wet age-related macular degeneration to improve vision in two pivotal phase III trials and demonstrate a clinical benefit over PDT in a head-to-head study,” said Dr Hal Barron, Genentech’s chief medical officer. “Based on these compelling results and current unmet medical need, all patients in the study will have access to Lucentis during the remainder of the trial.”