Genentech will no doubt be celebrating after Phase III clinical trial data reinforced the efficacy of its Lucentis (ranibizumab) drug for the treatment of wet age-related macular degeneration – a leading form of blindness.
The study, which included 716 patients with wet AMD, met its primary efficacy endpoint of maintaining vision in patients with wet AMD. Secondary endpoint results show there was a 17-letter difference in mean change in visual acuity from study entry between patients receiving Lucentis and those in the control group – at 12 months, patients treated with Lucentis gained an average of seven letters in visual acuity compared to study entry, while those in the control group lost an average of 10.5 letters.
"These data are very compelling because, for the first time, we have a potential treatment which has been shown to improve vision in a significant number of patients with wet AMD as opposed to just slowing progression of vision loss," said Joan Miller, retina specialist at the Massachusetts Eye and Ear Infirmary.
Genentech and Novartis are conducting an additional Phase III study of Lucentis, known as Anchor, which is comparing two different doses of Lucentis with photodynamic therapy in 423 patients with predominantly classic wet AMD. Results from this study are expected in the fourth quarter of 2005.