Genentech, Inc. has announced that a Phase III clinical study of the investigational drug Lucentis (ranibizumab) met its primary efficacy endpoint of maintaining vision in patients with wet age-related macular degeneration (AMD).
Approximately 95 per cent of patients maintained or improved vision (defined as a loss of less than 15 letters in visual acuity) at one year when treated with Lucentis injections compared to approximately 62 per cent of those treated in the control arm. Patients treated with Lucentis for 12 months had, on average, a significant improvement in visual acuity compared to their visual acuity at study entry, an important secondary endpoint, while the control group demonstrated a substantial decrease in mean visual acuity from baseline to 12 months. One-year data from the trial will be presented at the 23rd Annual Meeting of the American Society of Retina Specialists (ASRS), July 16 to 20 in Montreal, Canada, a company release stated here.
"These Lucentis data exceeded our expectations because they show, for the first time in a Phase III trial, a statistically significant improvement in vision for patients in a disease that has remained chronic and progressive despite current treatment options," said Hal Barron, Genentech senior vice president, development and chief medical officer.
A preliminary analysis of the data showed that adverse events were similar to those seen in earlier trials of Lucentis. Common side effects occurring in the Lucentis arms more frequently than in the control group were mild to moderate and included conjunctival haemorrhage, eye pain and vitreous floaters. Serious ocular adverse events occurring more frequently in Lucentis-treated patients were rare and included uveitis and endophthalmitis. There appeared to be no imbalance in serious non-ocular adverse events.
Lucentis is a humanized antibody fragment developed at Genentech and designed to bind and inhibit Vascular Endothelial Growth Factor A (VEGF-A), a protein that is believed to play a critical role in angiogenesis (the formation of new blood vessels).