LUCENTIS IMPROVES VISION IN PATIENTS WITH MACULAR DEGENERATION

Genentech has announced positive results from the Phase III MARINA study of the investigational anti-VEGF drug Lucentis in patients with wet age-related macular degeneration (AMD). There was a 17 letter difference in mean change in visual acuity from study entry between patients treated with Lucentis (regardless of 0.3 mg or 0.5 mg dose) and those in the control group, as measured by the Early Treatment of Diabetic Retinopathy (ETDRS) eye chart. 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.

An analysis of the one-year data showed that adverse events were similar to those seen in earlier trials of Lucentis. Common side effects occurring more frequently in the Lucentis arms than in the control group were mild to moderate and included conjunctival hemorrhage, eye pain and vitreous floaters. Serious ocular adverse events occurring more frequently in Lucentis-treated patients were uncommon 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). Earlier this month, Genentech announced it has requested a fast-track designation for the Lucentis development program in wet AMD.