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Lucentis improves vision in patients with wet AMD: study
Montreal | Wednesday, July 20, 2005, 08:00 Hrs  [IST]

Genentech, Inc. has announced positive results from the Phase III MARINA study of the investigational anti-VEGF drug Lucentis (ranibizumab) in 716 patients with wet age-related macular degeneration (AMD).

In addition to meeting the study’s 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 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. One-year data from the study were presented during the 23rd Annual Meeting of the American Society of Retina Specialists (ASRS) in Montreal, Canada, according to a company release.

"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 W. Miller, retina specialist at the Massachusetts Eye and Ear Infirmary who presented the data today.

"We are very excited that Lucentis has improved vision in patients with wet AMD and look forward to results of a second Phase III trial," Hal Barron, Genentech senior vice president, development and chief medical officer said adding, "The magnitude of the treatment effect in this study suggests that Lucentis could have a major impact on the lives of patients with wet AMD."

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).

Lucentis is being developed by Genentech and the Novartis Ophthalmics Business Unit. Genentech retains commercial rights for Lucentis in North America (United States, Canada and Mexico). Novartis has exclusive commercialization rights for the rest of the world.

AMD is a major cause of painless central visual loss and is the leading cause of blindness for people over the age of 60 in the United States and Canada.

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