Eye Drug Lucentis Shows Vision Benefits
Eye Vision Drug Trial
Drugmaker Novartis AG (NVS) said Wednesday that its eye drug Lucentis maintains or improves vision in patients with age-related macular degeneration, the leading cause of blindness in elderly people.
Novartis, based in Basel, Switzerland, said two late-stage studies, which involved 1,139 people suffering from wet, age-related macular degeneration, a form of bleeding behind the retina, were published in the New England Journal of Medicine. The studies demonstrate that treatment with Lucentis, or ranibizumab, maintains or improves vision in patients with wet-form AMD, Novartis said.
Results from both studies had been presented earlier, but publication in a prestigious medical journal is seen as validation of the significance of the results.
Lucentis is approved in Switzerland and the U.S. for treatment of wet AMD. Novartis submitted the drug for European Union approval in March and expects a decision in the first half of 2007.
AMD is an eye disease characterized by abnormal, leaky blood vessels that form under the retina, the light-sensing part of the eye. The vessels leak fluid into the eye, damaging the macula, the central part of the retina at the back of the eye. The macula is responsible for the straight-ahead vision necessary for everyday activities like reading, driving, watching television and identifying faces.
Lucentis is the first drug ever that has been shown to improve vision in people suffering from wet-form AMD.
The drug was developed by Novartis and Genentech Inc. (DNA), a U.S. biotechnology company which is selling Lucentis in the U.S. Novartis owns the marketing rights for the rest of the world.
Genentech has been criticized by some for the high price it is charging for Lucentis, which is derived from the same mouse antibody from which its successful cancer drug, Avastin, was developed. Lucentis costs around 100 times more a dose than Avastin.
Before Lucentis had won U.S. approval, some doctors had treated the eye condition with Avastin, in what is known as off-label use. Avastin is approved only to treat cancer, but when used for the eye condition it works the same way as Lucentis. What's missing, however, is solid data from clinical trials on the safety and efficacy of Avastin when used to treat the eye disease.