FDA Approves Lucentis for Neovascular (Wet) Age-Related Macular Degeneration

The FDA on Friday approved Lucentis (ranibizumab) for the treatment of neovascular (wet) age-related macular degeneration.

In clinical trials, nearly 95 percent of patients who received monthly intravitreal injections of ranibizumab maintained their vision at twelve months, compared with 60 percent of patients who received sham injections. Adverse events included conjunctival hemorrhage, eye pain, floaters, and increased intraocular pressure, and inflammation.

The drug has sparked controversy, the New York Times reports, because doctors have been using Avastin (bevacizumab) off-label to treat wet AMD and some say it works just as well. (Both drugs are made by Genentech; both inhibit the growth of blood vessels, which leak and damage the retina in wet AMD.) Avastin costs as little as $17 per monthly injection while Lucentis will cost $1,950 per injection, according to the Wall Street Journal.