FDA Approves Lucentis As Treatment For Age-Related Blindness

FDA on Friday approved Genentech’s Lucentis, the first drug proven to restore vision in a significant percentage of people with wet age-related macular degeneration, the San Francisco Chronicle reports (Tansey, San Francisco Chronicle, 7/1). Wet age-related macular degeneration is caused by the abnormal growth of blood vessels behind the eye, which can leak blood and other fluid and create scar tissue that over time destroys the center of the retina. Lucentis inhibits a protein that is believed to assist the formation of the abnormal blood vessels. Two major studies find that 95% of patients with the disease who were treated with Lucentis experienced no decline in vision during one year and that 34% to 40% experienced improved sight. Lucentis is not a treatment for dry age-related macular degeneration, which is more common and less serious than the wet type, the San Jose Mercury News reports (Johnson, San Jose Mercury News, 7/1). Lucentis will cost $1,950 per injection, which is more than 100 times the lowest price for a small dose of Avastin, a similar Genentech drug used by some doctors to treat the disease (Wall Street Journal, 7/1). Avastin is approved to treat cancer, but some doctors since late 2005 have been using the injectable medication to treat wet macular degeneration. Avastin costs about $50,000 per year to treat cancer, but because the amount needed for eye injections is small, the cost for treating wet macular degeneration is about $1,000 or less per year. Both drugs were designed to block vascular endothelial growth factor, which controls abnormal blood vessel growth. Lucentis was designed to be a smaller drug that more effectively penetrates the eye and concentrates its effects, minimizing side effects, according to Susan Desmond-Hellmann, president of product development at Genentech (Kaiser Daily Health Policy Report, 6/29). Lucentis’ FDA-approved label recommends monthly injections, but Genentech said the average patient will receive only five to seven injections in their first year because of the risk of eye pain, inflammation and increased pressure. Genentech said there are about 242,000 U.S. candidates for Lucentis treatment (San Francisco Chronicle, 7/1).

Genentech “emphasiz[ed] that it has not studied the safety or effectiveness of Avastin in treating the disease, nor does it plan to do so,” the AP/Chicago Tribune reports. Genentech’s Chief Medical Officer Hal Barron said, “We believe Lucentis is a much better choice” (Bridges, AP/Chicago Tribune, 7/1). Eugene de Juan, president of the American Society of Retina Specialists and a professor of ophthalmology at the University of California-San Francisco, said, “This is important and a major change in ophthalmology” (San Jose Mercury News, 7/1). De Juan added, “From a retina doctor’s point of view, this is pretty close to penicillin. It’s like reversing aging.” Genentech officials said the company has established programs to provide Lucentis at no cost to uninsured patients and to cover Medicare copayments for qualified applicants. Joshua Schimmer, an analyst for SG Cowen, said Lucentis’ biggest competition would be Avastin. Schimmer estimated the total market for wet macular degeneration treatments at $750 million to $1 billion (San Francisco Chronicle, 7/1). Maryann Redford of NIH’s National Eye Institute said her agency has received an outside proposal to conduct a head-to-head trial comparing Avastin and Lucentis (AP/Chicago Tribune, 7/1).

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View drug information on Avastin; Lucentis.