Lucentis has been hailed as a breakthrough in the treatment of "wet" macular degeneration because it is the first drug approved by the Food and Drug Administration which may improve vision in some patients. In the "wet" form of AMD, abnormal blood vessels grow and as they leak or hemorrhage may rapidly destroy central vision. Before Lucentis and the previously approved Macugen, "wet" AMD was treated with lasers that stopped the bleeding but could not improve vision.
Genentech Inc., the San Francisco-based biotech company, which invented Lucentis also produces Avastin, a drug which has been approved for the treatment of colon cancer. Similarly to Lucentis, Avastin has been used to treat macular degeneration by blocking abnormal blood vessels. The drugs have to be used early on, and they have to be used often. Lucentis and Avastin are injected directly into the vitreous (the gel-like filling inside the eye), but there is a significant price differential as Lucentis costs $2000 per injection and Avastin about $50 per dose. That adds up to some $48,000 for the recommended two years of Lucentis treatment. Avastin is not FDA approved for ophthalmic use. Nevertheless retinal specialists claim to have gotten good results from Avastin and continue to use it. Medicare will cover Lucentis injections as in-office procedures, but unless a person carries secondary insurance the co-payment may be $400 per treatment. Medicare doesn’t cover treatments with Avastin because it doesn’t have Federal approval for AMD.
Compared to Macugen, which stabilizes vision in approximately 65% of people, with about 6% making gains, Lucentis stabilizes vision for an estimated 95% of patients and improves it for about 40%. Although Lucentis has a better success rate, its side effects can include stroke and heart attack. Since Avastin has not been tested in macular degeneration clinical trials, doctors don’t know if it is as effective as Lucentis. Lucentis was formulated specifically for use in the eye, and also leaves the body faster than Avastin. Genentech offers a free drug program for people who lack insurance. "No patient should go without one of our therapies because of lack of finances," according to company spokeswoman Dawn Kalmar.
The ANCHOR study compared two different doses of Lucentis (0.3 mg and 0.5 mg) versus Photodynamic Therapy (PDT) in 423 patients with wet AMD. One-year results showed that approximately 31% treated with 0.3 mg of Lucentis and nearly 39% of patients treated with 0.5 mg of Lucentis achieved a visual acuity of 20/40 or better compared to 3% of those treated with PDT. Lucentis, a biologic product, was shown to be safe and clinically effective in three multi-center, randomized studies of patients who were representative of the population usually affected with AMD. In clinical trials, nearly 95% of the participants who received a monthly injection maintained their vision at 12 months compared to approximately 60% of patients who received the control treatment. Approximately one-third of patients in these trials had improved vision at 12 months. In a single study carried out for 24 months, these findings have been maintained with continued monthly dosing. The most commonly reported adverse events included conjunctival hemorrhage, eye pain, floaters, increased eye pressure and inflammation of the eye.
Because of the large price differential, some doctors continue to use Avastin. "Sometimes, it does end up being a money issue if the co-pay becomes an issue," says Dr. Arman Farr of Charlotte’s Retina Institute of the Carolinas and the Macular Degeneration Center. "As big a problem as this is, looking at our bankrupt health system, if you can save 90% on your drug cost and it is just as good, you can understand why doctors use it," Farr says.
For all questions related to Lucentis, please call the Lucentis Commitment Hotline at 1-866-724-9394 or visit the Lucentis Web Site.
- FDA News, June 30, 2006
- Pam Kelly, Cancer Drug May Fill in For Lucentis, September 17, 2006, Doctors Debate Macular Degeneration Treatments, September 22, 2006, McClatchy Newspapers.
- Karen Shideler, Pair of Drugs Help Save Eyesight, The Wichita Eagle, September 19, 2006.