Bert Harbin, 75, can sum up his vision problem succinctly: "Dark items got darker."
Even after cataract surgery last fall, he found he had trouble picking out dark motorcycles driving next to him on the road and other dark objects at night. Eventually, he went to the Southeast Retina Center, where he ended up on a clinical trial for a drug called Lucentis that was just approved by the Food and Drug Administration to treat the wet form of age-related macular degeneration.
Even with that approval, Mr. Harbin and patients like him are on a one-year trial to gauge not only how often they should receive shots but also to give the manufacturer, Genentech, more long-term data, said Dennis Marcus, whose center has 38 patients receiving Lucentis, one of the larger pools enrolled in the trials. Although the drug was approved June 30, Dr. Marcus said there is good reason to continue the trials.
"The reason is to look at extended safety because companies are interested, especially with Vioxx and all of those post-FDA approval issues, to extend the safety (monitoring), to extend their experience to report further safety (data)," Dr. Marcus said.
The arthritis drug Vioxx was withdrawn by its manufacturer after a study found increased risk of heart attacks and strokes well after the FDA approved it.
Doctors are also still sorting out how to use Lucentis in light of a similar drug called Avastin, which is also made by Genentech but does not have FDA approval. Avastin is a cancer drug that is used "off-label" - or outside approved use - to help treat wet macular degeneration, the leading cause of blindness in the elderly. Both drugs appear to block the action of a substance that can fuel the growth of leaky blood vessels under the retina in the back of the eye, leading to the loss of central vision.
If patients are doing fine on Avastin, which the center also uses, then they might stay on it, Dr. Marcus said. Part of the consideration is financial - Lucentis retails for $1,950 a shot, while Avastin costs about $300 a dose. But Lucentis is likely to be covered by Medicare and other insurers, he said.
"So the question is what will be done in the future now that the government has to be willing, and they are, to cover this very large expense when Avastin may be as good but is not FDA approved and the safety hasn't been as thoroughly tested as Lucentis has," Dr. Marcus said.
The answer is already clear for Dorothy Fortson, 79, who noticed about two years ago that she had a blind spot in her right eye as she read. She underwent the current therapy at the time, then tried another shot before she found relief with Lucentis, said Hiranderjit Singh of the Retina Center.
"This was the one that did the trick," Dr. Singh said.
Being able to read clearly is important for Mrs. Fortson, who has taught a Bible-study class at Memorial Baptist Church in Aiken for 50 years.
"I have to do a lot of studying," she said. But even after all these years, "you always get something different from it."
Reach Tom Corwin at (706) 823-3213 or tom.corwin@augustachronicle.com.
ABOUT LUCENTIS
STATUS: Approved by the Food and Drug Administration
MAKER: Genentech Inc., in San Francisco
HOW IT WORKS: The drug is injected into the eye. It targets vascular endothelial growth factor, or VEGF, which is thought to fuel the abnormal growth of leaky blood vessels through and beneath the retina that causes loss of sight. The drug binds to VEGF to prevent it from stimulating that growth.
COST: Lucentis will cost $1,950 per injection. It is expected that the drug will be covered by Medicare and other insurance.
- From staff and wire reports
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