Posted on 06/30/2006 8:56:45 PM PDT by neverdem
ASSOCIATED PRESS
WASHINGTON -- The first drug shown to significantly improve the vision of patients threatened by a major cause of blindness in the elderly won federal approval Friday.
The drug, called Lucentis, treats the wet form of age-related macular degeneration, a disorder where blood vessels behind the retina leak blood and fluid, worsening vision and often causing blindness. An estimated 90 percent of the 1.4 million Americans who have lost their eyesight due to the disorder have the wet form.
Lucentis, made by Genentech, Inc., a South San Francisco, Calif., biotechnology company, inhibits the growth of blood vessels when injected into the eye. Other Food and Drug Administration-approved treatments can arrest progression of the disease, which can lead to blindness in just weeks or months, but none has been shown to significantly reverse deteriorating vision.
Genentech may find Lucentis competing against another of its drugs, the cancer treatment Avastin. Avastin is increasingly used to treat macular degeneration for as little as $17 a dose. Lucentis will cost $1,950 per injection, or more than 100 times as much. Each drug is typically injected monthly or bimonthly.
Lucentis and Avastin both block the same protein believed responsible for the blood vessel growth. Early results from Lucentis trials led doctors more than two years ago to begin experimenting with Avastin to treat age-related macular degeneration, commonly called AMD.
"It gave physicians and patients great hope we are going to be able to improve vision in our patients rather than just slow down the loss of vision," Dr. George Williams, an American Academy of Ophthalmology spokesman, said of the early results.
Since then, at least 10,000 macular degeneration patients have received Avastin injections, a so-called "off-label" use of the drug.
"It's become a worldwide phenomenon," said Dr. Philip Rosenfeld, a professor of ophthalmology at the Bascom Palmer Eye Institute in Miami, who pioneered its use for AMD.
The FDA does not sanction using Avastin to treat macular degeneration. Genentech stresses that it has not studied the safety or effectiveness of Avastin in treating the disease, nor does it plan to do so.
"We believe Lucentis is a much better choice," said Dr. Hal Barron, Genentech's chief medical officer. "I really believe when treating patients, you have to look at the wealth of data supporting its use and the quality of that data."
The National Eye Institute, part of the National Institutes of Health, has received an outside proposal to conduct a study comparing Avastin and Lucentis in treating AMD, said the government institute's Dr. Maryann Redford.
Genentech engineered Lucentis to better penetrate the retina while reducing inflammation, Barron said. Lucentis also clears the body faster than Avastin, and better targets the protein important to vessel formation, he added.
Still, the anticipated cost of Lucentis may constrain its use, since Avastin is far cheaper when vials of the cancer drug are divvied up and used to treat macular degeneration.
"The bottom line is, wherever price does matter, Avastin will probably be used as first-line therapy. But wherever price is not an issue, like in Medicare patients and Medicaid patients, Lucentis will be used," Rosenfeld said.
Neither drug is a cure for age-related macular degeneration. Lucentis is most effective when injected monthly, said Dr. Wiley Chambers, deputy director of the FDA's Division of Anti-infective and Opthalmologic Products. The disease is named for the macula, the central portion of the retina responsible for detailed central vision.
The two other FDA-approved therapies to treat macular degeneration are Novartis AG/QLT Inc.'s Visudyne, which combines a light-sensitive drug and laser therapy to seal leaking blood vessels, and OSI Pharmaceuticals Inc./Pfizer Inc.'s Macugen, which is injected into the eye. Both slow the progression of the disorder but typically reverse its effects in only 5 percent to 10 percent of patients, Chambers said.
Lucentis' most commonly reported side effects include conjunctival hemorrhage, eye pain, floaters, increased eye pressure and inflammation.
In clinical trials, nearly 95 percent of participants given monthly injections maintained their vision at one year, compared with the approximately 60 percent who did after receiving another treatment, the FDA said. Approximately one-third of the Lucentis patients also reported improved vision after a year.
Genentech said it would start shipping Lucentis on Friday.
On the Net:
Food and Drug Administration: http://www.fda.gov/
Genentech Inc.: http://www.gene.com/
Good for her!!!
Wish they had had this for my Mom. She went through that procedure where they inject a gas bubble and had her keep her face down for weeks. A lot of nothing is what she got from that.
I don't know if a British paper can be posted here so this is the teaser and a link.
Better results for 1 (one) percent of the cost of Lucentis. Read the article ... really shows where the drug companies hearts are... if they had one.
"A major drug company is blocking access to a medicine that is cheaply and effectively saving thousands of people from going blind because it wants to launch a more expensive product on the market.
Ophthalmologists around the world, on their own initiative, are injecting tiny quantities of a colon cancer drug called Avastin into the eyes of patients with wet macular degeneration, a common condition of older age that can lead to severely impaired eyesight and blindness. They report remarkable success at very low cost because one phial can be split and used for dozens of patients." article
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Let's Move Medicine Into the Information Age This comment was about one of the more satisfying disgnoses I helped to make, but it also shows how complete electronic medical records can help when patients can't give their medical history. I tried to write in plain English, not in medicalese.
FReepmail me if you want on or off my health and science ping list.
Thanks.
Will get this off to my dad ASAP. He's afflicted with the dread disease. Tends to have to leave his fun Caddy Escalade parked nowadays unless his step-daughter drives him in it.
That says a lot about why health care costs are going up so fast in this country.
I had an elderly friend with macular degeneration. He loved to read. For a while he was able to use special magnifying devices but eventually even these couldn't help him.
for later reading
My tarheel dad is getting this treatment in Asheville and it appears to have stopped the degeneration and perhaps is even reversing some of it.
Avastin injection brought back 80-85% of my left eye's vision. A miracle drug IMO.
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If there are good drugs out there that will cure or help; they should be available and affordable to the public.
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