Posted on 08/29/2004 3:24:27 PM PDT by Ernest_at_the_Beach
WASHINGTON (AP) - A drug that attacks a major form of elderly blindness passed a key hurdle Friday as the government's scientific advisers decided that it poses no significant risks.
Advisers to the Food and Drug Administration did not vote formally whether Eyetech Pharmaceuticals' drug, Macugen, should be approved, but eye doctors on the panel said they were impressed by the research.
The FDA will consider those opinions as it evaluates the product.
Macugen is aimed at treating one type of age-related macular degeneration, the leading cause of blindness among older Americans. The disease steals sight from the center of the eye outward by destroying the macula, light-sensitive tissue in the center of the retina.
Macugen is for the "wet" type of AMD, in which new blood vessels form behind the retina, then leak and rapidly destroy sight. It afflicts an estimated 1.6 million older Americans.
As baby boomers gray, often outliving their eyes, an estimated 6.3 million are expected to suffer from wet macular degeneration by 2030.
Only one treatment currently exists, a light-activated drug that helps destroy abnormal blood vessels.
Macugen works at the molecular level to slow the growth of new blood vessels by blocking an overactive protein.
In a study of 1,186 patients, Macugen or a dummy drug was injected into the eyes every six weeks for 54 weeks.
The drug slowed progressive vision loss, FDA medical officer Jennifer Harris told the advisory committee Friday. Those given a 0.3 milligram dose every six weeks suffered 15 percent less vision loss than untreated patients.
Dashing sufferers' hopes, however, Macugen did not improve eyesight. "There is no clinically meaningful increase in vision," Harris said.
Eighteen patients reported red, swollen, itchy eyes from inflamed tissues within a week of the injection, the company said. Because most of the infections were from common eye organisms, physicians altered the study to lengthen antibiotic use and increase sterility during the procedure.
Research shows the drug so far poses no significant risks, but the drug's label should warn that swelling and itching merit a speedy visit to a doctor, the advisory committee told FDA.
Dr. Wiley Chambers, the agency's vision chief, said the advisers also wanted long-term monitoring of patients in the drug study in case other problems should crop up and specialized tests to safeguard retinal health.
Panel member Jose Pulido, a Mayo Clinic ophthalmologist, said research has raised the possibility of impact elsewhere in the body when the protein that Macugen targets is altered. In the short term, however, Macugen has promise, he said.
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There's a new surgery she's going to ask about but it's expensive and out of pocket.
I'll save this article though and bring it to her next doctor visit.
No doubt the FDA will find a way to delay this product from reaching the people.
Do some internet research on Lutein.........it might help your mom.
I am taken lots of vitamins, including Lutein!
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