Posted on 08/27/2004 10:37:15 PM PDT by neverdem
Eyetech Pharmaceuticals' drug to treat the leading cause of blindness in the elderly appeared to move closer to a broad government approval yesterday after an advisory panel to the Food and Drug Administration spoke favorably about it.
The advisory panel was not asked to vote on whether the drug, Macugen, should be approved as a treatment for age-related macular degeneration.
But committee members ruled unanimously that Eyetech had provided the F.D.A. with enough information to evaluate the drug. The panel members also did not seem to raise any serious new issues that would block approval.
"It appears to me very efficacious and safe,'' Jose S. Pulido, a panel member and an ophthalmologist at the Mayo Clinic, said during the meeting, held in Rockville, Md.
The F.D.A. is scheduled to make a decision on the drug by mid-December. Pfizer plans to sell the drug in partnership with Eyetech, a New York biotechnology company.
Macugen is directed at the so-called wet form of macular degeneration, which is characterized by a proliferation of blood vessels in the back of the eye that leak and damage the retina, gradually destroying the ability to read, drive or recognize faces. An estimated 1.6 million Americans have the condition and 200,000 new cases are diagnosed each year. Macugen blocks the action of a protein that spurs blood vessel formation and leakiness.
Jennifer D. Harris, the lead reviewer of the drug for the F.D.A., told the advisory panel that the drug "does reduce the risk of vision loss.'' But she said there was no "clinically meaningful" improvement in vision.
The biggest concern of the F.D.A. and of the panel members was that 2 percent of patients in the clinical trials developed potentially serious eye infections. That is because Macugen is given by an injection directly into the eye every six weeks. But panel members said that better monitoring and education of doctors and patients could reduce that risk. Also, after more sterile procedures were adopted during the trials, the incidence of infection dropped.
Some members said more study might be needed of the effects of taking the drug long term because the protein blocked by the drug, vascular endothelial growth factor, has positive effects, like spurring growth of valuable blood vessels in the body.
Only one drug has been approved for wet macular degeneration, Visudyne, which is made by QLT of Vancouver, British Columbia, and sold by Novartis. It is approved for one of three subtypes of the disease.
Eyetech and Pfizer said Macugen worked for all subtypes. The F.D.A. and the panel did not discuss whether approval should be restricted to certain subtypes. That suggested that Eyetech and Pfizer would get a broad approval.
Shares of Eyetech, which were halted during the panel meeting, fell $1.74, to $37.46, after the meeting ended. The stock rose $3.92 on Thursday, when the F.D.A. staff analysis of the drug was made public.
Shares of QLT, which also rose Thursday, fell $1.45, to $16.07.
ping
"That is because Macugen is given by an injection directly into the eye every six weeks"
OUCH ouch ouch!!!
They have topical anesthetics as eyedrops. No whining is necessary.
I've got a phobia about stuff near my eyes. I think I'd need some sort of "calming medication" in order to sit still while they did that. eeeeeewwwwwwwwwwwwww NEEDLE IN MY EYE!!!
Eventually you get used to it...lol
Thanks for the ping!
damn, my mother in law was nearly blind because of this. I take the little test every two or three months, with that grid thing, it is very scary to me. But the shots in the eye,,,weeee,,that is really scary. Visual loss is the most frightening thing. Thanks for the ping.
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