October 10, 2002.
By: ANDREW POLLACK,
The New York Times.
Experimental drugs show preliminary signs of improving eyesight in some elderly people who suffer from a disease that causes blindness, scientists said at a conference here today.
The drugs, still in clinical trials, are intended to treat age-related macular degeneration, the leading cause of blindness in the elderly. In a 64-patient trial, 26 percent of the patients treated with one drug, rhuFab V2, had improved vision of at least three lines on an eye chart after three months, doctors reported at Retina Congress 2002. Such a gain can allow people to resume reading or driving, ophthalmologists said.
Over all, the patients had an average gain of almost two lines. Untreated patients lost a line.
Doctors cautioned that the trial was too small to reach firm conclusions. Moreover, the drug, developed by Genentech, the biotechnology company of South San Francisco, Calif., appears to work just in people with newly diagnosed cases of the disease and not people who have had it a long time, doctors said. The effects might not last that long, some experts said, so that vision could deteriorate after three months.
Repeated injections into the eye to maintain the improvement could subject patients to infections.
Still, some ophthalmologists said rhuFab and similar drugs could one day offer hope to people with a disease that is now largely untreatable.
"It's clear that vision can be restored, improved, in a large number of people," said Dr. Carmen A. Puliafito, chairman of the Bascom Palmer Eye Institute at the University of Miami, who presented a paper on the medication.
RhuFab is for the wet form of macular degeneration, not the much more common dry form. The wet form accounts for the vast number of blindness cases. Doctors diagnose 200,000 new cases of wet macular degeneration in the United States each year.
Another drug, Visudyne, is approved for treating the disease. But it mainly slows the deterioration of vision rather than improve it.
Dr. Mark S. Blumenkranz, chairman of ophthalmology at Stanford, said new treatments might be available around 2004 or 2005.
"There is no question that this will be considered the golden era of treatment of this disease," said Dr. Blumenkranz, who is an adviser to Eyetech Pharmaceuticals, which is developing a drug somewhat similar to rhuFab.
Genentech said today that it would begin a trial in the last stage needed for approval of the drug in the first quarter of next year.
Eyetech, based in Midtown Manhattan, is in its final phase of trials. It previously reported that 26 percent of patients had gained three lines of vision in a small trial.
Another drug, Anecortave Acetate, developed by Alcon Laboratories of Fort Worth, is also in final-stage trials. In an earlier trial, whose results were presented today, the drug slowed vision loss compared to a placebo after one year. About 12 percent of treated patients showed an improvement in vision of two lines or more.
Wet macular degeneration is caused by the accumulation of blood vessels under the retina that leak fluid into the eye. The drugs being developed by Genentech, Eyetech and Alcon aim to shrink the network of blood vessels and stop the leakage.
Ernest S. Hayeck, 78, a retired judge from Massachusetts, said in a telephone interview that rhuFab let him resume driving and reading.
"After a couple of injections," Judge Hayeck said, "my eyesight came back dramatically."
He added that his vision was now 20/20, with glasses, nearly four months after the last of his eight monthly injections.
Doctors say previous reports about gains in some patients, including the actor Dabney Coleman, have led desperate patients to besiege them, seeking unavailable and unproven treatments.
"Most of these studies are not ready for prime time," said Dr. Lawrence A. Yannuzzi, a retina specialist in Manhattan. Dr. Yannuzzi was applauded when he criticized doctors for talking prematurely to the press about the drugs.
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