The Associated Press - 8 Dec 1995

A study reaching that conclusion prompted an advisory panel to the Food and Drug Administration to urge, by a 6-1 vote, that Chiron Vision's Vitrasert implant be approved for sale.

But the panel issued a strong warning that AIDS patients cannot simply get the implant and receive no additional treatment, because the virus that is threatening their eyesight can silently invade their other organs and kill them.

"It would be very, very wrong," said Dr. Alexander Brucker, an eye surgeon at the University of Pennsylvania.

Nonetheless, Chiron's shares closed up $2.25 to $106.75 on the Nasdaq Stock Market.

The FDA isn't bound by advisory committee decisions but usually follows them.

At issue is cytomegalovirus, a virus that most people eventually get and never know it but that devastates and even kills AIDS patients, whose immune systems can't fight it off.

CMV can invade the entire body, but 40 percent of AIDS patients get CMV retinitis, where the virus spreads inside the eyeball until they go blind. In the 1980s, blindness was inevitable if these AIDS patients survived long enough. Today, they fight it with two types of drugs, one taken intravenously and one taken orally and intravenously.

The injected drugs, ganciclovir and foscarnet, must be taken twice a day for weeks or months, through a catheter that literally leaves patients open to infection. They also cause numerous, severe side effects as the drugs roam through the body. The oral ganciclovir isn't absorbed by the body as well.

So Chiron invented an implant that would allow ganciclovir to seep directly onto the retina. Patients undergo a 45-minute, outpatient eye surgery to stick the capsule behind their retina and it works for about eight months.

A study of 173 patients showed the implant prevented progression of their eye infection about three times longer than intravenous ganciclovir -- for 220 days vs. 72 days.

"This is an important advance but it doesn't cure this disease," said FDA panelist Kevin Frost of the American Foundation for AIDS Research.

The implant means a much higher quality of life, said patient Kevin Kraus, who has had 11 implants to stem the CMV in both his eyes.

"I didn't want a port permanently in my body -- I'm a very active guy," he said. "Yes, I have to recover about three weeks every year for my three surgeries, but I'm a very happy man."

However, none of the study participants who got the implant also took oral ganciclovir to keep the virus from spreading to other organs other than their eyes. Eleven percent were diagnosed with such a spread, mostly to their lungs and colons.

Dr. Chris Mathews of the University of California, San Diego, warned that those were just the patients who were diagnosed. Numerous autopsy studies show CMV almost always has spread to other organs and usually is the undiagnosed cause of death in patients who were known to have CMV retinitis.

The other concern: Only retinal surgeons should perform the operation, because every ophthalmologist is not be skilled enough to place the implant into the eye without tearing the retina, Brucker said.

"We're very concerned that every surgeon who sees dollar signs will rush out to do this," agreed AIDS activist Michael Markow.

Even though such surgeons were the only ones allowed to perform the study, those patients still experienced some temporary vision loss immediately after the operation, which returned after about a week of recovery.

Of more concern, Brucker said, was that 20 percent of the implant patients had a tear in their retinas, compared with just 3 percent of patients who got the intravenous drug.

He acknowledged that CMV retinitis itself causes such retinal tears, as it eats away the coating of the retina until it becomes highly brittle. But the implant may make that happen sooner, Brucker said. He urged Chiron to study what was happening so surgeons could take steps to protect implant patients' retinas.

Copyright 1995/The Associated Press. Reproduced with permission. Reproduction of this article (other than one copy for personal reference) must be cleared through the Permissions Desk, The Associated Press, 50 Rockefeller Plaza, New York, NY 10020.
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