Important note: Information in this article was accurate in 1994. The state of the art may have changed since the publication date.
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The Associated Press, Wed, 14 Dec 94
In a study published Wednesday in the Archives of Ophthalmology, researchers said that a double-layered plastic membrane, just four millimeters in diameter, can deliver an anti-viral drug inside the eyeball for up to eight months and suppress a sight-robbing infection called cytomegalovirus, or CMV.
CMV is a common virus that is benign in healthy people but poses a serious threat to patients whose immune system is weak, such as those with AIDS.
Dr. Carl Kupfer, director of the National Eye Institute, said about 25 percent of all AIDS patients develop CMV infection in the eye. Unchecked, the virus can inflame the retina and eventually cause blindness.
CMV infection currently is treated with daily intravenous doses of ganciclovir or foscarnet, a routine that may continue for a lifetime for AIDS patients. But even this therapy is only partially successful, said Kupfer.
"Some drug penetrates from the bloodstream into the eye, but not in high enough concentrations to control the disease progression as well as the drug introduced directly into the eye," said Kupfer.
To constantly bathe the inner eye with the drug, researchers developed a plastic film that can be saturated with ganciclovir. Once implanted in the eye, the drug is slowly released.
In the clinical research, a total of 39 eyes infected with CMV were treated with the implant. Kupfer said that at the end of eight months, the CMV infection had not progressed. In effect, the virus was held in check.
"This is the first time that infection of the retina has been treated by an implant that allows a drug to be released within the eye," said Kupfer. "This allows a very high concentration within the eye."
Although the treatment does not eradicate the CMV, Kupfer said, "if you can prevent the disease from manifesting itself for 240 days, that's important."
In clinical application, Kupfer said, the implant would be replaced about every eight months.
The drug-releasing membrane is implanted during a one-hour operation under local anesthetic. Although some patients experienced blurred vision after the procedure, the side effect cleared up within four weeks, he said.
Blindness caused by CMV infection is becoming an increasingly serious problem among people living with AIDS, said Kupfer.
"The longer they live, the greater the chance that they will get this infection, not only in one eye, but in both eyes," he said.
The implant is now only in experimental clinical trials and has not yet been approved for general use by the Food and Drug Administration. Two additional clinical trials are under way and application for FDA approval of the implant may be made after those trials.
Copyright (c) 1994 - 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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Copyright © 1994 - Associated Press. Reproduction of this article (other than one copy for personal reference) must be cleared through the AP Permissions Desk.
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