FDA Panel Recommends Macular Degeneration Drug
WebMD News Archive
Nov. 17, 1999 (Washington) -- Without taking a formal vote, an advisory
panel to the FDA recommended laser therapy with the light-sensitive agent
called Visudyne (verteporfin) to treat a particularly aggressive form of
macular degeneration that can result in blindness. "The treatment is
effective, but the treatment effect is very modest ... it's not
penicillin," Donald Fong, MD, chair of the Ophthalmic Drugs Subcommittee,
In the wet form of age-related macular degeneration (AMD), leaky blood
vessels grow across the central portion of the retina, or macula, for unknown
reasons and cause scarring. Laser therapy selectively destroys the abnormal
blood vessels, leaving the normal vessels and tissue alone. About 200,000 cases
occur in the U.S. annually, and the ability of current treatments to preserve
useful vision is limited to about 20% of new cases.
Fong says about half of those treated with Visudyne still lost vision, but
he termed it "a step in the right direction." Since the drug is under a
priority review, it could be available in the spring, pending FDA action. If
ultimately approved, Visudyne would be a new approach to treating patients with
the wet form of AMD, a small percentage of people who develop AMD.
Trials for Visudyne focused on those who have the 'classical' form of the
disease, which is considered the most aggressive. In two studies involving more
than 600 patients, researchers compared Visudyne to placebo in patients at
least 50 years old with a variety of macular-related lesions.
The treatment involves a 30-minute drug infusion, and then, 15 minutes
later, a jolt of laser energy aimed into the eye 'turns on' the Visudyne. The
drug then inhibits the growth of abnormal blood vessels, apparently without
damaging normal tissue. According to the manufacturer, 15% more of those
treated with this therapy either stabilized or showed a small loss of vision at
the 12-month follow-up compared with those on placebo.
The improvement could mean the difference between 20/100 and 20/200 vision,
according to drug investigator Neil Bressler, MD, ophthalmologist at Johns
Hopkins University School of Medicine. This is described as clinically
significant for those who have the classic type of AMD.