FDA Panel Recommends Macular Degeneration Drug
WebMD News Archive
Among the safety problems associated with Visudyne were severe vision loss
in a dozen cases, most of which got better over time, and skin sensitivity to
light in patients shortly after treatment. The makers of the drug say they plan
to conduct training courses for doctors across the country to apprise them of
the risk and how to minimize it.
"We're basically putting this systemically administered photo-toxic drug
into the body, and we don't know what the long-term effects of these drugs
are," says Fong.
Wiley Chambers, MD, who reviewed the drug for the FDA, says there are
concerns about the lack of data on the drug's safety and effectiveness. These
studies have been done but haven't yet been fully evaluated. Chambers also said
most of the patients need another treatment after three months, thus exposing
this elderly population to more potential side effects.
Still, panelist Jack Cioffi, MD, of the Devers Eye Institute in Portland,
Ore., says Visudyne could stave off vision loss for 6-18 months. For many
patients, this could be important in maintaining vision and, therefore,
- The wet form of age-related macular degeneration (AMD) develops when leaky
blood vessels grow across the central portion of the retina and cause scarring,
leading to vision loss.
- An advisory panel to the FDA is recommending approval for the
light-sensitive drug Visudyne, which, when used in conjunction with laser
surgery, destroys the abnormal vessels while preserving healthy ones.
- The benefit of the drug is modest but effective in preventing loss of
vision in some patients.