FDA Panel Recommends Macular Degeneration Drug
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, maintaining independence.
- 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.