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Retisert receives fast-track designation from FDA
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ROCHESTER, N.Y. — An intravitreal implant for treating noninfectious posterior uveitis has been accepted for review by U.S. regulators and granted fast-track status, according to a press release.
Bausch & Lomb’s Retisert implant had already received orphan drug status from the Food and Drug Administration for the same indication, the company said. B&L expects to receive FDA notification of approval or rejection by spring 2005 and to commercialize the implant during 2005 if granted approval, the company said in the release.
The FDA’s fast-track designation allows fast review of novel therapies for serious diseases for which there is an unmet medical need. Current therapies for noninfectious uveitis include injections of steroids in or around the eye or high doses of systemic steroids that may cause serious side effects, according to B&L.
A recent multicenter international study showed that recurrence of uveitis was lower in eyes implanted with Retisert than in unimplanted fellow eyes. The trial included 239 patients. After 34 weeks, eyes with the implant had a uveitis recurrence rate of 10%, compared with 57% of fellow eyes.