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B&L may defer NDA filing of Retisert for 12 months

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ROCHESTER, N.Y. — Bausch & Lomb is delaying seeking regulatory approval of a drug-delivery implant for the treatment of posterior uveitis. Commercialization may now occur as late as 2005.

Retisert, the drug-delivery implant, was granted both fast track and orphan drug status by the Food and Drug Administration. Bausch & Lomb had initially targeted mid-2003 for approval filing, but now believes that application could be deferred until mid-2004. A company news release indicated that after a recent review of the potential filing strategies with the FDA, the company estimates its application may be delayed.

Initial clinical trial results from the first pivotal trial of the drug are still expected by mid-year, company officials stated. In addition to the posterior uveitis indication, Retisert is also in trials for the treatment of diabetic macular edema.