UPDATE: FDA panel approves Ocular Therapeutix' ReSeal, with reservations

September 20, 2013 by Ingrid Mezo

Ocular Therapeutix gets good and bad news from an FDA advisory panel that reviewed its ReSeal ophthalmic incision sealant.

FDA panel approves Ocular Therapeutix' ReSeal, with reservations

An FDA advisory panel voted yesterday that Ocular Therapeutix's ReSure topical hydrogel post-op sealant is safe, but split on questions of efficacy and whether the benefits of the treatment outweigh its risks.

The FDA's Ophthalmic Devices Panel voted 9-1, with 1 abstention, that the ReSure sealant is safe; 5-3, with 3 abstentions, that it is effective; and 5-1, with 5 abstentions, that its benefits outweigh its risks.

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