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.

Ocular Therapeutix filed for PMA approval in February, based on a 488-patient clinical trial. The sealant's proposed indication is for temporary sealing of clear corneal incisions to prevent leakage of fluid after cataract or intraocular lens placement surgery. While the FDA is not bound by the recommendations of its advisory panels, the agency often follows their advice.

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Some panelists said they were unable to adequately assess the benefits vs. the risks of ReSure or whether it proved superiority over suture, given the conduct of the study, which included 370 protocol deviations.

Several panelists during the Gaithersburg, Md., meeting said that some word-smithing to the product's proposed labelling would have changed their "no" votes on effectiveness to "yes."

Labeling is important "so that surgeons don't imagine this is the same as a stitch," panelist Dr. Jayne Weiss of LSU Health Science Center in New Orleans said.

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