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Ophthalmic Devices Panel Supports Safety For Ocular Therapeutix’ ReSure Sealant, But Other Votes Mixed

The FDA panel voted 9-1 in favor of the safety of Ocular’s PMA Sept. 19, but 5-1 on whether the benefits of the device, an in situ-formed hydrogel that creates an adherent temporary, soft and lubricious sealant to prevent leakage from clear corneal incisions, outweigh its risk, and 5-3 on its effectiveness. Multiple panelists abstained from the last two votes based on concerns with wording of the indication.

FDA’s Ophthalmic Devices panel is clearly behind the safety of Ocular Therapeutix Inc.’s PMA for its ReSure Sealant, but its votes on the product’s effectiveness and whether its benefits outweigh its risks were mixed.

ReSure Sealant is an in situ-formed hydrogel that creates an adherent temporary, soft and lubricious sealant to prevent leakage from clear corneal incisions.

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