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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