Ocular Therapeutix has resolved a warning letter from the FDA regarding requirements of the premarket approval application for ReSure Sealant, according to a press release.
The warning, issued in October 2018, was “based on the observed inability to conduct a study evaluating endophthalmitis rates following ReSure use in a post-approval device exposure registry study,” the release said.
ReSure Sealant is indicated for intraoperative management of clear corneal incisions up to 3.5 mm.
The FDA decided the company’s ability to enroll the thousands of patients needed to conduct
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