Ocular Therapeutix resolves FDA warning for ReSure Sealant
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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 such a study was “prohibitively challenging,” and Ocular Therapeutix agreed to conduct a retrospective study comparing sites with and without access to the product, using the American Academy of Ophthalmology’s IRIS Registry to gather data, according to the release.
“This resolution gives us the confidence to begin active promotion of ReSure,” Antony Mattessich, president and CEO of Ocular Therapeutix, said in the release.
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