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Ocular Therapeutix submits premarket approval application for hydrogel sealant

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Ocular Therapeutix has submitted a premarket approval application to the U.S. Food and Drug Administration for ReSure sealant, according to a company news release.

The sealant, which uses the company’s proprietary hydrogel technology, has the proposed indication of intraoperatively managing clear corneal incisions with a wound leak and preventing fluid egress after cataract surgery or IOL placement, the release said.

The application follows a prospective, randomized, parallel-arm, controlled, subject-masked pivotal clinical trial involving 488 subjects at 24 U.S. sites that compared the sealant with sutures in the week after cataract surgery, the release said.

Ocular Therapeutix said the sealant may be available to clinicians by the end of the year if the FDA approves the application, according to the release.