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FDA approves clinical trial of ReSure Sealant

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BEDFORD, Mass. — The U.S. Food and Drug Administration has granted IDE approval to Ocular Therapeutix for a clinical trial of ReSure Sealant, according to a company news release.

The sealant is a proprietary synthetic hydrogel polymer for use with clear corneal incisions, the release said.

"We are very excited to have developed a robust study with FDA's input to definitively demonstrate the utility of the ReSure Sealant compared to older methods of incision closure and management," Amar Sawhney, president and CEO of Ocular Therapeutix, said in the release. "We look forward to completing the trial and making the ReSure Sealant available to U.S. physicians by next year."

The clinical trial will be a randomized, parallel-arm comparison to sutured closure that will test safety and efficacy related to prevention of postop fluid loss on clear corneal incisions after cataract surgery or placement of IOLs, according to the release. The trial will include up to 24 sites in the United States.