Bedford, MA's Ocular Therapeutix is one step closer to winning FDA approval for its ReSure Sealant, convincing a panel of agency advisers that its offering is safe and effective on corneal wounds.
The Ophthalmic Devices Panel voted to recommend ReSure for full approval, Ocular said, looking at data from the sealant's 488-patient pivotal trial in which it beat out traditional sutures in preventing corneal incision leaks after cataract surgery. Seven days after operation, ReSure stopped leakage in 95.9% of cases, while sutures kept wounds shut at a rate of 65.9%, the company said.
Furthermore, ReSure patients endured fewer device-related and total adverse events, Ocular CEO Amar Sawhney said, making the company's sealant both safer and more effective than the standard of care.
"We are pleased that the panel has recognized this important advance with their vote of confidence and look forward to working with FDA toward approval of the ReSure Sealant," Sawhney said in a statement.
The panel's thumbs-up doesn't guarantee FDA approval, though it certainly makes it more likely. If approved, ReSure would be the only sealant of its kind indicated for ophthalmic use.
ReSure is a synthetic hydrogel applied to the eye after cataract surgery. Starting as a liquid, ReSure gels after application, forming a protective seal over incisions and then gradually hydrolyzing before sloughing off in a patient's tears.
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