The US Food and Drug Administartion (FDA) has granted an investigational device (IDE) approval to Ocular Therapeutix's ReSure Sealant.
ReSure Sealant which is a proprietary synthetic hydrogel polymer applied as a liquid and gels, is designed for ophthalmic use over clear corneal incisions.
Under the IDE approval, the company will conduct a randomized, parallel-arm clinical trial to test the safety and efficacy of the device, relative to sutured closure, for prevention of postoperative fluid egress on clear corneal incisions following cataract or intraocular lens placement surgery.
Ocular Therapeutix president and CEO Amar Sawhney said they 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 in clear corneal cataract surgery.
"We look forward to complete the trial and make the ReSure Sealant available to US physicians by next year," Sawhney said.