The US Food and Drug Administration (FDA) Ophthalmic Devices Advisory Panel is scheduled to decide on Ocular Therapeutix’s premarket approval application for the ReSure Sealant in September and may suggest some recommendations.
ReSure Sealant, which is a proprietary synthetic hydrogel polymer applied as a liquid and gels, is designed for ophthalmic use over clear corneal incisions.
The intraoperative management of clear corneal incisions with a wound leak, which has been demonstrated by a Seidel test, and prevention of postoperative fluid egress following cataract or intraocular lens placement surgery are the proposed indication for use under review.
It would be the only FDA-approved sealant for ophthalmic use if it passes the Panel's requirements, providing surgeons a novel means of wound closure for vulnerable incisions.
Ocular Therapeutix president and CEO Amar Sawhney noted the company's aim was to fill a void in the marketplace for a device that can enhance post-operative care of cataract patients by providing greater certainty of wound closure.
"We feel the data from our clinical trial meets that goal, and our team looks forward to presenting our safety and efficacy results to the panel," Sawhney added.
ReSure Sealant was evaluated in a prospective, randomized, parallel arm, controlled, subject-masked US pivotal clinical trial in which 488 subjects were enrolled at 24 sites throughout the US.
The study compared the ReSure hydrogel sealant with sutures for safety and effectiveness within the first seven days following cataract surgery.
