Ocular Therapeutix announced today it has received approval from the Food and Drug Administration (FDA) to commercialize the ReSure Sealant in the United States, with an indication for prevention of postoperative fluid egress from incisions with a demonstrated wound leak following cataract surgery. The ReSure Sealant is the first and only sealant that is FDA-approved for ophthalmic use.
The ReSure Sealant was evaluated in a prospective, controlled, randomized, multicenter clinical trial for prevention of fluid egress in clear corneal incisions against sutures, and demonstrated superiority over sutures by successfully preventing wound leaks in 95.9% of cases, compared to sutures in only 65.9% (p<0.0001) of cases. The ReSure Sealant also demonstrated significantly fewer device-related adverse events than the control group (p<0.0001), at 1.6% versus 30.6% respectively.
"Eye surgeons have been waiting for an alternative to suture that is easy to apply, comfortable for the patient, and doesn't require removal following surgery. Beyond those advantages, the ReSure Sealant has shown itself to be even more effective than suture in sealing corneal incisions against the real-world forces that can cause wound leaks after cataract surgery," stated John Hovanesian, MD, of Harvard Eye Associates and a Principal Investigator in the Pivotal Clinical Trial. "I foresee this device becoming a staple in ophthalmic practices nationwide."
The ReSure Sealant is a patented polyethylene glycol-based (PEG) hydrogel which is applied as a liquid and gels on the surface of the eye in less than 20 seconds. Once the ReSure material gels, it remains localized over the incision to seal the wound and form a lubricious surface barrier. The material is designed to stay on the incision in the immediate post-operative period when wounds are most vulnerable, after which it gently sloughs off in the patient's tears.
"Receiving approval to commercialize this product is a huge milestone for the company," stated Amar Sawhney, PhD, President and CEO of Ocular Therapeutix, Inc. "We expect this novel product will enable surgeons to optimize post-operative care of their patients, and look forward to a successful launch in the United States."
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