Ocular Therapeutix Receives FDA Approval for the ReSure Sealant
Ocular Therapeutix, Inc., received approval from the FDA to commercialize the ReSure Sealant in the United States, with an indication for preventing postoperative fluid egress from incisions after cataract surgery, according to a company news release. The ReSure Sealant is the first and only sealant that is FDA approved for ophthalmic use.
In a prospective, controlled, randomized, multicenter clinical trial, the sealant was compared with sutures for the prevention of fluid egress from clear corneal incisions. The ReSure Sealant demonstrated superiority over sutures by successfully preventing wound leaks in 95.9% of cases versus 65.9% of cases (P < .0001). It also demonstrated significantly fewer device-related adverse events than sutures (P < .0001; 1.6% vs 30.6% respectively), according to a company news release.
“Eye surgeons have been waiting for an alternative to suture[s] that is easy to apply, comfortable for the patient, and does not require removal following surgery,” John Hovanesian, MD, of Harvard Eye Associates and a principal investigator in the pivotal clinical trial, said in the news release. “Beyond those advantages, the ReSure Sealant has shown itself to be even more effective than suture[s] in sealing corneal incisions against the real-world forces that can cause wound leaks after cataract surgery. I foresee this device becoming a staple in ophthalmic practices nationwide.”
The ReSure Sealant is a patented polyethylene glycol-based hydrogel that is applied as a liquid and gels on the surface of the eye in less than 20 seconds. Once the 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 postoperative period when wounds are most vulnerable, after which it gently sloughs off in the patient’s tears.