JAN 09, 2014
The U.S. FDA has approved the first gel sealant to prevent wound leaks following cataract surgery.
ReSure Sealant is a synthetic polyethylene glycol-based hydrogel. It comes as two liquid solutions that the surgeon mixes together and applies to the incision using a foam-tipped applicator. The material then 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 postoperative period when wounds are most vulnerable, after which it sloughs off in the patient’s tears.
“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,” said Dr. John Hovanesian of Harvard Eye Associates and a principal investigator in a pivotal clinical trial for the product. “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. I foresee this device becoming a staple in ophthalmic practices nationwide.”
ReSure Sealant was compared with sutures in a prospective controlled randomized multicenter clinical trial evaluating the prevention of fluid egress in clear corneal incisions. The product demonstrated superiority over sutures, preventing wound leaks in 96 percent of cases versus 66 percent of cases with sutures (P < 0.0001). ReSure also demonstrated significantly fewer device-related adverse events than the control group (1.6 percent vs. 30.6 percent; P < 0.0001).
The FDA said the company will perform a post-approval study evaluating at least 4,857 patients undergoing clear corneal cataract surgery to gather more information on the incidence of adverse events associated with ReSure Sealant.