Sealant gel approved for eye surgery
(HealthDay)—A sealant gel to prevent fluid leakage after cataract surgery has been approved by the U.S. Food and Drug Administration.
While gels such as ReSure have been approved to seal small incisions in other parts of the body, this is the first such approval for the eye, the agency said in a news release.
A cataract is a gradual clouding of the eye's lens. By age 80, more than half of Americans have either an active cataract or have had cataract surgery, the U.S. National Institutes of Health estimates.
The ReSure Sealant kit includes two liquid solutions that are mixed together just before use. The product is designed to seal an eye incision within 20 seconds of application, the FDA said. The gel then breaks down over seven days and is naturally flushed away by the eye's tears.
No serious adverse reactions to the gel were reported, the FDA said.
Before this approval, stitches were the only option for closing a leaking corneal incision after cataract surgery, the agency said. The product was evaluated in a clinical study of 471 adults.
The ReSure sealant is produced by Ocular Therapeutix, based in Bedford, Mass.