HealthDay News — The FDA has approved a sealant gel to prevent fluid leakage after cataract surgery.
Although gels such as the ReSure Sealant 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 press release.
The ReSure Sealant kit (Ocular Therapeutix) 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.
The product was evaluated in a clinical study of 471 adults. Reported rates of eye pain and sensation of having something in the eye were similar for ReSure Sealant and suture patients.
There were no significant differences in the occurrence of corneal swelling, inflammation or wound healing between the two groups. No serious device-related adverse events were reported.