FDA Approves Gel for Sealing Cataract Surgery Incision
Gel breaks down over seven days and is naturally flushed away by the eye's tears
FRIDAY, Jan. 10, 2014 (HealthDay News) -- 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 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 news release.
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.
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. No significant differences were noted in the occurrence of corneal swelling, inflammation, or wound healing. No serious device-related adverse events were reported.
The ReSure Sealant is produced by Ocular Therapeutix, based in Bedford, Mass.
More Information (http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm381139.htm )