BEDFORD, MA — The first gel sealant has been approved to stop leaking fluid through the corneal incision after cataract surgery with intraocular lens placement.
Until the Food and Drug Administration approved the ReSure Sealant Kit, stitches were the only option for closing a leaking corneal incision after cataract surgery.
“The FDA has approved gels like ReSure for sealing small incisions in other parts of the body, such as the lungs, but this is a first-of-its-kind for the eye,” said Christy Foreman, director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health.
The ReSure Sealant Kit, which comes as two liquid solutions that must be mixed together, is applied directly to the incision using a foam-tipped applicator provided in the kit. Within 20 seconds of applying the liquid to eye tissue, a gel forms that adheres to the eye and seals the incision. After seven days, the gel gradually breaks down and is cleared by the eye’s natural tears.
In approving the product, the FDA reviewed several nonclinical and clinical studies, including a randomized clinical study of 471 adult subjects who underwent cataract surgery and experienced leakage from their incision at the time of operation. Out of the 471 study participants 295 received the ReSure sealant to stop leakage and 176 received a suture. That study showed that ReSure Sealant was more effective than use of a single suture in preventing incision leakage in the first seven days following cataract surgery.
Rates of eye pain and sensation of having something in the eye did not differ between the two groups, and there were no significant differences in the occurrence of corneal swelling, inflammation or wound healing.
ReSure Sealant is manufactured by Ocular Therapeutix in Bedford, MA. The company will perform a post-approval study evaluating at least 4,857 patients undergoing clear corneal cataract surgery to gather further information on the incidence of adverse events associated with ReSure Sealant.