Christy Foreman, director of the Office of Device Evaluation in the FDA's Center for Devices and Radiological Health, said prior to the approval, 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," Foreman said in a statement.
During cataract surgery, an eye surgeon makes a small incision in the cornea through which the patient's natural lens is removed and the artificial lens is inserted. In many cases the incision is small and self-sealing after the artificial lens is in place. However, if fluid leaks from the incision, the surgeon may need to close the wound.
The ReSure Sealant kit contains two liquid solutions the eye surgeon mixes together just prior to sealing the incision. Using a foam-tipped applicator provided in the kit, the surgeon applies the mixture directly to the incision.
Within 20 seconds of applying the liquid to eye tissue, a gel forms that adheres to the eye and seals the incision. The gel gradually breaks down over the course of seven days and is cleared from the body by the eye's natural tears.
The FDA reviewed several non-clinical 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 the 471 study participants 295 received the ReSure sealant to stop leakage and 176 received a suture.
The study showed that ReSure Sealant -- manufactured by Ocular Therapeutix in Bedford, Mass., -- was more effective than use of a single suture in preventing incision leakage in the first seven days following cataract surgery, Foreman said.
ReSure Sealant subjects and suture subjects reported similar rates of eye pain and sensation of having something in the eye. There were no significant differences in the occurrence of corneal swelling, inflammation, or wound healing among ReSure Sealant subjects and suture subjects.
The researchers did not report any serious device-related adverse events, but one study participant who received ReSure Sealant required sutures to seal a post-operative incision leak, the FDA said.
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