The U.S. Food and Drug Administration today approved the first gel sealant for use in stopping fluid from leaking through the incision in a patient’s cornea after cataract surgery with intraocular lens placement in adults. Prior to today’s 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,” said Christy Foreman, director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health.
A cataract is a gradual clouding of the eye's lens that results in vision loss. Cataracts are often the result of aging, but can have other causes. According to the National Institutes of Health, by age 80, more than half of all Americans have either a cataract or have had cataract surgery. Cataract surgery is a procedure to restore vision by removing the eye’s natural lens and replacing it with an artificial lens.
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 comes as two liquid solutions that the 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.
In support of the approval, 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 was more effective than use of a single suture in preventing incision leakage in the first seven days following cataract surgery. 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. Researchers did not report any serious device-related adverse events. One study participant who received ReSure Sealant required sutures to seal a post-operative incision leak.
The study excluded individuals with a history of eye trauma or surgeries; individuals with certain diseases such as insulin-dependent diabetes, glaucoma, or malignancies; and individuals who used certain medications in the weeks prior to cataract surgery. The device is approved for use on cataract surgeries on patient with clear corneas. The device was not studied on patients with clouded corneas.
ReSure Sealant is manufactured by Ocular Therapeutix in Bedford, Mass. 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.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.