FDA OKs First Gel Sealant for Use in Cataract Surgery

Megan Brooks

Disclosures

January 09, 2014

The US Food and Drug Administration (FDA) has approved the first gel sealant for use in cataract surgery with intraocular lens placement.

ReSure Sealant (Ocular Therapeutix, Inc) is a synthetic polyethylene glycol hydrogel indicated for prevention of postoperative fluid egress from incisions with a demonstrated wound leak following cataract surgery, the company says in a posted statement.

Until now, stitches were the only option for closing a leaking corneal incision after cataract surgery, the FDA notes in a statement.

"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," Christy Foreman, director of the Office of Device Evaluation in the FDA's Center for Devices and Radiological Health, said in the statement.

The ReSure Sealant kit comes as 2 liquid solutions that the surgeon mixes together and applies to the incision using a foam-tipped applicator. The material gels in 20 seconds and remains localized over the incision to seal the wound and form a lubricious surface barrier. The gel gradually breaks down over the course of 1 week and is cleared from the body by the eye's natural tears.

The ReSure Sealant was evaluated in a prospective, randomized, controlled multicenter trial for prevention of fluid egress in clear corneal incisions in 471 adults; 295 received the ReSure sealant to stop leakage and 176 received a suture.

The gel sealant was more effective than a single suture in preventing incision leakage in the first 7 days following surgery, the FDA said.

Rates of eye pain and sensation of having something in the eye were similar in the 2 groups.There were also no significant differences in the occurrence of corneal swelling, inflammation, or wound healing among ReSure Sealant and suture patients, according to the FDA. No serious device-related adverse events were reported.

The device is approved for use on cataract surgeries on patient with clear corneas. The device was not studied on patients with clouded corneas.

The FDA notes that the study excluded adults with a history of eye trauma or surgeries; individuals with certain diseases such as insulin-dependent diabetes, glaucoma, or malignancies; and those who used certain medications in the weeks prior to cataract surgery.

"Eye surgeons have been waiting for an alternative to suture that is easy to apply, comfortable for the patient, and doesn't require removal following surgery. Beyond those advantages, the ReSure Sealant has shown itself to be even more effective than suture in sealing corneal incisions against the real-world forces that can cause wound leaks after cataract surgery," John Hovanesian, MD, of Harvard Eye Associates, and a principal investigator in the pivotal clinical trial, said in the company statement.

"I foresee this device becoming a staple in ophthalmic practices nationwide," he said.

The FDA said the company will perform a postapproval study evaluating at least 4857 patients undergoing clear corneal cataract surgery to gather more information on the incidence of adverse events associated with ReSure Sealant.

The FDA's Ophthalmic Devices panel of the Medical Devices Advisory Committee endorsed ReSure Sealant in September 2013, as reported by Medscape Medical News.

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