Massachussetts company Ocular Therapeutix tells us its ReSure Sealant has become 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 this approval, stitches were the only option for closing a leaking corneal incision after cataract surgery in the United States.
Background
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. During cataract surgery, a small incision is made 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, which is where the ReSure Sealant kit comes in. Following the sealing procedure the ReSure gel gradually breaks down over the course of seven days and is cleared from the body by the eye’s natural tears.
Ocular Therapeutix will now 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.
Ocular Therapeutix is the brainchild of Amar Sawhney, serial inventor and entrepreneur behind Duraseal and the ultimately ill-fated Pleuraseal, both hydrogels produced under the Confluent Surgical banner, sold to Covidien, subsequently to be shipped off to Integra as we reported only last week.
Physician comments
“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.” stated John Hovanesian, MD, of Harvard Eye Associates and a Principal Investigator in the Pivotal Clinical Trial. “I foresee this device becoming a staple in ophthalmic practices nationwide.”
FDA comments
“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.
Source: FDA, Ocular Therapeutix, Inc.
published: January 20, 2014 in: Approval/Clearance, Ophthalmics