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First gel for sealing corneal incision after cataract surgery approved by FDA

ReSure gel has only be approved for use after clear corneal cataract surgery.
ReSure gel has only be approved for use after clear corneal cataract surgery.
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Although surgical gels have been approved for sealing small incisions in other parts of the body, such as the lungs, ReSure (manufactured by Ocular Therapeutix in Bedford, MA) is the first to be approved by the FDA to stop fluid from leaking through the incision in a patient’s cornea after cataract surgery. As a result, doctors may be able to forego stitches in many cases.

According to the pharmaceutical company, ReSure Sealant is delivered as two liquid solutions that are mixed together by the surgeon (similar to many epoxies) just before closing the incision. The surgeon then applies it to the cornea using a foam-tipped applicator. A gel then forms within 20 seconds of application, which seals the wound before gradually breaking down over the course of a week and washed from the body by the eye’s natural tears.

“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.”said Christy Foreman, director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health.

In fact, several non-clinical and clinical studies, including a randomized clinical study of 471, only one of the 295 patients who received ReSure following leakage at the time of operation required a suture, along with the 176 remaining test subjects involved who were not given any sealant.*

It was also reported that both sets of patients experienced “similar rates of eye pain and sensation of having something in the eye,” with no discernable difference reported in cases of swelling or inflammation of the cornea.

It should be noted that the clinical trials did not include patients with glaucoma, any malignancies or those with prior history of eye trauma or surgeries. Insulin-dependent diabetics were also omitted from the trials

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