ReSure Sealant, developed by Bedford, Massachusetts-based Ocular Therapeutix, has been approved by FDA for use in closing a leaking corneal incision after cataract surgery with intraocular lens placement in adults.
Cataract surgery involves removing a patient's cloudy cataract lens through a small incision in the cornea and inserting an intraocular lens. Stitches were the only option for stopping fluid from leaking through the incision up until now.
ReSure Sealant, which becomes the first gel to be approved for sealing corneal incision after cataract surgery, comes as two liquid solutions that are to be mixed and directly applied to the incision using a foam-tipped applicator.
The FDA approval of ReSure Sealant was based on the review of 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. In the randomized study, ReSure Sealant was found to be more effective than use of a single suture in preventing incision leakage in the first seven days following cataract surgery.
A post-approval study that will evaluate at least 4,857 patients undergoing clear corneal cataract surgery will be conducted by Ocular Therapeutix to gather further information on the incidence of adverse events associated with ReSure Sealant.
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