ReSure Sealant filed at FDA
Ocular Therapeutix, Inc. announced that the FDA has scheduled an Ophthalmic Devices Panel meeting on September 19, 2013 to discuss, make recommendations, and vote on the company's Premarket Approval (PMA) Application for the ReSure Sealant.
The proposed indication for use under review for the ReSure Sealant is intraoperative management of clear corneal incisions with a wound leak as demonstrated by a Seidel test, and for prevention of postoperative fluid egress following cataract or intraocular lens placement surgery. If approved, the medical device would be the first and only FDA approved sealant for ophthalmic use.
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