Ocular Therapeutix, Inc. announced today that the U.S. Food and Drug Administration (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.
“Our goal was to fill a void in the marketplace for a device that can enhance post-operative care of cataract patients by providing greater certainty of wound closure,” stated Amar Sawhney, President and CEO of Ocular Therapeutix, Inc. “We feel the data from our clinical trial meets that goal, and our team looks forward to presenting our safety and efficacy results to the panel.” The randomized, parallel-arm clinical trial enrolled 488 patients at 24 investigative sites throughout the United States. The study tested the safety and efficacy of the device, relative to sutured closure, for prevention of fluid egress within the first 7 days following surgery.
Cataract surgery is the most commonly performed surgery in the United States, with approximately 3.5 million procedures conducted annually (Market Scope, 2008). Clear corneal cataract wound leaks are widely thought to be a contributing factor to some post-surgical complications. Presently, ophthalmologists use stromal hydration to close these wounds, however, recent reports in the literature suggest this method of wound closure may not be adequate to provide a watertight seal.1 FDA approval of an ophthalmic sealant would provide surgeons a novel means of wound closure for vulnerable incisions.
1 Masket S, Hovanesian JA, et al. Use of a calibrated force gauge in clear corneal cataract surgery to quantify point-pressure manipulation. J Cataract Refract Surg. 2013 Apr; 39(4):511-8.