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.
About the ReSure Sealant:
The ReSure Sealant is a synthetic, polyethylene glycol (PEG)-based hydrogel polymer which is applied as a liquid and gels in situ on the ocular surface, creating a soft and lubricious surface sealant. The ReSure hydrogel is designed to stay on the incision in the immediate post-operative period when wounds are most vulnerable, after which it hydrolyzes and gently sloughs off in the patient’s tears.
About Ocular Therapeutix, Inc.:
Founded in November 2006, Ocular Therapeutix, Inc. is a privately held company based in Bedford, MA, focused on the development and commercialization of ophthalmic therapeutic products using its proprietary hydrogel technology. Ocular Therapeutix is focusing on development of drug-eluting intracanalicular plugs for treatment of glaucoma and post-operative pain and inflammation, injectable depots for back-of-the-eye diseases, and an ocular sealant.
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.
# # #