Ocular Therapeutix, Inc. announced today that it has received IDE approval from the U.S. Food and Drug Administration to conduct a pivotal clinical trial with ReSure Sealant, a proprietary synthetic hydrogel polymer for ophthalmic use over clear corneal incisions.
The randomized, parallel-arm clinical trial will test the safety and efficacy of the device, relative to sutured closure, for prevention of postoperative fluid egress on clear corneal incisions following cataract or intraocular lens placement surgery. The trial will be conducted at up to 24 sites throughout the United States.
Cataract surgery is the most commonly performed surgery in the United States, with well over 3 million procedures conducted annually. Clear corneal wound leaks are widely thought to be a contributing factor to many post-surgical complications. Presently, ophthalmologists use stromal hydration to close these wounds, however, recent literature has shown that this technique may not be enough to create a watertight seal, and therefore more protection is necessary. “In a time where wound integrity is under scrutiny, this product fills a void where our only option for closure of vulnerable incisions was sutures,” stated Steven Dell, Medical Director of Dell Laser Consultants. “ReSure Sealant could be a huge step forward for protecting our patients’ eyes post-operatively.”
“We are very excited to have developed a robust study with FDA’s input to definitively demonstrate the utility of the ReSure Sealant compared to older methods of incision closure and management in clear corneal cataract surgery,” stated Amar Sawhney, President and CEO of Ocular Therapeutix, Inc. “We look forward to completing the trial and making the ReSure Sealant available to US physicians by next year.”
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 also using its hydrogel technology for development of sustained ocular drug delivery vehicles, such as absorbable punctum plugs to deliver moxifloxacin for the treatment of bacterial conjunctivitis, and travoprost for the treatment of glaucoma.
About ReSure Sealant:
The ReSure Sealant is a synthetic hydrogel polymer which is applied as a liquid and gels in situ on the ocular surface, creating a soft and lubricious surface barrier. The Sealant is designed to stay on the incision in the immediate post-operative period when wounds are most vulnerable, after which it gently sloughs off in the patient’s tears.
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