BEDFORD, Mass., Sept. 4, 2012-- Ocular Therapeutix, Inc. announced today it has completed enrollment for its ReSure Sealant Pivotal Clinical Trial, designed to gain Premarket Approval (PMA) by the U.S. Food and Drug Administration (FDA). The trial enrolled 488 patients at 24 investigative sites throughout the United States.
ReSure Sealant is a polyethylene glycol (PEG)-based hydrogel which is applied as a liquid and then gels to form a barrier on the ocular surface. The device is being studied for prevention of postoperative fluid egress on clear corneal incisions following cataract or intraocular lens placement surgery. The randomized, parallel-arm clinical trial is investigating the safety and efficacy of the device, relative to sutured closure.
Cataract surgery is the most commonly performed surgery in the United States, with well over 3 million procedures conducted annually (Market Scope, 2008). Clear corneal wounds commonly leak, and are widely thought to be a contributing factor to some post-surgical complications. Presently, ophthalmologists use stromal hydration to close these wounds, however, literature has shown that this technique results in a transient effect, and may adversely affect vision in the early post-operative period.
"Ocular Therapeutix has designed a trial which demonstrates the product's ability to enhance wound closure by preventing egress of fluids after cataract surgery," stated Jeffrey Levenson, MD, Principal Investigator at Levenson Eye Associates and lead enroller in the study. "A product such as this may prompt physicians to re-evaluate how they deal with their surgical wounds at the conclusion of each cataract procedure," added Ralph Chu, MD, Principal Investigator at Chu Vision Institute.
"We are pleased to have completed enrollment of such a large study which demonstrates our commitment to providing a better means of wound closure for surgeons," stated Amar Sawhney, Ph.D., President and CEO of Ocular Therapeutix, Inc. "We look forward to submitting the data to the FDA in hopes of gaining approval of the device in the United States."
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