FDA Ophthalmic Devices Panel Favorably Votes for the Ocular Therapeutix, Inc.'s Resure® Sealant
9/20/2013 7:45:21 AM
FDA Ophthalmic Devices Panel Favorably Votes for the Resure® Sealant
September 19, 2013 -- The Food and Drug Administration's (FDA) Ophthalmic Devices Panel concluded that ReSure Sealant (Ocular Therapeutix, Inc., Bedford, MA), a first-of-a-kind medical device in the United States, is safe and effective for the management of clear corneal wound leaks following cataract surgery.
During this meeting, the panel reviewed data from the ReSure Sealant Pivotal Study, a 488-patient controlled, multi-center, randomized, prospective clinical trial. For the primary endpoint of prevention of wound leaks within the first 7 days post-operatively, the ReSure Sealant demonstrated statistical superiority over sutures. The ReSure Sealant successfully prevented wound leaks in 95.9% of cases, compared to sutures at a rate of only 65.9%. Use of the ReSure Sealant was associated with fewer adverse events when compared to suture and was well-tolerated by patients.
"Prior to device application, nearly half of all clear corneal wounds spontaneously leaked in the trial, while the majority of remaining incisions leaked with minimal provocation," stated Amar Sawhney, President and CEO of Ocular Therapeutix, Inc. "Surgeons may overestimate the integrity of clear corneal incisions and may not consider forces which may be encountered by the wound post-operatively. Suturing has so far been the best definitive recourse for treating leaking wounds, however, in this trial the ReSure Sealant was demonstrated to be superior to sutures for management of wound leaks. Additionally, there were fewer device-related and total adverse events in the ReSure Sealant group, thus establishing a strong safety profile. We are pleased that the panel has recognized this important advance with their vote of confidence and look forward to working with FDA toward approval of the ReSure Sealant."
The ReSure Sealant is a synthetic, polyethylene glycol (PEG)-based hydrogel which is applied as a liquid and gels 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.
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. FDA approval of an ophthalmic sealant would provide surgeons a novel means of wound closure for vulnerable incisions.
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.
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