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.” About the ReSure Sealant: The ReSure Sealant is a synthetic, polyethylene glycol (PEG)-based hydrogel 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.