Ocular Therapeutix has obtained approval from the US Food and Drug Administration (FDA) for its ReSure sealant, indicated for prevention of postoperative fluid egress from incisions with a demonstrated wound leak following cataract surgery.
Approval allows Ocular Therapeutix to market its ReSure sealant, a polyethylene glycol (PEG)-based hydrogel, in the US.
Ocular Therapeutix claims that the ReSure sealant is the first and only sealant that is FDA-approved for ophthalmic use.
ReSure sealant kit includes two liquid solutions that are mixed together just before the use. The kit also includes a foam-tipped applicator used for applying the mixture directly to the incision.
The sealant is applied as a liquid and gels in situ on the ocular surface. Within 20 seconds of applying the liquid to eye tissue, a gel forms on the eye and seals the incision.
The gel gradually breaks down over the course of seven days and is cleared from the body by the eye’s natural processes.
Ocular Therapeutix has evaluated the ReSure sealant in a randomised, multicentre clinical trial for prevention of fluid egress in clear corneal incisions against sutures. This study demonstrated superiority over sutures by successfully preventing wound leaks in 95.9% of cases, compared with sutures in only 65.9% of cases.
In addition, the ReSure sealant demonstrated significantly fewer device-related adverse events than the control group.
Ocular Therapeutix president and CEO Dr Amar Sawhney: "We expect this novel product will enable surgeons to optimise post-operative care of their patients, and look forward to a successful launch in the United States."
Image: Cataract surgery is the most commonly performed surgery in the US. Photo: courtesy of EyeMD.