Ocular Therapeutix obtains FDA clearance for ReSure sealant

12 January 2014 (Last Updated January 12th, 2014 18:30)

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.

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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.

"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."

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.