FDA approves ReSure Sealant

January 15, 2014

Ocular Therapeutix has received approval from the FDA to commercialize its ReSure Sealant in the United States, with an indication for prevention of postoperative fluid egress from incisions with a demonstrated would leak following cataract surgery.

 

Bedford, MA-Ocular Therapeutix has received approval from the FDA to commercialize its ReSure Sealant in the United States, with an indication for prevention of postoperative fluid egress from incisions with a demonstrated would leak following cataract surgery.

ReSure Sealant is the first and only sealant that is FDA-approved for ophthalmic use, according to Ocular Therapeutix.

“Receiving approval to commercialize this product is a huge milestone for the company,” said Amar Sawhney, PhD, president and chief executive officer of Ocular Therapeutix.

The sealant was evaluated in a prospective, controlled, randomized, multicenter clinical trial for prevention of fluid egress in clear corneal incisions against sutures. It demonstrated superiority over sutures by successfully preventing would leaks in 95.9% of cases, compared to sutures in only 65.9% (p < 0.0001) of cases.

The sealant also demonstrated significantly fewer device-related adverse events than the control group (p < 0.0001), at 1.6% versus 30.6% respectively.

“Eye surgeons have been waiting for an alternative to sutures that is easy to apply, comfortable for the patient, and doesn’t require removal following surgery,” said John Hovanesian, MD, of Harvard Eye Associates and a principal investigator in the pivotal clinical trial. “Beyond those advantages, the sealant has shown itself to be even more effective than suture in sealing corneal incisions against the real-world forces that can cause wound leaks after cataract surgery.

“I foresee this device becoming a staple in ophthalmic practices nationwide,” he continued.

 

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