The US Food and Drug Administration’s (FDA) Ophthalmic Devices Panel announced that Ocular Therapeutix’s ReSure sealant is safe and effective in managing clear corneal wound leaks following cataract surgery.
ReSure Sealant is a synthetic, biocompatible hydrogel that creates a temporary, soft and lubricious surface barrier to protect clear corneal incisions in the immediate post-operative period when wounds are most vulnerable.
The panel has favorably voted the company's ReSure sealant after reviewing the data from ReSure sealant pivotal study, a 488-patient controlled, multi-center, randomized, prospective clinical trial.
ReSure sealant showed statistical superiority over sutures for the primary endpoint of prevention of wound leaks within the first seven days post-operatively and demonstrated successful prevention of wound leaks in 95.9% of cases.
The sealant also demonstrated fewer adverse events when compared to suture and was well-tolerated by patients.
Ocular Therapeutix is looking forward to work with FDA towards approval of the ReSure sealant.
