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.
