FDA panel endorses ReSure sealant, with provisions

An advisory committee to the U.S. FDA has generally endorsed ReSure, a clear corneal wound sealant, but votes were split as most committee members wanted a narrower indication than the company wanted.

ReSure is a synthetic polyethylene glycol hydrogel that forms a temporary barrier to prevent leakage of clear corneal incisions after cataract or intraocular lens surgery. While similar to other available products, none are licensed for ocular use in the United States.

The company, Ocular Therapeutix, Inc., had been seeking the indication "for intraoperative management of clear corneal incisions with a wound leak demonstrated by a Seidel test, and for prevention of postoperative fluid egress following cataract or intraocular lens placement surgery."

Some committee members who voted no or abstained said they would have voted yes if reference to prevention were removed because they didn’t think the data supported prophylaxis.

Members also wanted qualifiers in the labeling, including the fact that the sealant is only temporary, that it should not be used for copious leaks or lacerations, and that it should not be marketed as a substitute for sutures, despite the manufacturer's data demonstrating the sealant's superiority over sutures.

There was unanimous support for a postmarketing study to further assess the product's efficacy, as well as safety endpoints such as increased intraocular pressure and endophthalmitis.