An FDA advisory panel will review the ReSure sealant made by Ocular Therapeutix, a hydrogel designed to seal incisions in the eye's cornea.
An FDA advisory panel is slated to convene Sept. 19 to review the pre-market approval application for Ocular Therapeutix Inc.'s ReSure sealant.
The FDA's Ophthalmic Devices Panel will review the PMA for the ReSure product, a hydrogel designed to seal incisions to the cornea made during cataract or intraocular lens placement surgery.
Ocular Therapeutix filed for PMA approval in February, based on a 488-patient clinical trial. The application seeks approval for 2 indications, 1 for wound leaks and another for prevention of post-operative fluid flow. The FDA panel will consider whether the ReSure trial met its safety and efficacy endpoints well enough to merit approval. The agency is not bound by the recommendations of its advisory panels, but often follows their advice.