Ophthalmic Devices Panel Supports Safety For Ocular Therapeutix’ ReSure Sealant, But Other Votes Mixed
This article was originally published in The Gray Sheet
Executive Summary
The FDA panel voted 9-1 in favor of the safety of Ocular’s PMA Sept. 19, but 5-1 on whether the benefits of the device, an in situ-formed hydrogel that creates an adherent temporary, soft and lubricious sealant to prevent leakage from clear corneal incisions, outweigh its risk, and 5-3 on its effectiveness. Multiple panelists abstained from the last two votes based on concerns with wording of the indication.