Benzinga | May 3, 2021 08:27AM EDT

Ocular Therapeutix Fulfills Post-Marketing Approval Requirements for ReSure Sealant

Ocular Therapeutix, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, has received notification from the U.S. Food and Drug Administration (FDA) confirming it has fulfilled all post-approval study requirements for ReSure(r) Sealant, with a requirement to update the ReSure label reflecting the study results. As a condition for ReSure's pre-market approval application (PMA) in 2014, the FDA required two post-approval studies to be completed. The first, referred to as the Clinical Post-Approval Study, was completed in 2016. This notification marks the completion of the second, the Device Exposure Registry Study, a retrospective analysis comparing endophthalmitis rates from sites that purchased ReSure Sealant versus sites that did not.