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, announced it has received a letter from the U.S. Food and Drug Administration (FDA) dated September 2, 2020 closing out the Warning Letter it received from the FDA on October 18, 2018 concerning ReSure® Sealant. The violation cited in Warning Letter (CMS #564663) has been addressed and Ocular is committed to sustained compliance with all federal regulations.
"We are very excited to have cleared the way for ReSure's future" said Antony Mattessich, President and Chief Executive Officer of Ocular Therapeutics. "ReSure is well-regraded by anterior segment surgeons and fits perfectly into the bag with Dextenza. This resolution gives us the confidence to begin active promotion of ReSure and realize the synergies of a two-product field force."
The Warning Letter was issued to Ocular based on the observed inability to conduct a study evaluating endophthalmitis rates following ReSure use in a post-approval Device Exposure Registry study required under 21 CFR 814.82(a)(2) as a condition within the premarket approval (PMA) application. It was determined the ability to enroll a study evaluating endophthalmitis rates was prohibitively challenging due to the size of the study that would have required tens of thousands of patients. Ocular has come to an agreement with the FDA to conduct a retrospective study looking at sites with access to ReSure compared to those without access to ReSure using the American Academy of Ophthamology's Iris Registry data base.