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, today announced the receipt of a warning letter from the U.S. Food and Drug Administration (FDA) dated October 17, 2018 and received on October 18, 2018. The letter relates to Ocular’s compliance with data collection and information reporting obligations in a post-approval Device Exposure Registry study required as a condition for approval of the premarket approval (PMA) application for ReSure® Sealant. The Company is required to provide periodic reports to the FDA on the progress of this post-approval study until it is completed. The Company has had discussions with the FDA regarding the conduct of the study and intends to respond to the warning letter from the FDA within the required 15 day period.
Ocular Therapeutix takes the warning letter seriously and is committed to working with the FDA to address and resolve the concerns cited in the warning letter.
ReSure Sealant, a hydrogel ophthalmic wound sealant, is a product currently indicated for intraoperative management of clear corneal incisions (up to 3.5mm) with a demonstrated wound leak for which a temporary dry surface can be achieved, in order to prevent postoperative fluid egress from such incisions following cataract surgery with intraocular lens placement in adults.