The company 'takes the warning letter seriously.'
BEDFORD, MA -- Ocular Therapeutix Inc., a biopharmaceutical company focused on eye conditions, announced the receipt of a warning letter from the U.S. Food and Drug Administration dated Oct. 17.
The letter relates to Ocular’s compliance with data collection and information reporting obligations, according to a press release from the company. The study is required for approval of ReSure Sealant. The company is required to provide periodic reports to the FDA on the progress of the post-approval study until it is completed.
The company said it will respond to the letter 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," according to the release.
ReSure Sealant, a hydrogel ophthalmic wound sealant, is described as "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."