Ocular Therapeutix has received a warning letter from the US Food and Drug Administration (FDA) related to ReSure hydrogel ophthalmic wound sealant.
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.
Ocular Therapeutix is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology.
Ocular Therapeutix’s lead product candidate, DEXTENZA (dexamethasone insert), has completed Phase 3 clinical development for the treatment of ocular pain and inflammation following ophthalmic surgery. The New Drug Application (NDA) for DEXTENZA has a target action date under the FDA Prescription Drug User Fee Act (PDUFA) of December 28, 2018.
OTX-TP (travoprost insert) is an intracanalicular insert in Phase 3 clinical development for the reduction of intraocular pressure in patients with primary open-angle glaucoma and ocular hypertension.
The Company’s earlier stage assets include OTX-TIC, an extended-delivery travoprost intracameral implant for the reduction of intraocular pressure in patients with glaucoma and ocular hypertension, as well as sustained release intravitreal implants for the treatment of retinal diseases.
Source: Company Press Release