Ocular Therapeutix Inc. – FDA CRL

The Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to Ocular Therapeutix, Inc., for its New Drug Application (NDA 208742) for a dexamethasone insert. The application cannot be approved in its current state due to several critical issues. A primary concern is rooted in an inspection of Ocular Therapeutix, Inc.'s manufacturing facility, where deficiencies were identified regarding compliance with current good manufacturing practice (CGMP) regulations, specifically 21 CFR Parts 210 and 211. Satisfactory resolution of these manufacturing issues is a prerequisite for approval. For a resubmission, Ocular Therapeutix, Inc. must provide a comprehensive safety update and resubmit the proposed proprietary name, DEXTENZA. Updated labeling content in Structured Product Labeling (SPL) format will also be required once other issues are addressed. Additionally, the FDA recommended providing complete supporting data, including batch manufacturing records and in-process test results, for updated critical material attributes, in-process controls, and yield limits. The agency also advised that any scale-up strategy beyond the current commercial scale should be submitted as a Prior Approval Supplement, citing process complexity. The company has one year to resubmit a complete response addressing all deficiencies to initiate a new review cycle.