Ocular Therapeutix™, Inc., a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, has announced the resubmission of the Company's New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its lead product candidate DEXTENZA™ (dexamethasone insert) 0.4mg, for the treatment of ocular pain following ophthalmic surgery. The resubmission is intended to address manufacturing deficiencies cited by the FDA in the Agency's July 2017 Complete Response Letter.
"We are pleased to announce the resubmission of the DEXTENZA NDA," said Antony Mattessich, President and Chief Executive Officer. "Since last July, we have worked to make substantial improvements in our manufacturing processes and quality oversight that have allowed us to reach this important milestone. However, while the resubmission is significant, our focus remains on the end goal of making DEXTENZA available to physicians and patients. We anticipate that the DEXTENZA resubmission will be designated Class 2 (six-month review) which would imply a target action date under the Prescription Drug User Fee Act at the end of 2018."