Ocular Therapeutix Announces NDA Resubmission of Dextenza

Ocular Therapeutix has announced the resubmission of the company’s new drug application (NDA) to the 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,” Antony Mattessich, President and Chief Executive Officer, said in a company news release. “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 (6-month review) which would imply a target action date under the Prescription Drug User Fee Act at the end of 2018.”

Dextenza is a corticosteroid intracanalicular insert placed through the punctum into the canaliculus and is designed to deliver dexamethasone to the ocular surface for up to 30 days without preservatives. Following treatment, Dextenza is intended to resorb and exit the nasolacrimal system without the need for removal. Dextenza has completed phase 3 evaluation for the treatment of ocular pain and inflammation following ophthalmic surgery. Upon approval for pain, the company intends to submit an NDA supplement for the treatment of inflammation following ocular surgery. Dextenza is also in phase 3 clinical development for allergic conjunctivitis.