Ocular Therapeutix™ Announces NDA Resubmission of DEXTENZA™

Ocular Therapeutix™, Inc. (NASDAQ: OCUL), 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.”

About DEXTENZA™
DEXTENZA is a corticosteroid intracanalicular insert placed through the punctum, a natural opening in the eye lid, 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.

About Ocular Therapeutix, Inc.
Ocular Therapeutix, Inc. 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 has resubmitted an NDA for post-surgical pain for its lead product candidate, DEXTENZA™ (dexamethasone insert), which has completed Phase 3 clinical development for the treatment of ocular pain and inflammation following ophthalmic surgery. OTX-TP (travoprost insert) is 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. These intravitreal implants include OTX-TKI, a tyrosine kinase inhibitor (TKI), and, in collaboration with Regeneron, OTX-IVT, an extended-delivery protein-based anti-vascular endothelial growth factor (VEGF) trap, both for the treatment of retinal diseases. Ocular Therapeutix's first product, ReSure® Sealant, is FDA-approved to seal corneal incisions following cataract surgery.