Biopharmaceutical company Ocular Therapeutix Inc (NASDAQ:OCUL) said on Friday that it has refiled its New Drug Application (NDA) with the US Food and Drug Administration (FDA) for its lead product candidate DEXTENZA (dexamethasone insert) 0.4mg for treating ocular pain following ophthalmic surgery.

The company stated that the resubmission is intended to address manufacturing deficiencies cited by the US FDA in its July 2017 Complete Response Letter.

While the resubmission is significant, the company's expects 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, added CEO Antony Mattessich.

According to the company, 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. Following treatment, DEXTENZA is intended to resorb and exit the nasolacrimal system without the need for removal as well as completed Phase 3 evaluation for ocular pain and inflammation following ocular surgery.