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.
BenevolentAI reports positive Phase Ia safety and pharmacokinetic data for BEN-8744
Thermo Fisher Scientific unveils CorEvitas registry for generalized pustular psoriasis
Nektar Therapeutics commences Phase 2b rezpegaldesleukin clinical trial for alopecia areata
Innovent Biologics doses first participant in first-in-human phase one clinical trial of IBI3002
Ananda Developments secures CBD Drug Supply Agreement for endometriosis clinical trial
Trellus Health secures agreement with major US health plan for IBD management
Chemomab secures new patents for CM-101 monoclonal antibody
argenx receives FDA priority review for VYVGART Hytrulo in CIDP