Policy & Regulation
Ocular Therapeutix Submits Supplemental New Drug Application for Dextenza for the Treatment of Ocular Inflammation Following Ophthalmic Surgery
11 January 2019 - - US-based biopharmaceutical company Ocular Therapeutix, Inc. (NASDAQ: OCUL) has submitted a supplemental New Drug Application to the US Food and Drug Administration for Dextenza (dexamethasone ophthalmic insert), the company said.

This sNDA filing seeks to expand the current indication for Dextenza to include the treatment of ocular inflammation following ophthalmic surgery.

The company expects that the FDA review will be completed in the second half of 2019.

Dextenza is the first FDA-approved intracanalicular insert delivering dexamethasone to treat post-surgical ocular pain for up to 30 days with a single administration. 

It received FDA approval in November 2018 for the treatment of ocular pain following ophthalmic surgery.

Dextenza is a resorbable, preservative-free ophthalmic insert that is placed in the lower lacrimal punctum and into the canaliculus of the eye.

The sNDA is supported by the two previous Phase 3 clinical trials and safety and efficacy data from an additional prospective, multicenter, randomised, controlled Phase 3 clinical trial of Dextenza (n=438) in cataract surgery patients that demonstrated statistical significance compared to the vehicle control for the endpoints of absence of ocular pain (p