Ocular Therapeutix submits sNDA to FDA for Dextenza
Ocular Therapeutix announced the submission of a supplemental New Drug Application to the U.S. Food and Drug Administration for DEXTENZA. The 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. DEXTENZA 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.