Dextenza (sustained release dexamethasone) filed with FDA for post-surgery pain- Ocular Therapeutix

Ocular Therapeutix has submitted a New Drug Application (NDA) to the FDA for Dextenza (sustained release dexamethasone) 0.4mg Intracanalicular Depot, for the treatment of ocular pain following ophthalmic surgery. The data included in the NDA submission are from a Phase II clinical trial and two Phase III clinical trials conducted with this product candidate.

Comment: The Company intends to submit a supplement to the NDA for the treatment of post-surgical inflammation as part of its label expansion strategy for Dextenza if it obtains favorable results from the third Phase III clinical trial, which is expected to commence later this year, and subject to the approval of the NDA for post-surgical ocular pain by the FDA.