BEDFORD, MA– Ocular Therapeutix, Inc., a biopharmaceutical company focused on the development and commercialization of innovative therapies for diseases and conditions of the eye and founded by Amar Sawhney, announced positive topline results from its phase 3 clinical trial of DEXTENZA (dexamethasone insert) 0.4 mg, for the treatment of post-surgical ocular inflammation and pain.
DEXTENZA is a product candidate administered by a physician as a bioresorbable intracanalicular insert and designed for drug release to the ocular surface for up to 30 days.
“The successful results of this trial represent an important milestone for the Company, and we believe these results not only further validate the ability of DEXTENZA to provide a full post-operative course of therapy with a one-time administration, but also validate the broader utility of our multi-faceted hydrogel drug delivery technology platform,” said Sawhney, President, Chief Executive Officer and Chairman of the company. “We are preparing for the resubmission to our NDA for DEXTENZA for the post-surgical ocular pain indication by the end of the year, and subject to potential approval, we plan to submit an NDA supplement for DEXTENZA to include a post-surgical ocular inflammation indication. This is an exciting time for Ocular Therapeutix, as we advance our lead drug delivery product candidate toward potential commercialization.”
In this Phase 3 clinical trial with DEXTENZA for the treatment of post-surgical ocular inflammation and pain, as well as other DEXTENZA clinical trials completed to date regardless of indication, DEXTENZA has exhibited a strong safety profile and has been generally well-tolerated. There were no treatment-related serious adverse events observed in this Phase 3 clinical trial. DEXTENZA inserts were visible in almost all subjects through Day 30, with 99% present at the primary efficacy endpoint visits.