Ocular Therapeutix™ Announces Successful Topline Results For Both Inflammation And Pain Primary Efficacy Endpoints From Phase 3 Clinical Trial Of DEXTENZA™

Ocular Therapeutix, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the development and commercialization of innovative therapies for diseases and conditions of the eye, today 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 trial successfully met its two primary efficacy endpoints for inflammation and pain, achieving statistically significant differences between the treatment group and the placebo group for the absence of inflammatory cells on day 14 and the absence of pain on day 8, respectively. 52.3%% of patients treated with DEXTENZA showed an absence of inflammatory cells in the anterior chamber of the study eye on day 14, compared to 31.1% of those receiving the placebo vehicle control punctum plug (p< 0.0001). 79.6% of patients treated with DEXTENZA reported absence of pain in the study eye on day 8, compared to 61.3% of those receiving the placebo vehicle control punctum plug (p< 0.0001). For clarification of the endpoints, the day of surgery and insertion of DEXTENZA or the placebo is considered to be day 1.

"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 Amar Sawhney, Ph.D., President, Chief Executive Officer and Chairman. "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."

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