Positive topline results for Dextenza (dexamethasone insert) in post-surgical ocular inflammation and pain- Ocular Therapeutix

Ocular Therapeutix announced positive topline results from its phase III clinical trial of Dextenza (dexamethasone insert) 0.4 mg, for the treatment of post-surgical ocular inflammation and pain. 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. 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. For clarification of the endpoints, the day of surgery and insertion of Dextenza or the placebo is considered to be day 1.

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 company is preparing for the resubmission to an NDA for Dextenza for the post-surgical ocular pain indication by the end of the year, and subject to potential approval, plans to submit an NDA supplement for Dextenza to include a post-surgical ocular inflammation indication.