Ocular Therapeutix enrolls first patients in Dextenza phase 3 clinical trial

Ocular Therapeutix Inc. has enrolled the first patients in its third phase 3 clinical trial for Dextenza to treat postoperative ocular inflammation and pain, according to a company release.

The prospective, multicenter, parallel-arm, double-masked study will randomize 436 patients undergoing clear corneal cataract surgery to receive either Dextenza (sustained release dexamethasone) 0.4 mg Intracanalicular Depot or placebo vehicle. Primary endpoints are absence of anterior chamber cells at day 14 and reduction of pain at day 8.

Based on results from the two previous clinical trials, patients will be randomized 1:1, and those treated with high dosage levels of oral nonsteroidal anti-inflammatories will be excluded. Improvements were also made in the training and guidance to the on-site clinical investigators regarding adherence to study protocols, including the appropriate use of rescue medications, the release said.

As a part of its label expansion strategy, the company submitted an FDA New Drug Application and intends to submit supplements based on clinical trial results, the release said.

The company expects top-line efficacy results to be available in late 2016, according to the release.