Phase 2 study begins for sustained-release postop therapy

Ocular Therapeutix Inc. announced it has completed enrollment for its sustained release dexamethasone in a phase 2 study under an Investigational New Drug submission to the U.S. Food and Drug Administration, according to a company press release.

This study will evaluate the safety and efficacy of the sustained release dexamethasone (OTX-DP) for the treatment of postoperative inflammation and pain, according to the release.

OTX-DP is administered as a one-time bioabsorbable intracanalicular plug and releases the corticosteroid to the ocular surface over a 2-week period followed by a 2-week taper, the release said.

The study will include 60 patients undergoing clear corneal cataract surgery at four sites in the U.S. Patients randomized to the OTX-DP study arm were administered the drug-eluting plug at the conclusion of surgery, and a proprietary placebo intracanalicular plug was placed in the control group. Primary endpoints are reduction of inflammation and pain, according to the release.

“A sustained, low-dose dexamethasone plug could ensure consistent and continuous corticosteroid concentrations on the ocular surface, which may in turn minimize side effects and achieve better results,” Amar Sawhney, PhD, president and chief executive officer of Ocular Therapeutix, said in the release.