Ocular's corticosteroid plug meets Phase IIIa endpoints

Ocular Therapeutix Inc. (NASDAQ:OCUL) said its dexamethasone-loaded punctum plug ( OTX-DP) met both primary efficacy endpoints in a Phase IIIa trial to treat pain and inflammation associated with cataract surgery. The company expects data this month from a Phase IIIb trial of OTX-DP in the indication and intends to submit an NDA to FDA next quarter.

In the 247-patient Phase IIIa trial, 33.7% of patients in the OTX-DP arm lacked inflammatory cells in the anterior chamber of the study eye 14 days after insertion of the punctum plug vs. 14.6% of patients in the placebo arm, who received a vehicle-loaded plug (p=0.0015). By day eight, 76.1% of patients in the treatment arm reported no pain in the study eye vs. 36.1% of patients receiving placebo (p<0.0001). The hydrogel-based punctum plug delivers sustained- and tapered-release dexamethasone over one month. ...