BioCentury
ARTICLE | Clinical News

Ocular's OTX-DP misses in Phase III study

April 7, 2015 12:22 AM UTC

Ocular Therapeutix Inc. (NASDAQ:OCUL) lost $12.98 (34%) to $25.32 in early after-hours trading on Monday after its dexamethasone-loaded punctum plug ( OTX-DP) missed one of two primary efficacy endpoints in the second of two Phase III trials to treat pain and inflammation associated with cataract surgery.

In the 240-patient study, 39.4% 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. 31.3% of patients who received a vehicle-loaded plug (p=0.2182). In the OTX-DP arm, 77% of patients in were pain-free on day 8 vs. 58.8% of the placebo group (p=0.0025). Ocular said the therapy had to meet both efficacy endpoints for the trial to be considered a success. ...