Ocular Therapeutix shares plummet as 2nd Phase III misses primary endpoint

Ocular Therapeutix (NSDQ:OCUL) today saw shares dive over 40% after reporting the 2nd phase 3 clinical trial of its Dextenza drug-device combination failed to meet its primary endpoint. Bedford, Mass.-based Ocular Therapeutix’s Dextenza, formerly known as OTX-DP, is designed to deliver sustained dosage of dexamethasone over 4 weeks using a hydrogel plug inserted into a tear duct. The plug then dissolves and is flushed from the body as tears. The primary endpoint for the company’s 2nd Phase III trial of the device, which was exploring the efficacy of the device at treating ocular itching for patients with allergic conjunctivitis, was a significant reduction in ocular itching at 7, 14 and 21 days, the company said. Results from the study indicated a lower, but not statistically significant difference between the placebo group and those implanted with Dextenza, Ocular Therapeutix reported. Shares in Ocular Therapeutix have dropped 42.2% so far, at $6.85 as of 9:37 a.m. EDT. “We are disappointed that the primary endpoint of ocular itching associated with allergic conjunctivitis was not achieved in our second Phase 3 trial in these patients, and this result is inconsistent with what we saw in our 1st Phase 3 trial. We are currently in the process of conducting a thorough analysis of the data from the second Phase 3 trial to fully understand the difference in efficacy between the 2 Phase 3 trials. There was a greater variability in ocular itching exhibited by patien...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Clinical Trials Drug-Device Combinations Optical/Ophthalmic Regulatory/Compliance Ocular Therapeutix Source Type: news