Ocular Therapeutix launches another pivotal for Dextenza eye drug-device combo

Ocular Therapeutix (NSDQ:OCUL) said today that it launched another pivotal trial for its Dextenza drug-device combination, its 2nd study of the treatment for an allergic conjunctivitis indication. Bedford, Mass.-based Ocular Therapeutix has had mixed results with Dextenza, formerly known as OTX-DP, which 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. In March, Ocular said a 1st, 247-patient trial examining Dextenza for reducing pain and inflammation after cataract surgery showed that 33.7% of the Dextenza arm showed no inflammatory cells after 14 days, compared to 14.6% for the placebo control arm. Some 76.1% of patients receiving the drug reported no pain after 8 days, compared to 36.1% of the placebo arm. But Dextenza failed to meet a key endpoint the 2nd clinical trial for the pain & inflammation indication, the company said in April. The 240-patient trial met its pain endpoint but missed the inflammation endpoint. Although 77.5% of patients in the Dextenza arm reported no pain after 8 days, compared with 58.8% of the control arm, the difference in inflammatory cell counts after 14 days was not statistically significant (39.4% vs. 31.3%), the company said, noting that both endpoints had to be met to consider the study a success. Founder & CEO Amar Sawhney said Ocular is also pursuing a new drug application for Dextenza in...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Clinical Trials Drug-Device Combinations Optical/Ophthalmic Ocular Therapeutix Source Type: news