Ocular Therapeutix announced that its phase 2 trial of its intracanalicular insert for the treatment of dry eye disease did not meet primary endpoints.
The U.S.-based, randomized, double-masked, multi-center, vehicle-controlled clinical trial of OTX-CSI was designed to evaluate safety, tolerability, durability, and efficacy of two different formulations of OTX-CSI. The study, however, failed to show separation between the OTX-CSI treated subjects (both formulations) and the vehicle-treated subjects (both formulations) for the primary endpoint of increased tear production at 12 weeks as measured by the Schirmer’s Test.
According to Ocular, the study did show an improvement — though not statistically significant — in eye dryness of subjects.
Earlier this month, the Massachusetts-based biopharma, which focuses on therapies for eye diseases using proprietary bioresorbable hydrogel-based formulation technology, announced that the FDA had approved its insert to treat eye itching associated with allergic conjunctivitis.
