Ocular Therapeutix Announces Topline Results for Phase 2 Clinical Trial of OTX-DED for the Short-Term Treatment of Dry Eye Disease

Ocular Therapeutix, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced positive topline results from its Phase 2 clinical trial of OTX-DED (dexamethasone intracanalicular ophthalmic insert) for the short-term treatment of dry eye disease.

The Phase 2 clinical trial is a U.S.-based, randomized, double-masked, vehicle-controlled, multi-center trial evaluating two different formulations of OTX-DED (dexamethasone intracanalicular ophthalmic insert) aimed to enroll approximately 150 subjects with dry eye disease. This trial was designed to assess the safety and efficacy of two formulations of OTX-DED for the short-term treatment of signs and symptoms of dry eye disease by evaluating the primary endpoint of bulbar conjunctival hyperemia and secondary endpoints of eye dryness symptoms using the visual analog scale (VAS), among other methodologies, in each case in comparison with a vehicle hydrogel insert. The clinical trial was not powered for statistical significance.

The clinical trial enrolled 166 subjects in the modified intent-to-treat (ITT) population which included subjects who were randomized and had the OTX-DED insert placed in the study eye. The clinical trial achieved its pre-specified primary endpoint, demonstrating a statistically significant change of bulbar conjunctival hyperemia from baseline to day 15 compared to vehicle hydrogel using a central reading photographic assessment in the modified ITT population. Change from baseline using the CCLRU Grading scale (0-4) was -0.51 for the OTX-DED 0.2 mg group (n=55), -0.43 for the OTX-DED 0.3 mg group (n=56), and -0.21 for the vehicle hydrogel insert group (n=55). These differences were statistically significant compared with the vehicle hydrogel for both the OTX-DED 0.2 mg group (p=.004) and the OTX-DED 0.3 mg group (p=.028). Sensitivity analysis using different methods of imputation including last observation carry forward (LOCF), Markov Chain Monte Carlo (MCMC), and fully conditional specification (FCS) were consistent with the primary analysis. Improvements from baseline were noted in the VAS dry eye symptoms for both OTX-DED 0.2 mg and OTX-DED 0.3 mg groups, but there was little separation between OTX-DED and the vehicle hydrogel insert. Other secondary endpoints are being evaluated.