Ocular Therapeutix (NSDQ:OCUL) announced today that it reported positive results from a Phase 2 trial of its dry eye disease treatment.
Bedford, Massachusetts-based Ocular Therapeutix’s U.S.-based Phase 2 clinical trial evaluated OTX-DED (dexamethasone intracanalicular ophthalmic insert) for the short-term treatment of dry eye disease.
The randomized, double-masked, vehicle-controlled, multi-center trial evaluated two different formulations of OTX-DED with 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.
According to a news release, the trial of 166 subjects in the modified intent-to-treat (ITT) population was not powered for statistical significance.
The trial found that improvements were seen in VAS dry eye symptoms for both formulations of OTX-DED, with little separation between OTX-DED and the vehicle hydrogel insert. Both formulations had a favorable safety profile and were generally well-tolerated.
In the trial, there were two non-ocular serious adverse events, both in the vehicle hydrogel insert group. They were evaluated to not be related.
“Results of the trial showed statistically significant improvement in bulbar conjunctival hyperemia in patients with dry eye disease for OTX-DED compared with the vehicle hydrogel control for both OTX-DED formulations,” Ocular Therapeutix President of Ophthalmology & CMO Dr. Michael Goldstein said in the release. “OTX-DED is a new, investigational, physician-administered, preservative-free intracanalicular insert designed to deliver dexamethasone and offering the potential to provide a differentiated treatment.”
