Kala Pharmaceuticals’ (NASDAQ:KALA) EYSUVIS met both primary efficacy endpoints in a Phase 3 trial for the short-term treatment of dry eye disease.
The trial, called STRIDE 3, demonstrated a statistically significant improvement in ocular discomfort severity at day 15 in the overall intent-to-treat population and in the predefined subgroup of patients with more severe ocular discomfort at baseline. The study also met key secondary endpoints in conjunctival hyperemia at day 15 and ocular discomfort severity at day eight.
“We are thrilled with the results of STRIDE 3, which build on our prior clinical experience with EYSUVIS in our Phase 2, STRIDE 1 and STRIDE 2 trials,” Mark Iwicki, Kala’s chairman, president and CEO, said in a statement.
“We are now focusing on finalizing the NDA resubmission, which is targeted for the second quarter of 2020, and on preparing for a potential U.S. approval and launch by the end of the year,” he added.
