Kala Pharmaceuticals (NASDAQ:KALA) is up 13% premarket on light volume in reaction to its announcement of positive top line results from a Phase 3 clinical trial, STRIDE 3, evaluating lead candidate KPI-121 in patients with dry eye disease.
The study met the primary endpoint showing
statistically significant improvements in ocular discomfort severity in
both the overall intent-to-treat (ITT) population and in a predefined
subgroup of ITT patients with more severe ocular discomfort. Significant
results were also achieved for total corneal staining at day 15 in the
ITT population.
It plans to refile its U.S. marketing application next quarter based on these data. It received a CRL in August 2019 citing the need to conduct an additional clinical trial.
The company plans to commercialize KPI-121 under
the brand name EYSUVIS (loteprednol etabonate ophthalmic suspension)
0.25% with a specialty sales force of 125 reps (from 100).
https://seekingalpha.com/news/3549637-kala-pharmas-kpiminus-121-successful-in-dry-eye-study-shares-up-13-premarket
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