Kala Pharma reports positive safety data in CHASE Phase 2b trial of KPI-012; second cohort initiated

KALA BIO, Inc.

Both patients in open-label first cohort (high dose 3 U/mL QID) completed at least 1 week with no safety issues.
Second cohort is randomized, double-masked, vehicle-controlled study of ~90 patients testing two doses vs vehicle for 56 days.
Primary endpoint is complete healing of PCED measured by corneal fluorescein staining.
Topline safety and efficacy data expected in Q1 2024; positive results could support first pivotal trial for BLA.

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