KALA BIO completes enrollment in Phase 2b trial of KPI-012 for PCED; topline data expected Q3 2025

KALA BIO, Inc.

CHASE trial randomized 79 patients across 37 sites in US and Latin America.
Two doses of KPI-012 (3 U/mL and 1 U/mL) vs vehicle, dosed QID for 56 days.
Primary endpoint: complete healing of PCED by corneal fluorescein staining photos (masked central reading).
Company expects to report topline data in Q3 2025; trial may serve as pivotal for BLA submission.
If positive, CHASE could potentially support BLA to FDA after regulatory discussion.

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