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.

item 8.01

This headline and bullets were generated automatically by deepseek-v4-flash:cloud@v2 from the public filing. Read the source on SEC.gov before relying on any specific claim. Not investment advice. See methodology for how this pipeline works.