KALA BIO, Inc. announced on July 9, 2025, the successful completion of patient enrollment in its CHASE Phase 2b clinical trial. This trial is evaluating KPI-012, a human mesenchymal stem cell secretome (MSC-S), for the treatment of persistent corneal epithelial defect (PCED). The milestone signifies a crucial step forward in the development of this therapy.
The CHASE trial is a multicenter, randomized, double-masked, vehicle-controlled study that enrolled 79 patients across 37 sites in the United States and Latin America. The primary endpoint for the trial is complete healing of PCED, as assessed by corneal fluorescein staining photographs analyzed by a masked central reading center. This comprehensive design aims to provide robust efficacy and safety data.
KALA expects to report topline data from the CHASE trial by the end of the third quarter of 2025. Contingent on positive results and discussions with regulatory authorities, the company believes this trial could potentially serve as one of two pivotal trials required to support a Biologics License Application (BLA) submission to the FDA. KPI-012 has already received Orphan Drug and Fast Track designations for PCED, which may expedite its development and review process.
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