KALA Bio Completes Enrollment in CHASE Phase 2b Trial for Persistent Corneal Epithelial Defect

KALA Bio has announced the completion of enrollment in its CHASE (Corneal Healing After SEcretome therapy) phase 2b clinical trial, marking an important milestone in the development of a potential new treatment for persistent corneal epithelial defect (PCED).

About the CHASE Clinical Trial

The CHASE trial is a multicenter, randomized, double-masked, vehicle-controlled, parallel-group study designed to evaluate the safety and efficacy of KPI-012 ophthalmic solution (3 U/mL and 1 U/mL), a human mesenchymal stem cell secretome (MSC-S), versus vehicle. Patients are dosed topically four times daily (QID) for 56 days.

A total of 79 patients were randomized across 37 sites in the United States and Latin America, all with verified PCEDs at baseline and eligible for inclusion in the primary efficacy analysis. The study’s primary endpoint is complete healing of PCED, measured by corneal fluorescein staining photographs evaluated by a masked central reading center.

Potential to Address a High Unmet Need

“There are currently no US Food and Drug Administration (FDA)-approved products with a broad indication covering all underlying etiologies of PCED,” said Kim Brazzell, PhD, head of R&D and chief medical officer of KALA Bio. “Given its potential to treat all underlying etiologies of PCED, we believe KPI-012 could be a significant advance for the treatment of the estimated 100,000 people with PCED in the United States.”

Brazzell also highlighted the importance of completing enrollment:

“The completion of enrollment in the CHASE trial is a significant milestone in our pursuit to develop and deliver a treatment that addresses the high unmet need for patients with PCED.”

Regulatory Pathway and Next Steps

KALA Bio expects to report topline data from the CHASE trial in the third quarter of 2025. The company believes the study could support a future biologics license application (BLA) submission to the FDA. KPI-012 has already received orphan drug and fast track designations from the FDA, underscoring its potential to address this serious and underserved ocular condition.