KALA Bio completes enrollment of CHASE clinical trial

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KALA Bio recently announced the completion of enrollment of its CHASE (Corneal Healing After SEcretome therapy) phase 2b clinical trial.¹ The CHASE trial is for the evaluation of KPI-021 ophthalmic solution (3 U/mL and 1 U/mL), a human mesenchymal stem cell secretome (MCS-S), versus vehicle dosed topically QID for 56 days for the treatment of persistent corneal epithelial defect (PCED).¹

“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 patient with PCED,” said Kim Brazzell, PhD, head of R&D at chief medical officer of KALA, in a press release.

“There are currently no US Food and Drug Administration (FDA)-approved products with a broad indication covering all underlying etiologies of PCED. Given its potential to treat all underlying etiologies of PCED, we believe KP-012 could be a significant advance for the treatment of the estimated 100,000 people with PCED in the United States.”

A multicenter, randomized, double-masked, vehicle-controlled, parallel-group study, the CHASE phase 2b trial will evaluate the safety and efficacy of two doses of KPI-012. Seventy-nine patients were randomized across 37 sites in the United States and Latin America, all who have verified PCEDs at baseline eligible for inclusion in the primary efficacy analysis.¹ The study’s primary endpoint is complete healing of PCED, measured by corneal fluorescein staining photographs analyzed by a masked central reading center.

KALA said in a press release that it expects to report topline data from the study in the third quarter of 2025 and believes the CHASE trial could lead to receiving a biologics license application (BLA) from the FDA. KPI-012 has already received both orphan drug and fast track designations from the FDA.¹

Reference:

1. KALA BIO Announces Completion of Enrollment in CHASE Clinical Trial Evaluating KPI-012 for the Treatment of Persistent Corneal Epithelial Defect (PCED) | KALA BIO, Inc. KALA BIO, Inc. Published 2025. Accessed July 10, 2025. https://investors.kalarx.com/news-releases/news-release-details/kala-bio-announces-completion-enrollment-chase-clinical-trial