Kala completes patient enrollment for CHASE Phase 2 clinical trial

Kala Bio announced the completion of patient enrollment in the CHASE, or Corneal Healing After SEcretome therapy, Phase 2b clinical trial evaluating KPI-012, a human mesenchymal stem cell secretome (MCS-S), for the treatment of persistent corneal epithelial defect, or PCED. The CHASE Phase 2b trial is a multicenter, randomized, double-masked, vehicle-controlled, parallel-group study to evaluate the safety and efficacy of two doses of KPI-012 ophthalmic solution versus vehicle dosed topically QID for 56 days. The CHASE trial randomized 79 patients across 37 sites in the United States and Latin America with verified PCEDs at baseline that will be eligible for inclusion in the primary efficacy analysis. The primary endpoint is complete healing of PCED as measured by corneal fluorescein staining photographs analyzed by a masked central reading center. Kala expects to report topline data in the Q3. Contingent on positive results and subject to discussion with regulatory authorities, the Company believes the CHASE trial could potentially serve as a pivotal trial required to support a Biologics License Application to FDA. KPI-012 has received both Orphan Drug and Fast Track designations from the FDA for the treatment of PCED.