Core Insights - KALA BIO's shares have plummeted 88.3% in a month following the announcement of the failure of its mid-stage study for KPI-012, aimed at treating persistent corneal epithelial defect (PCED) [1] Study Results - The phase IIb CHASE study evaluated the safety and efficacy of two doses of KPI-012 compared to a vehicle control, with 79 patients randomized to receive either treatment [2] - The study did not meet its primary endpoint of complete PCED healing and failed to achieve statistical significance for key secondary efficacy endpoints [3][4] - No significant difference was observed between the KPI-012 treatment group and the placebo group, although the therapy maintained a favorable safety profile [4] Strategic Decisions - Following the study's failure, KALA BIO will discontinue the development of KPI-012 and its mesenchymal stem cell secretome (MSC-S) platform [5][7] - The company plans to implement cost-control measures, including workforce reductions, and will explore strategic alternatives with its secured lender [7][8] - This decision effectively reverts KALA BIO to the preclinical stage, delaying its product advancement and revenue generation prospects [8] Impact on Future Development - The discontinuation of the MSC-S platform will halt preclinical efforts on KPI-012 for limbal stem cell deficiency and other corneal disorders, as well as the development of KPI-014 for rare inherited retinal diseases [9]