Kala Pharma Reveals Safety Data From Stem Cell Therapy Trial For Corneal Defect Impacting Around 240K People In Developed Nations

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  • Kala Pharmaceuticals Inc KALA announced safety data from the first cohort of the CHASE Phase 2b clinical trial evaluating KPI-012, a human mesenchymal stem cell secretome (MCS-S), for persistent corneal epithelial defect (PCED). 
  • The first cohort enrolled two patients treated with a high dose of KPI-012 (3 U/mL) four times per day (QID). 
  • Both patients completed at least one week of dosing with no safety issues observed. The trial will now advance to Cohort 2.
  • The CHASE trial includes two patient cohorts. 
  • Kala targets reporting topline safety and efficacy data in the first quarter of 2024. 
  • Also Read: Alcon Buys Aerie Pharma For $770M To Enhance Its Ophthalmic Pharma Portfolio.
  • Suppose the results are positive and subject to discussion with regulatory authorities. In that case, Kala believes this trial could serve as the first of two pivotal trials required to support the submission of a marketing application to the FDA.
  • Persistent corneal epithelial defect, which is defined as a persistent non-healing corneal defect or wound that is refractory to conventional treatments, is a rare disease with an estimated incidence in the United States of 100,000 cases per year and 238,000 cases per year in the United States, European Union, and Japan combined. 
  • The company ended FY22 with a cash balance of $70.5 million, providing a cash runway into Q1 2025.
  • Price Action: KALA shares are down 3.34% at $15.05 on the last check Monday.
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