FDA accepts review of Kala Pharmaceuticals’ new dry eye treatment KPI-121 0.25%

FDA accepts review of Kala Pharmaceuticals’ new dry eye treatment KPI-121 0.25%

The United States Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for KPI-121 0.25%, an investigational treatment developed by Kala Pharmaceuticals for dry eye disease. This acceptance initiates a comprehensive review process, with a target action date set for August 15, 2019, under the Prescription Drug User Fee Act (PDUFA). If […]