Kala Pharmaceuticals receives FDA Fast Track designation for KPI-012

Kala Pharmaceuticals announced that the U.S. Food and Drug Administration, FDA, has granted Fast Track designation for Kala‘s human mesenchymal stem cell secretome, MSC-S, therapy, KPI-012, for the treatment of persistent corneal epithelial defect, PCED, a rare and debilitating ocular condition. "There is a significant unmet need for patients suffering from PCED, which can lead to many complications and sequelae, including vision impairment, infection, corneal perforation and significant pain and discomfort. There are currently no approved pharmaceutical treatments for the majority of PCED patients, and KPI-012’s multifactorial mechanism of action is a potential solution to address all underlying etiologies of PCED," said Kim Brazzell, Ph.D., Head of R&D and Chief Medical Officer at Kala Pharmaceuticals. "We look forward to working with the Agency to efficiently advance KPI-012 through the development and review process to fulfill our greater mission of delivering a treatment to the roughly 100,000 patients in the U.S., and thousands more globally, suffering from PCED."