Pharma Focus Asia

Kala Pharmaceuticals Receives FDA Fast Track Designation for KPI-012

Thursday, April 13, 2023

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).

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. The fast track designation helps to speed development of new drugs, making them available to the patient more quickly.

Based on a multifactorial mechanism of action and preclinical and clinical data generated to-date, it is believed that KPI-012 represents a significant advancement in the treatment of PCED and will become the first approved treatment for PCED across all its various etiologies.

There is a significant unmet need for patients suffering from PCED, leading to many complications and sequelae, including vision impairment, infection, corneal perforation and significant pain and discomfort.

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.

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