Kala Pharmaceuticals Receives FDA Fast Track Designation for KPI-012, a Human MSC-S Therapy for Persistent Corneal Epithelial Defect
Retrieved on:
Wednesday, April 12, 2023
The purpose of this designation is to help speed development of new drugs, making them available to the patient more quickly.
Key Points:
- The purpose of this designation is to help speed development of new drugs, making them available to the patient more quickly.
- A company with a therapeutic candidate that receives Fast Track designation may be eligible for more frequent interactions with the FDA to discuss the product development plan.
- Therapeutic candidates with Fast Track designation may also be eligible for priority review and accelerated approval if supported by clinical data.
- In February 2023, Kala dosed the first patient in its CHASE (Corneal Healing After SEcretome therapy) Phase 2b trial evaluating KPI-012 for the treatment of PCED.