Kala stock rises on FDA fast track status for KPI-012 for rare eye disorder
Sarah Silbiger
- The U.S. Food and Drug Administration (FDA) granted fast track designation to Kala Pharmaceuticals' (NASDAQ:KALA) human mesenchymal stem cell secretome (MSC-S) therapy KPI-012 to treat persistent corneal epithelial defect (PCED), a rare and eye disorder.
- "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, head of R&D and chief medical officer, Kala.
- KPI-012 is being evaluated in a phase 2b trial to treat PCED. In March, the company reported safety data from the first group of two patients treated with a high dose of KPI-012 (3 U/mL).
- Kala expects to report topline safety and efficacy data in Q1 2024.
- PCED is a persistent non-healing corneal defect or wound which is refractory to conventional treatments. It is a rare disease with an estimated incidence in the U.S. of 100K cases per year, according to the company.
- KALA +2.35% to $17.44 premarket April 12