The Food and Drug Administration (FDA) has granted Fast Track designation to KPI-012 for the treatment of persistent corneal epithelial defect (PCED).
PCED is a rare, non-healing corneal defect or wound that is refractory to conventional treatments. The disease can have various etiologies, including neurotrophic keratitis, surgical epithelial debridement, microbial/viral keratitis, corneal transplant, limbal stem cell deficiency and mechanical and chemical trauma.
KPI-012 is a topically dosed ophthalmic therapy designed using the Company’s human mesenchymal stem cell secretome (MSC-S) platform. KPI-012 contains human-derived biofactors (eg, growth factors, protease inhibitors, matrix proteins, neurotrophic factors) to correct the impaired corneal healing. The Company believes that the investigational drug could potentially treat PCED across all its various etiologies.
The Company is currently investigating the efficacy and safety of KPI-012 ophthalmic solution in adults with PCED in the phase 2b CHASE trial (ClinicalTrials.gov Identifier: NCT05727878).
“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, PhD, Head of R&D and Chief Medical Officer at Kala Pharmaceuticals.
Kala Pharmaceuticals receives FDA Fast Track designation for KPI-012, a human MSC-S Therapy for persistent corneal epithelial defect. News release. Kala Pharmaceuticals. Accessed April 12, 2023. https://www.globenewswire.com/news-release/2023/04/12/2645285/0/en/Kala-Pharmaceuticals-Receives-FDA-Fast-Track-Designation-for-KPI-012-a-Human-MSC-S-Therapy-for-Persistent-Corneal-Epithelial-Defect.html.