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KPI-012 is a novel, human bone marrow-derived mesenchymal stem cell (MSC) secretome therapy in development for the treatment of persistent corneal epithelial defect (PCED), a rare and serious ocular condition characterized by impaired or non-healing corneal wounds. The drug is formulated as an ophthalmic solution and administered topically. Its mechanism of action is multifactorial, leveraging a complex mixture of human-derived biofactors—including growth factors, protease inhibitors, matrix proteins, and neurotrophic factors—to address the underlying causes of impaired corneal healing across various etiologies such as neurotrophic keratitis, surgical debridement, microbial/viral keratitis, limbal stem cell deficiency, trauma, and more. KPI-012 aims to restore balance in key biomolecules involved in wound healing processes like proliferation and extracellular matrix remodeling. It is being developed by Kala Pharmaceuticals and has received FDA Fast Track designation for PCED[2][3][5][8].
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