Kala Pharmaceuticals Reports the US FDA’s Acceptance of IND Application of KPI-012 for Persistent Corneal Epithelial Defect
Shots:
- The US FDA has accepted an IND application to initiate a P-IIb trial evaluating the safety & efficacy of 2 doses of KPI-012 ophthalmic solution vs vehicle for PCED
- Study plans to initiate enrolment of ~90 adult patients by Q1’23, with expected results in Q1’24. The 1EPs of the trial will be complete healing of the PCED as measured by corneal fluorescein staining
- The positive results will support the BLA submission to the US FDA. The company also plans to advance KPI-012 for partial LSCD & ocular manifestations of mod. to sev. Sjögren's and also plans to start the preclinical studies to assess the MSC-S platform’s potential utility for retinal degenerative diseases
Ref: PRNewswire | Image: Kala Pharmaceuticals
Related News :- Kala Pharmaceuticals' Eysuvis (loteprednol etabonate ophthalmic suspension) Receives US FDA's Approval for Dry Eye Disease
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