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
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