Descemet Stripping Only in Fuchs Endothelial Corneal Dystrophy: Results of a Randomized Clinical Trial of Topical Ripasudil and Directions for Future Innovation - PubMed
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- #Descemet Stripping Only
- #Ripasudil Clinical Trial
- #Fuchs Endothelial Corneal Dystrophy
- Descemet Stripping Only (DSO) surgery for Fuchs Endothelial Corneal Dystrophy (FECD) was tested in a phase 2 clinical trial.
- The trial assessed topical ripasudil (K-321) given four times daily (QID) or twice daily (BID) versus placebo after DSO over 12 weeks.
- Primary endpoint: central corneal endothelial cell density (ECD) at 12 weeks was significantly higher in the QID group compared to placebo (531±312 cells/mm² vs. 228±298 cells/mm², p=0.0065).
- Corneal edema resolved faster in the QID group (81.0%) than placebo (9.1%) at 12 weeks (p<0.0001), and rescue therapy was needed less often (9.5% vs. 27.3%, p=0.0092).
- Treatment was well-tolerated with only mild adverse events and no discontinuations, suggesting ripasudil improves DSO outcomes with higher ECD, quicker edema clearance, and lower failure rates.
- The study outlines future innovation directions based on these results for FECD treatment.