Descemet Stripping Only in Fuchs Endothelial Corneal Dystrophy: Results of a Randomized Clinical Trial of Topical Ripasudil and Directions for Future Innovation

Colby K, Kruse F, Kinoshita S (2026)

Publication Type: Journal article

Publication year: 2026

Journal

American Journal of Ophthalmology Elsevier

Book Volume: 290

Pages Range: 145-160

DOI: 10.1016/j.ajo.2026.06.014

Abstract

Purpose: To review history of Descemet stripping only (DSO) in Fuchs endothelial corneal dystrophy, describe the results of a clinical trial of topical ripasudil after DSO (K-321-201 study), and discuss future directions. Methods: A 1-year, phase 2, randomized, placebo-controlled multicenter clinical trial of two doses of K-321 (ripasudil) administered for 12 weeks after DSO surgery in Fuchs endothelial corneal dystrophy was performed. The primary endpoint, central corneal endothelial cell density (ECD) at 12 weeks after surgery, was determined by an independent reading center that was masked to study group assignment. Duration of corneal edema, need for medical or surgical rescue therapy, corneal thickness, and central ECD throughout the entire study period were also examined. Adverse events and exploratory endpoints were collected. Results: Sixty-five subjects were enrolled (21 in the QID group, 22 in the BID, and in the placebo group). Over 95% of subjects completed the trial. The QID group had a higher central ECD 12 weeks after DSO than the placebo group (531 ± 312 cells/mm2 vs 228 ± 298 cells/mm2, P = .0065). Corneal edema cleared in 17/21 (81.0%) of the QID group at 12 weeks, compared with 2/22 (9.1%) of the placebo group (P < .0001). Rescue was required in 2/21 (9.5%) subjects in the QID group and 6/22 (27.3%) subjects in the placebo group (P = .0092). Adverse events were mild and did not lead to discontinuation of treatment. Conclusions: Topical K-321 given QID improves DSO outcomes, as demonstrated by a higher ECD, more rapid resolution of corneal edema, and reduced failure rate. The medication was well-tolerated.

Authors with CRIS profile

Friedrich Kruse Lehrstuhl für Augenheilkunde

Involved external institutions

New York University (NYU) US United States (USA) (US) Kyoto Prefectural University of Medicine / 京都府立医科大学 JP Japan (JP)

How to cite

APA:

Colby, K., Kruse, F., & Kinoshita, S. (2026). Descemet Stripping Only in Fuchs Endothelial Corneal Dystrophy: Results of a Randomized Clinical Trial of Topical Ripasudil and Directions for Future Innovation. American Journal of Ophthalmology, 290, 145-160. https://doi.org/10.1016/j.ajo.2026.06.014

MLA:

Colby, Kathryn, Friedrich Kruse, and Shigeru Kinoshita. "Descemet Stripping Only in Fuchs Endothelial Corneal Dystrophy: Results of a Randomized Clinical Trial of Topical Ripasudil and Directions for Future Innovation." American Journal of Ophthalmology 290 (2026): 145-160.

BibTeX: Download