Safety and Efficacy of Long-Term Ripasudil 0.4% Instillation for the Reduction of Intraocular Pressure in Japanese Open-Angle Glaucoma Patients.

Abstract

Purpose: Rho-associated kinase-inhibitor ripasudil 0.4% eye drops are reportedly effective for the reduction of intraocular pressure (IOP) in glaucoma patients. However, the previous studies investigated the efficacy of IOP reduction for only about 1 year. Here, we evaluated the safety and efficacy of long-term ripasudil instillation in Japanese open-angle glaucoma (OAG) patients. Methods: This study involved 312 eyes of 312 Japanese OAG patients newly initiated with ripasudil treatment at Kyoto Prefectural University of Medicine and Oike-Ikeda Eye Clinic, Kyoto, Japan. In all patients, adverse events leading to discontinuation of ripasudil treatment were investigated. Of the 312 patients, 129 patients able to continue ripasudil administration for over 12-months post-treatment initiation were enrolled to investigate the long-term efficacy. IOP data at 0-, 1-, 3-, 6-, 12-, 18-, and 24-months post initiation of continuous ripasudil use were obtained, and the IOP values at each time point were then compared. The first period (from 1-6 months) and second period (from 12-24 months) IOP data were also compared based on the mixed model. Results: IOP at each time-point post-treatment initiation was significantly reduced compared with that at pre initiation (P < 0.05). Differences in IOP between the first and second periods of the study were not statistically significant (P = 0.058). Adverse events leading to discontinuation of treatment included blepharitis (15.7%) and conjunctival hyperemia (9.0%). Conclusions: We found that in Japanese OAG patients, 24-month ripasudil eye drop instillation is both safe and effective for lowering IOP and that blepharitis is the primary adverse event for discontinuation of use.

• Authors: Yuko Maruyama, Yoko Ikeda, Kazuhiko Mori, Kengo Yoshii, Morio Ueno, Chie Sotozono, Shigeru Kinoshita
• Journal: Journal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeutics (J Ocul Pharmacol Ther) Vol. 36 Issue 4 Pg. 229-233 (05 2020) ISSN: 1557-7732 [Electronic] United States
• PMID: 32175792 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Isoquinolines
• K-115
• Ophthalmic Solutions
• Sulfonamides
• rho-Associated Kinases

Topics

• Aged
• Blepharitis (chemically induced)
• Conjunctival Diseases (pathology)
• Female
• Glaucoma, Open-Angle (drug therapy, physiopathology)
• Humans
• Hyperemia (chemically induced)
• Intraocular Pressure (drug effects)
• Isoquinolines (administration & dosage, adverse effects, therapeutic use)
• Japan (epidemiology)
• Male
• Middle Aged
• Ophthalmic Solutions (administration & dosage, adverse effects, therapeutic use)
• Retrospective Studies
• Safety
• Sulfonamides (administration & dosage, adverse effects, therapeutic use)
• Treatment Outcome
• rho-Associated Kinases (antagonists & inhibitors)