Safety and Efficacy of Ripasudil in Japanese Patients with Glaucoma or Ocular Hypertension: 3-month Interim Analysis of ROCK-J, a Post-Marketing Surveillance Study

Abstract

IntroductionTo evaluate the safety and intraocular pressure (IOP)-lowering effects of a ripasudil 0.4% ophthalmic solution in Japanese patients with glaucoma and ocular hypertension (OH) as a post-marketing surveillance.MethodsThis was a 2-year prospective observational study in patients with glaucoma or OH who had not previously received ripasudil. Patients registered in the study using a central internet-based system from June 1, 2015 to April 30, 2017. Data on adverse drug reactions (ADRs) and IOP were collected and analysed from the first 3 months of ripasudil treatment.ResultsOf the 3058 patients in the safety analysis set, 3016 had IOP data and were included in the efficacy analysis. ADRs were seen in 244 (8.0%) of the 3058 patients. IOP decreased significantly in patients with primary open-angle glaucoma (− 2.9 ± 4.2 mmHg; p < 0.001), normal tension glaucoma (− 1.7 ± 2.4 mmHg; p < 0.001), primary angle-closure glaucoma (− 3.9 ± 5.3 mmHg; p < 0.001), and OH (− 3.8 ± 5.8 mmHg; p < 0.001). Significant IOP reduction was also noted in exfoliation glaucoma (− 3.0 ± 5.5 mmHg; p < 0.001), uveitis-associated glaucoma (− 4.7 ± 7.2 mmHg; p < 0.001) and steroid glaucoma (− 5.5 ± 6.0 mmHg; p < 0.001), but not for neovascular glaucoma (− 2.8 ± 12.1 mmHg; p = 0.669).ConclusionRipasudil was safe and effective in the treatment of glaucoma and OH in Japanese patients, with a low incidence of ADRs or treatment discontinuation, and reduced IOP after 3 months of treatment.FundingKowa Company, Ltd., Tokyo, Japan.

Safety and efficacy of ripasudil in Japanese patients with glaucoma or ocular hypertension: 12-month interim analysis of ROCK-J, a post-marketing surveillance study

“…A long-term, large-scale post-marketing surveillance (PMS) study is being conducted in Japan to evaluate the safety and efficacy profile of ripasudil in the real-word clinical setting. Three-month interim results have been reported previously, and showed the safety and efficacy of ripasudil in reducing IOP in patients with various subtypes of glaucoma [18]. Because of the potential risk of allergy during long-term treatment with ripasudil, it is important to establish whether the short-term results seen in the 3-month analysis of the PMS study were maintained during long-term therapy.…”

One-Year Efficacy and Safety Assessment of Ripasudil, a Rho Kinase Inhibitor, in an Addition to or Replacing Existing Treatment Regimens: A Retrospective Study

“…The discontinuation rate due to adverse effects was 38.3% in this study (Table 3), which was similar to the rates of 8.0%-40.7% reported in previous studies. 22,25,26,28 Blepharitis was the most commonly observed adverse effect that led to termination of ripasudil use. 25 However, the incidence of blepharitis in this study was 15.0%, which was lower than the rates (20.6%-25.2%) reported in previous studies.…”

“…In the (a) Addition-Survival group, higher IOP before ripasudil administration was associated with a greater reduction in IOP, which supports previous reports showing that high baseline IOP levels are associated with greater IOP reduction after instillation of PGs [41][42][43] or ripasudil. 4,22,24 In the (c) Switching-Survival group, the IOP reduction rate may be high in cases without a glaucoma surgical history. This is because after filtration surgery, the main outflow pathway of the aqueous humor changes from the TM to the conjunctival filtration bleb through the scleral window.…”

“…Previous studies showed that ROCK inhibitors are effective for exfoliation glaucoma (XFG). 22,23,27 XFG is an SG, in These factors, which showed significant probability of lower than 0.5 in univariate regression, were included in multiple stepwise regression analysis as explanatory variables. Values in bold are P < 0.5 in univariate regression analysis, and are statistically significant (P < 0.05) in multiple regression analysis.…”

“…[6][7][8][9][10][11] Ripasudil has a different IOP-lowering mechanism from the existing antiglaucoma instillations; therefore, it is expected to be used in combination with conventional antiglaucoma ophthalmic solutions. Although many studies have already reported the short-term IOP reduction and adverse effects associated with ripasudil treatment, [12][13][14][15][16][17][18][19][20][21][22][23][24][25][26][27] the long-term efficacy of ripasudil over more than 1 year has been addressed by only a few studies. 28,29 In addition, relatively few studies have evaluated the clinical factors affecting IOP reduction in cases wherein ripasudil was an addition to or a switch from the existing antiglaucoma instillations.…”