The Additive Effect of ROCK Inhibitor on Prostaglandin-Treated Japanese Patients with Glaucoma Indicating 15 mmHg and Under: ROCK U-15

Adv Ther. 2021 Jul;38(7):3760-3770. doi: 10.1007/s12325-021-01775-x. Epub 2021 May 24.

Abstract

Introduction: We aimed to evaluate the additional effects and safety of a Rho-associated protein kinase (ROCK) inhibitor, ripasudil hydrochloride hydrate, in Japanese patients with primary open-angle glaucoma (POAG) with an intraocular pressure (IOP) of at most 15 mmHg undergoing prostaglandin F2α (FP) receptor agonist monotherapy (FP monotherapy).

Methods: In this prospective observational study, 30 Japanese patients with POAG and IOP of at most 15 mmHg (mean age 59.4 years; 10 men) who were undergoing FP monotherapy in both eyes were administered an additional dose of ripasudil hydrochloride hydrate (GLANATEC ophthalmic solution 0.4%: ripasudil) in one eye. The following factors were investigated at 1 and 3 months after the initiation of ripasudil treatment: (1) magnitude of change in IOP between the treated and contralateral untreated eyes, (2) number of treated eyes showing 20% and 30% IOP reduction, (3) IOP difference between treated and contralateral untreated eyes, and (4) safety during the treatment period. Both (1) and (3) were analyzed using the mixed-effect model for repeated measurements.

Results: The treated eyes showed significant reduction in IOP at 1 month (- 1.92 mmHg, P < 0.001) and 3 months (- 1.81 mmHg, P < 0.001). In contrast, contralateral untreated eyes did not show IOP reduction at 1 month (0.53 mmHg, P = 0.016) and 3 months (0.38 mmHg, P = 0.15). IOP reduction of - 20% and - 30% was achieved in 9 (30%) and 3 (10%) treated eyes, respectively. There were significant differences in IOP between the treated and contralateral untreated eyes at 1 month (- 2.46 mmHg, P < 0.001) and 3 months (- 2.20 mmHg, P < 0.001). Two patients experienced local adverse events (facial edema, one patient at week 1; blepharitis, one patient at 1 month); they recovered quickly after stopping ripasudil administration.

Conclusion: In patients with POAG with an IOP of at most 15 mmHg undergoing FP monotherapy, the addition of ripasudil resulted in significant IOP lowering at 1 and 3 months. Ripasudil could be used to enhance the outcome of FP monotherapy.

Trial registration: Registered UMIN ID: UMIN000030742.

Keywords: FP receptor agonist; Intraocular pressure; Japanese; Open-angle glaucoma; Ripasudil.

Publication types

  • Observational Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Antihypertensive Agents* / therapeutic use
  • Glaucoma* / drug therapy
  • Glaucoma, Open-Angle* / drug therapy
  • Humans
  • Intraocular Pressure
  • Japan
  • Male
  • Middle Aged
  • Prostaglandins / therapeutic use
  • Treatment Outcome
  • rho-Associated Kinases / antagonists & inhibitors*

Substances

  • Antihypertensive Agents
  • Prostaglandins
  • rho-Associated Kinases