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

Abstract

Purpose: To evaluate efficacy and safety of ripasudil for 1 year in addition to or replacing existing treatment regimens. Methods: We retrospectively reviewed the medical records for 128 eyes of 128 glaucoma patients who were prescribed ripasudil as an addition to or a switch from their preexisting antiglaucoma instillations. We investigated the rate and factors for discontinuation and intraocular pressure (IOP) reduction. Results: Almost half of the patients (60 eyes) discontinued ripasudil treatment before the 1 year mark, while remaining patients completed the treatment. The lack of efficacy and development of adverse effects were significantly correlated with discontinuation (P < 0.001) in the Cox proportional hazards model. In the Kaplan-Meier curve, adverse effects occurred in earlier phase and almost 60% dropped out within 3 months after ripasudil administration. However, adverse effects also occurred randomly throughout the study period. In patients who continued ripasudil, the mean IOPs (mmHg) at baseline, 6 and 12 months after treatment were 17.7-5.1, 14.6-5.0, and 14.8-3.8 in the Addition group, and 17.8-4.1, 15.4-3.2, and 15.4-5.0 in the Switch group, respectively (all P values <0.05). Conclusions: Almost half of the patients discontinued ripasudil owing to the lack of efficacy and the generation of adverse effects within the 1 year. In the remaining half, the addition and switching of ripasudil to the existing glaucoma treatment effectively reduced IOP for 1 year.

Study protocol for a multicentre, open-label, single-arm phase I/II trial to evaluate the safety and efficacy of ripasudil 0.4% eye drops for retinopathy of prematurity

“…The primary endpoint of this trial is safety. While the safety of ripasudil has been documented in adults, [14][15][16] it is not well evaluated in preterm infants. We are concerned about the occurrence of possible ADRs as described below.…”

“…The long-term safety of ripasudil eye drops in adults has also been examined in several studies and there have been no reports of serious adverse events (SAEs). [14][15][16] Eye drop therapy is less invasive compared with the existing treatment options such as laser photocoagulation (LPC) and intravitreal injection of anti-VEGF agents (anti-VEGF therapy). [17][18][19] This facilitates early intervention, which is a major advantage of the eye drop therapy.…”