Long-Term Intraocular Pressure-Lowering Effects and Adverse Events of Ripasudil in Patients with Glaucoma or Ocular Hypertension over 24 Months

Abstract

Introduction: Glaucoma is a leading cause of irreversible blindness and ripasudil was the first Rho kinase inhibitor approved as antiglaucoma medication. Here we present the final analysis of the ROCK-J study, a large-scale post-marketing surveillance study to evaluate the long-term safety and effectiveness of ripasudil in Japanese patients with glaucoma or ocular hypertension in a real-word clinical setting. Methods: ROCK-J was a 24-month, prospective, open-label, observational study that included ripasudil-naı ¨ve patients with glaucoma or ocular hypertension who were initiating treatment with ripasudil according to the Japanese approved indication between June 1, 2015 and April 30, 2017. The primary safety endpoint was the incidence of adverse drug reactions (ADRs) (including blepharitis, plus assessment of its background factors); the primary efficacy endpoint was change in intraocular pressure (IOP) from baseline to 24 months. Results: A total of 3374 Japanese patients with glaucoma or ocular hypertension were evaluated for safety and 3178 for effectiveness of ripasudil over a mean 524.5-day observational period. Overall, 853 (25.3%) patients experienced adverse drug reactions; the most common were blepharitis (8.6%), conjunctival hyperemia (8.5%), and conjunctivitis (6.3%). Multivariate analyses demonstrated that patients were more likely to experience the ADR blepharitis with ripasudil treatment if they were female (hazard ratio [HR] 1.307; p = 0.040), had comorbid or a previous history of blepharitis (HR 2.178; p = 0.001), or had a history of allergy to pollen (HR 1.645; p = 0.003) or medication (HR 2.276; p \ 0.001). IOP decreased significantly from baseline with ripasudil; the leastsquares mean ± standard error change in IOP from baseline to 24 months was -2.6 ± 0.1 mmHg (p \ 0.001). Significant IOP changes were seen in four types of glaucoma, namely primary open-angle glaucoma, normaltension glaucoma, primary angle-closure glaucoma, and secondary glaucoma, and ocular hypertension. Conclusion: Ripasudil was safe and effective as an antiglaucoma medication with no new safety signals identified and significant reductions in

Evaluating the efficacy of Rho kinase inhibitor eye drops in the management of corneal edema: A single-center retrospective cohort study

“…[ 19 20 ] The drug has demonstrated consistent IOP reduction throughout the day and night and has been well-tolerated in multiple studies. [ 18 21 22 ]…”

Inhibidores RHO quinasa en el tratamiento del glaucoma de ángulo abierto.

“…Las diversas investigaciones han revelado reacciones adversas por la administración de medicamentos utilizados en la terapia farmacológica en el tratamiento de glaucoma de ángulo abierto. Tanihara et al (19), al evaluar la seguridad y eficacia de Ripasudil constataron reacciones adversas en el 8.6% de blefaritis, 8.5% de hiperemia conjuntival y en el 6.3% conjuntivitis, siendo el mayor riesgo de blefaritis con Ripasudil en mujeres.…”

“…Por el contrario, Tanihara et.al. (19) reporto que la blefaritis fue la reacción adversa más común informada y la razón más común para la interrupción del tratamiento con Ripasudil. Serle et al (37) documento que los efectos adversos tuvieron mayor incidencia en los pacientes a los cuales se administró Netarsudil de 2 veces al día.…”

“…En los Estados Unidos se estima que hay más de 3 millones de individuos y en Brasil constituyen más del 3,4% de la población mayor de 40 años (17,18). En Japón, más del 5% de la población mayor de 40 años padece esta enfermedad, según la investigación de Tanihara (19).…”

“…Tanihara et.al. (19) en su estudio sobre los efectos reductores de la presión intraocular a largo plazo y eventos adversos de Ripasudil en pacientes con glaucoma o hipertensión ocular durante 24 meses, la PIO descendió con Ripasudil de -2,6 ± 0,1 mmHg por lo que los pacientes alcanzaron una PIO media de 14,5 ± 4,2 mmHg. Las Reacciones adversas más frecuentes fueron 8.6% blefaritis, 8.5% hiperemia conjuntival, 6.3% conjuntivitis, prurito ocular 1,7%.…”