Abstract | INTRODUCTION: A clinical trial evaluated ocular hypotensive efficacy and safety of netarsudil 0.02% once daily (QD) relative to ripasudil 0.4% twice daily (BID). METHODS: This was a single-masked, randomized, phase 3, superiority study. Japanese patients were randomized to either the netarsudil 0.02% group or the ripasudil 0.4% group in a 1:1 ratio and treated for 4 weeks. The primary efficacy variable was mean diurnal intraocular pressure (IOP) (average of diurnal time points at 09:00, 11:00, and 16:00) at Week 4. RESULTS: A total of 245 patients were included in the primary analysis. At Week 4, least squares (LS) mean of diurnal IOP adjusted for baseline was 15.96 and 17.71 mmHg in the netarsudil 0.02% and ripasudil 0.4% groups, respectively, demonstrating the superiority of netarsudil 0.02% QD over ripasudil 0.4% BID by a margin of - 1.74 mmHg (p < 0.0001). Mean reduction from baseline in mean diurnal IOP at Week 4 was 4.65 and 2.98 mmHg, respectively. Adverse events (AEs) occurred less frequently in netarsudil 0.02% than in ripasudil 0.4%, with the incidence of ocular AEs being 59.8% and 66.7%, respectively. The most frequently reported AE was conjunctival hyperemia in both groups, with an incidence of 54.9% and 62.6%, respectively. No serious eye-related AEs were reported. CONCLUSION: TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT04620135.
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Authors | Makoto Araie, Kazuhisa Sugiyama, Kenji Aso, Koji Kanemoto, Ryo Iwata, David A Hollander, Michelle Senchyna, Casey C Kopczynski |
Journal | Advances in therapy
(Adv Ther)
Vol. 40
Issue 10
Pg. 4639-4656
(10 2023)
ISSN: 1865-8652 [Electronic] United States |
PMID | 37603205
(Publication Type: Randomized Controlled Trial, Clinical Trial, Phase III, Journal Article, Research Support, Non-U.S. Gov't)
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Copyright | © 2023. The Author(s). |
Chemical References |
- K-115
- netarsudil
- rho-Associated Kinases
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Topics |
- Humans
- Intraocular Pressure
- rho-Associated Kinases
- Glaucoma, Open-Angle
(drug therapy)
- Japan
- Ocular Hypertension
(drug therapy)
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