Efficacy and Safety Study of Netarsudil 0.02% Ophthalmic Solution Compared to Ripasudil Hydrochloride Hydrate 0.4% Ophthalmic Solution in Japanese Subjects With Primary Open Angle Glaucoma or Ocular Hypertension

NCT04620135 ↗

Phase 3 Completed 245 enrolled Aerie Pharmaceuticals

RandomizedParallel-groupDouble-blindTreatment

Summary

A Phase 3 Study Comparing the Efficacy and Safety of Netarsudil Ophthalmic Solution 0.02% QD to Ripasudil Hydrochloride Hydrate Ophthalmic Solution 0.4% BID, for Treatment of Primary Open-Angle Glaucoma or Ocular Hypertension Over A 4-Week Period.

Timeline

Start: 2020-11-30
Primary completion: 2021-07-09
Completion: 2021-07-30

Outcome

Met primary endpoint

paper demonstrating the superiority of netarsudil 0.02% QD over ripasudil 0.4% BID by a margin of - 1.74 mmHg (p < 0.0001). PMID 37603205 ↗

registry The least squares (LS) mean difference -1.74 (95% CI -2.17 to -1.31); NCT04620135 ↗

release “endpoint of intraocular pressure (IOP) at week 4, taking netarsudil 0.02% once daily was shown to be superior to ripasudil 0.4% twice daily.” santen.com ↗

Publications

Araie M, Sugiyama K, Aso K, Kanemoto K, Iwata R, Hollander DA, Senchyna M, Kopczynski CC. Phase 3 Clinical Trial Comparing the Safety and Efficacy of Netarsudil to Ripasudil in Patients with Primary Open-Angle Glaucoma or Ocular Hypertension: Japan Rho Kinase Elevated Intraocular Pressure Treatment Trial (J-ROCKET). Adv Ther. 2023 Oct;40(10):4639-4656. doi: 10.1007/s12325-023-02550-w. Epub 2023 Aug 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Netarsudil	Small molecule	0.02 %	Topical
Comparator	Ripasudil	Small molecule	0.4 %	Topical