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Introduction <p>This prospective, phase&#xa0;III, randomised, multicentre, double-masked study (jRCT2031210122) assessed the intraocular pressure (IOP)-lowering efficacy, tolerability and superiority of netarsudil 0.02% + concomitant latanoprost 0.005% to placebo + latanoprost in Japanese participants with primary open-angle glaucoma (POAG) or ocular hypertension (OHT) who have inadequate IOP reduction with latanoprost monotherapy.</p> Methods <p>Participants received latanoprost once daily for 6&#xa0;weeks. Eligible participants (<i>n</i> = 246) with POAG (<i>n</i> = 165) or OHT (<i>n</i> = 81) were randomised (1:1) to netarsudil + latanoprost (<i>n</i> = 122) or placebo + latanoprost (<i>n</i> = 124) for 4&#xa0;weeks. Primary endpoint was mean diurnal (MD) IOP at week&#xa0;4, with superiority demonstrated if the between-group difference in least squares mean MD IOP was &lt; 0 and <i>p</i> &lt; 0.05. Secondary endpoints included MD IOP at weeks&#xa0;1 and 2. Adverse events (AEs) were recorded.</p> Results <p>At week&#xa0;4, MD IOP (standard error) was 15.29 (0.17) versus 17.65&#xa0;(0.17) mmHg with netarsudil + latanoprost versus placebo + latanoprost, respectively [difference, − 2.36 (<i>p</i> &lt; 0.0001)]. The differences at weeks&#xa0;1 and 2 between netarsudil + latanoprost and placebo + latanoprost were − 2.47 and − 2.41 (<i>p</i> &lt; 0.0001), respectively. At each visit, netarsudil + latanoprost significantly reduced MD IOP versus placebo + latanoprost (<i>p</i> &lt; 0.0001). Of those receiving netarsudil + latanoprost, 64.8% reported AEs versus 21.0% receiving placebo + latanoprost. Conjunctival hyperaemia was the most reported AE in both groups (53.3% vs. 6.5%). No serious AEs were reported.</p> Conclusion <p>Netarsudil + latanoprost was superior to placebo + latanoprost in lowering elevated IOP in Japanese patients with POAG or OHT. No new safety signals were reported.</p> Trial Registration <p>Japan registry of clinical trials: jRCT2031210122.</p>

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Phase III Prospective Randomised Study of Netarsudil and Concomitant Latanoprost Efficacy and Safety for Primary Open-Angle Glaucoma or Ocular Hypertension in Japan: J-ROCKET-2

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  • 发表日期：

    2026年3月31日

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  • Makoto Aihara

摘要

Introduction

This prospective, phase III, randomised, multicentre, double-masked study (jRCT2031210122) assessed the intraocular pressure (IOP)-lowering efficacy, tolerability and superiority of netarsudil 0.02% + concomitant latanoprost 0.005% to placebo + latanoprost in Japanese participants with primary open-angle glaucoma (POAG) or ocular hypertension (OHT) who have inadequate IOP reduction with latanoprost monotherapy.

Methods

Participants received latanoprost once daily for 6 weeks. Eligible participants (n = 246) with POAG (n = 165) or OHT (n = 81) were randomised (1:1) to netarsudil + latanoprost (n = 122) or placebo + latanoprost (n = 124) for 4 weeks. Primary endpoint was mean diurnal (MD) IOP at week 4, with superiority demonstrated if the between-group difference in least squares mean MD IOP was < 0 and p < 0.05. Secondary endpoints included MD IOP at weeks 1 and 2. Adverse events (AEs) were recorded.

Results

At week 4, MD IOP (standard error) was 15.29 (0.17) versus 17.65 (0.17) mmHg with netarsudil + latanoprost versus placebo + latanoprost, respectively [difference, − 2.36 (p < 0.0001)]. The differences at weeks 1 and 2 between netarsudil + latanoprost and placebo + latanoprost were − 2.47 and − 2.41 (p < 0.0001), respectively. At each visit, netarsudil + latanoprost significantly reduced MD IOP versus placebo + latanoprost (p < 0.0001). Of those receiving netarsudil + latanoprost, 64.8% reported AEs versus 21.0% receiving placebo + latanoprost. Conjunctival hyperaemia was the most reported AE in both groups (53.3% vs. 6.5%). No serious AEs were reported.

Conclusion

Netarsudil + latanoprost was superior to placebo + latanoprost in lowering elevated IOP in Japanese patients with POAG or OHT. No new safety signals were reported.

Trial Registration

Japan registry of clinical trials: jRCT2031210122.