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

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.