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
Year: 2026
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
Abstract: 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. 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. 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. Netarsudil + latanoprost was superior to placebo + latanoprost in lowering elevated IOP in Japanese patients with POAG or OHT. No new safety signals were reported. Japan registry of clinical trials: jRCT2031210122. Glaucoma is often caused by an abnormal build-up of fluid in the eye. This raises pressure inside the eye (intraocular pressure), known as ocular hypertension (OHT). OHT can damage the optic nerve to the brain and lead to gradual vision loss. Primary open-angle glaucoma (POAG) occurs when the eye’s drainage channels become blocked. This stops fluid from leaving the eye, raising intraocular pressure. POAG and OHT can be treated with eye drops containing medicine, such as latanoprost or netarsudil, that reduce intraocular pressure. Individually, these medicines may not be enough to lower intraocular pressure to the necessary target; some people may need two or more medicines. This study looked at how well latanoprost and netarsudil work together to lower intraocular pressure in Japanese adults with POAG or OHT and above-normal intraocular pressure. Half of the participants were treated with latanoprost and netarsudil. The other half were treated with latanoprost and eye drops containing no medicine (placebo). After 1, 2 and 4 weeks of treatment, there was a bigger reduction in intraocular pressure with latanoprost and netarsudil than with latanoprost and placebo. Mild side effects occurred in 65% of the latanoprost and netarsudil group and in 21% of the latanoprost and placebo group. Reddening of the eye caused by enlarged blood vessels (known as conjunctival hyperaemia) was the most common side effect. Overall, latanoprost and netarsudil were better than latanoprost and placebo at lowering intraocular pressure. Side effects were more common with latanoprost and netarsudil than with latanoprost and placebo, but none were serious.
Source: Advances in Therapy
Author: Makoto Aihara
Institution: The University of Tokyo
Language: English
Subfield: Ophthalmology
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $4,790
Funder: Santen
OpenAlex ID: W7143922580