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Editors Selection IGR 17-4

Medical Treatment: Efficacy and safety of a fixed RKI-brimonidine combination

Comment by Kaweh Mansouri on:

117152 Long-term intraocular pressure-lowering efficacy and safety of ripasudil-brimonidine fixed-dose combination for glaucoma and ocular hypertension: a multicentre, open-label, phase 3 study, Tanihara H; Yamamoto T; Aihara M et al., Graefe's Archive for Clinical and Experimental Ophthalmology, 2024; 262: 2579-2591

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Tanihara et al. report the results of a multicenter, open-label, phase-3 study in Japanese patients with glaucoma (POAG and PEXG) or OHT, designed to evaluate the long-term (52-week) efficacy and safety of ripasudil-brimonidine fixed-dose combination (RBFC), both alone and as a concomitant medication. Previously, two phase-3 studies had demonstrated the IOP-lowering efficacy of RBFC over eight weeks and found that patients receiving RBFC had significantly greater reductions in IOP than those receiving ripasudil or brimonidine alone. Patients were assigned to one of four combination therapy cohorts, based on previous treatment(s) received: prostaglandin (PG) analogue (Cohort 1); PG analogue and beta-adrenoceptor blocker (β-blocker) (Cohort 2); PG analogue, β-blocker and carbonic anhydrase inhibitor (Cohort 3); or other/no treatment (Cohort 4), in total 179 patients.

Despite high rates of conjunctival hyperemia, ROCK inhibitors are an important addition to the glaucoma treatment armamentarium

For all cohorts, mean IOP was significantly reduced at week 52 with the changes from baseline of −2.7 to −4.1 mmHg across cohorts. Subgroup analyses showed that RBFC had stable IOP-lowering effects across patient demographics and clinical characteristics. Common adverse effects were conjunctival hyperaemia (58%), allergic conjunctivitis (18%) and blepharitis (17%), most of which were mild in severity.

This is a well-conducted and impactful study on the first topical fixed-dose combination treatment for glaucoma that combines a rho kinase (ROCK) inhibitor with an α2-agonist. It demonstrates that, despite high rates of conjunctival hyperemia, ROCK inhibitors are an important addition to the glaucoma treatment armamentarium.

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