Beschreibung:
<jats:title>Abstract</jats:title><jats:sec><jats:title>Purpose</jats:title><jats:p>To investigate the intra‐ocular pressure (<jats:styled-content style="fixed-case">IOP</jats:styled-content>)‐lowering effects and safety of 0.4% ripasudil (K‐115), a Rho kinase inhibitor, twice daily for 52 weeks, in patients with open‐angle glaucoma or ocular hypertension (<jats:styled-content style="fixed-case">OHT</jats:styled-content>).</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>In this multicentre, prospective, open‐label study, 388 patients with primary open‐angle glaucoma, <jats:styled-content style="fixed-case">OHT</jats:styled-content> or exfoliation glaucoma were enrolled and 354 of them were subdivided into four cohorts (monotherapy, 173; additive therapy to prostaglandin analogs, 62; <jats:italic>β</jats:italic>‐blockers, 60; or fixed combination drugs, 59). The <jats:styled-content style="fixed-case">IOP</jats:styled-content> reduction at trough and peak from baseline and adverse events was investigated.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>Ripasudil showed <jats:styled-content style="fixed-case">IOP</jats:styled-content>‐lowering effects over 52 weeks in all the analyses of monotherapy, additive therapy and both subgroups (baseline <jats:styled-content style="fixed-case">IOP</jats:styled-content> ≥21 mmHg and <21 mmHg) of monotherapy. The mean <jats:styled-content style="fixed-case">IOP</jats:styled-content> reductions at trough and peak at week 52 were −2.6 and −3.7 mmHg for monotherapy, and −1.4 and −2.4, −2.2 and −3.0, and −1.7 and −1.7 mmHg, respectively, for additive therapy described above. The most frequently observed adverse events were conjunctival hyperaemia (<jats:italic>n</jats:italic> = 264, 74.6%), blepharitis (<jats:italic>n</jats:italic> = 73, 20.6%) and allergic conjunctivitis (<jats:italic>n</jats:italic> = 61, 17.2%). Most of the conjunctival hyperaemia findings were mild (97.0%), transient and resolved spontaneously (78.0%). Although 51 patients discontinued from the study due to blepharitis and/or allergic conjunctivitis (blepharitis, 28; allergic conjunctivitis, 17; both, 6), all the events resolved with or without treatment after the discontinuation of ripasudil administration.</jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p>Fifty‐two week administration of 0.4% ripasudil revealed <jats:styled-content style="fixed-case">IOP</jats:styled-content>‐lowering effects and an acceptable safety profile when administered as monotherapy or as additive therapy, in patients with open‐angle glaucoma or <jats:styled-content style="fixed-case">OHT</jats:styled-content>.</jats:p></jats:sec>