One-year clinical evaluation of 0.4% ripasudil (K-115) in patients with open-angle glaucoma and ocular hypertension.

Abstract

PURPOSE:

To investigate the intra-ocular pressure (IOP)-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 (OHT).

METHODS:

In this multicentre, prospective, open-label study, 388 patients with primary open-angle glaucoma, OHT or exfoliation glaucoma were enrolled and 354 of them were subdivided into four cohorts (monotherapy, 173; additive therapy to prostaglandin analogs, 62; β-blockers, 60; or fixed combination drugs, 59). The IOP reduction at trough and peak from baseline and adverse events was investigated.

RESULTS:

Ripasudil showed IOP-lowering effects over 52 weeks in all the analyses of monotherapy, additive therapy and both subgroups (baseline IOP ≥21 mmHg and <21 mmHg) of monotherapy. The mean IOP 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 (n = 264, 74.6%), blepharitis (n = 73, 20.6%) and allergic conjunctivitis (n = 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.

CONCLUSION:

Fifty-two week administration of 0.4% ripasudil revealed IOP-lowering effects and an acceptable safety profile when administered as monotherapy or as additive therapy, in patients with open-angle glaucoma or OHT.

• Authors: Hidenobu Tanihara, Toshihiro Inoue, Tetsuya Yamamoto, Yasuaki Kuwayama, Haruki Abe, Atsuki Fukushima, Hideki Suganami, Makoto Araie, K-115 Clinical Study Group
• Journal: Acta ophthalmologica (Acta Ophthalmol) Vol. 94 Issue 1 Pg. e26-34 (Feb 2016) ISSN: 1755-3768 [Electronic] England
• PMID: 26338317 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
• Copyright: © 2015 Acta Ophthalmologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.

Chemical References

• Adrenergic beta-Antagonists
• Antihypertensive Agents
• Drug Combinations
• Isoquinolines
• K-115
• Ophthalmic Solutions
• Sulfonamides
• rho-Associated Kinases

Topics

• Adrenergic beta-Antagonists (therapeutic use)
• Aged
• Antihypertensive Agents (adverse effects, therapeutic use)
• Drug Combinations
• Female
• Follow-Up Studies
• Glaucoma, Open-Angle (drug therapy)
• Humans
• Intraocular Pressure (drug effects)
• Isoquinolines (adverse effects, therapeutic use)
• Male
• Middle Aged
• Ocular Hypertension (drug therapy)
• Ophthalmic Solutions
• Prospective Studies
• Sulfonamides (adverse effects, therapeutic use)
• Tonometry, Ocular
• rho-Associated Kinases (antagonists & inhibitors)