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

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2024年3月2日

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Hidenobu Tanihara,
Tetsuya Yamamoto,
Makoto Aihara,
Noriko Koizumi,
Atsuki Fukushima,
Koji Kawakita,
Satoshi Kojima,
Toka Nakamura,
Hideki Suganami,
Yoshitsugu Tagawa,
Hiroki Watanabe,
Kiyoshi Shimizu,
Miki Iwasaki,
Sakae Matsuzaki,
Hiroko Ueda,
Ryoko Okayama,
Osamu Matsuoka,
Setsuko Hashida,
Sachi Amaki Kobayashi,
Motohiro Kiyosawa,
Yuko Asai,
Toru Nakajima,
Yuzuru Yoshimura,
Takao Sakai,
Ryoji Nomura,
Satoshi Inoue,
Ken Hayashi,
Junko Watanabe,
Hidehito Kawabata,
Tomoyuki Muramatsu,
Mikki Arai,
Masayoshi Migita

摘要

Purpose

To evaluate the long-term efficacy and safety of ripasudil-brimonidine fixed-dose combination (RBFC), a new intraocular pressure (IOP)-lowering medication for glaucoma and ocular hypertension (OHT).

Methods

This prospective, multicentre (23 sites in Japan), open-label study enrolled patients with primary open-angle glaucoma (POAG), OHT or exfoliative glaucoma and assigned them 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). After a ≥ 4-week screening period, eligible patients received twice-daily RBFC for 52 weeks in addition to the treatments they were already receiving. Efficacy was assessed by change in IOP from baseline through week 52. Adverse events and adverse drug reactions (ADRs) were monitored throughout.

Results

In total, 179 patients from Cohort 1 (n = 48), Cohort 2 (n = 44), Cohort 3 (n = 41) and Cohort 4 (n = 46) entered the RBFC treatment period. For all cohorts, mean IOP was significantly reduced at 11:00 (2 h after instillation of RBFC) through week 52 with the changes from baseline at week 52 of − 2.7 to − 4.1 mmHg across cohorts; all p < 0.001. Common ADRs were conjunctival hyperaemia (58%), allergic conjunctivitis (18%) and blepharitis (17%), most of which were mild in severity.

Conclusion

These data demonstrated the long-term efficacy and safety of RBFC, both alone and in combination with other anti-glaucoma agents. RBFC may offer a new treatment option for the long-term management of glaucoma and OHT.

Trial registration

Japan Registry of Clinical Trials Identifier: jRCT2080225063.

Date of registration

17 February 2020.