September 2016
Volume 57, Issue 12
Open Access
ARVO Annual Meeting Abstract  |   September 2016
Specific clinical features of intraocular pressure-lowering effect in ripasudil (K-115): insights from 52-week phase 3 study
Author Affiliations & Notes
  • Hidenobu Tanihara
    Department of Ophthalmology, Faculty of Life Sciences, Kumamoto University, Kumamoto, Japan
  • Toshihiro Inoue
    Department of Ophthalmology, Faculty of Life Sciences, Kumamoto University, Kumamoto, Japan
  • Tetsuya Yamamoto
    Department of Ophthalmology and Visual Science, Gifu University Graduate School of Medicine, Gifu, Japan
  • Yasuaki Kuwayama
    Fukushima Eye Clinic, Osaka, Japan
  • Haruki Abe
    Niigata University of Health and Welfare, Niigata, Japan
  • Atsuki Fukushima
    Department of Ophthalmology and Visual Science, Kochi Medical School, Kochi, Japan
  • Hideki Suganami
    Kowa Company, Ltd, Nagoya, Japan
  • Makoto Araie
    Kanto Central Hospital of the Mutual Aid Association of Public School Teachers, Tokyo, Japan
  • Footnotes
    Commercial Relationships   Hidenobu Tanihara, Alcon Japan (S), Kowa (C), MSD (C), Pfizer Japan (S), Santen Pharmaceutical (S), Senju Pharmaceutical (S); Toshihiro Inoue, None; Tetsuya Yamamoto, Alcon Japan (S), Kowa (C), Kowa (S), MSD (C), MSD (S), Otsuka Pharmaceutical (C), Otsuka Pharmaceutical (S), Pfizer Japan (S), Santen Pharmaceutical (S), Senju Pharmaceutical (S); Yasuaki Kuwayama, Alcon Japan (S), Bausch & Lomb Japan (C), Kowa (C), MSD (C), Otsuka Pharmaceutical (S), Pfizer Japan (S), Santen Pharmaceutical (S), Senju Pharmaceutical (S); Haruki Abe, Alcon Japan (S), Kowa (C), Pfizer Japan (S); Atsuki Fukushima, Alcon Japan (C), Alcon Japan (S), Kissei Pharmaceutical (S), Kowa (C), Kyowa Hakko Kirin (S), Mitsubishi Tanabe Pharma (S), Nidek (P), Novartis Pharma K.K. (S), Otsuka Pharmaceutical (S), Pfizer Japan (S), Santen Pharmaceutical (C), Santen Pharmaceutical (S), Senju Pharmaceutical (S); Hideki Suganami, Kowa (E); Makoto Araie, Alcon Japan (S), Allergan Japan (C), Bausch & Lomb Japan (C), Carl Zeiss Japan (S), Heidelberg Japan (C), JFC (S), Kowa (C), MSD (C), MSD (S), Nitten Pharmaceutical (S), Otsuka Pharmaceutical (S), Pfizer Japan (S), Santen Pharmaceutical (S), Senju Pharmaceutical (S), Topcon (C), Topcon (P)
  • Footnotes
    Support  This study was sponsored by Kowa Company, Ltd, Nagoya, Japan.
Investigative Ophthalmology & Visual Science September 2016, Vol.57, 3033. doi:
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      Hidenobu Tanihara, Toshihiro Inoue, Tetsuya Yamamoto, Yasuaki Kuwayama, Haruki Abe, Atsuki Fukushima, Hideki Suganami, Makoto Araie; Specific clinical features of intraocular pressure-lowering effect in ripasudil (K-115): insights from 52-week phase 3 study. Invest. Ophthalmol. Vis. Sci. 2016;57(12):3033.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : In eyes with open angle glaucoma, elevated intraocular pressure (IOP) is hypothesized to derive primarily from increased resistance to the conventional aqueous outflow. Rho kinase inhibitors directly modulate this target site, resulting in IOP reductions. The aim of this report was to identify specific clinical features in IOP-lowering response after treatment with ripasudil (K-115), a selective Rho kinase inhibitor, twice daily for 52 weeks, in patients with glaucoma and ocular hypertension (OHT).

Methods : This investigation was based on an additional analysis of the phase 3, prospective, open-label, multicenter clinical study of ripasudil. A total of 354 patients with primary open-angle glaucoma, OHT, or exfoliation glaucoma whose baseline IOP level was 15-35 mmHg, were subdivided into four cohorts; 0.4% ripasudil as monotherapy (n = 173) or its combination therapy with prostaglandin analogs, β-blockers, or fixed combination of prostaglandin analogs and β-blockers (n = 181). Changes in IOP in the first half (4-28 weeks) and the second half (32-52 weeks) of the study were compared.

Results : Ripasudil showed sustained IOP-lowering effects throughout 52 weeks. In monotherapy, the changes in IOP from baseline to the first and the second half period were -2.12 and -2.61 mmHg at trough with a difference of -0.49 mmHg (P < 0.001), and -3.23 and -3.81 mmHg at peak with a difference of -0.58 mmHg (P < 0.001), respectively. Similarly, the differences were observed in combination therapy (trough: -0.40 mmHg, P < 0.001; peak: -0.46 mmHg, P < 0.001). Furthermore, the reduction over the second half was even greater in the eyes with baseline IOP of 21 mmHg or higher in the monotherapy (trough, -0.91 mmHg; peak, -0.84 mmHg), and in the eyes with baseline IOP of 18 mmHg or higher in the combination therapy (trough, -0.64 mmHg; peak, -0.73 mmHg).

Conclusions : Long-term administration of 0.4% ripasudil revealed an additional IOP-lowering effect in the eyes with glaucoma or OHT, suggesting an attractive clinical feature which differentiates from other IOP-lowering medications.

This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.

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