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Intraocular pressure-lowering effect of omidenepag isopropyl in latanoprost non-/low-responder patients with primary open-angle glaucoma or ocular hypertension: the FUJI study

  • Clinical Investigation
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Japanese Journal of Ophthalmology Aims and scope Submit manuscript

Abstract

Purpose

Omidenepag isopropyl (OMDI) is the prodrug of omidenepag, a selective, non-prostaglandin, prostanoid EP2 receptor agonist, which has been shown to lower intraocular pressure (IOP) in patients with glaucoma and ocular hypertension (OHT). This study evaluated the efficacy and safety of OMDI ophthalmic solution 0.002% in patients with primary open-angle glaucoma or OHT who were non-/low responders to latanoprost.

Study design

Open-label, multicenter, Phase 3 study (NCT02822742).

Methods

Following 1–4-week washout, patients were treated with latanoprost ophthalmic solution 0.005% during an 8-week run-in period. Patients with ≤15% IOP reduction at the end of the run-in (indicating non-/low response) received OMDI 0.002% (one drop once daily for 4 weeks). The primary endpoint was the change from baseline in mean diurnal IOP at Week 4.

Results

In total, 26 patients were treated with OMDI; two withdrew owing to lack of efficacy. The mean diurnal IOP at baseline (end of latanoprost run-in) was 23.1 mmHg (7.6% IOP reduction from end of washout) indicating non-/low response to latanoprost. After 4 weeks of OMDI treatment, mean diurnal IOP was significantly reduced from baseline (−2.99 mmHg; P < 0.0001). No serious adverse events were reported. Adverse events occurred in five patients (19.2%); adverse drug reactions (anterior chamber cell, conjunctival hyperemia, and erythema of eyelid) occurred in two patients (7.7%) and were mild in severity.

Conclusions

In this study, OMDI 0.002% demonstrated a clinically significant reduction in IOP and was well tolerated in patients with primary open-angle glaucoma and OHT who were non-/low responders to latanoprost.

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Acknowledgements

Medical writing was provided by Sandra Callagy, PhD, and Jennifer Mitchell, PhD, both of Helios Medical Communications, Cheshire, UK, which was funded by Santen. The study was sponsored by Santen.

Author information

Authors and Affiliations

  1. Ophthalmology, University of Tokyo, Tokyo, Japan

    Makoto Aihara

  2. Santen Oy, Vantaa, Finland

    Auli Ropo

  3. Santen Inc., Emeryville, CA, USA

    Fenghe Lu, Noriko Odani-Kawabata & Naveed Shams

  4. Santen Pharmaceutical Co., Ltd, Osaka, Japan

    Hisashi Kawata, Akihiro Iwata, Noriko Odani-Kawabata & Naveed Shams

Authors
  1. Makoto Aihara
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  2. Auli Ropo
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  3. Fenghe Lu
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  4. Hisashi Kawata
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  5. Akihiro Iwata
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  6. Noriko Odani-Kawabata
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Corresponding author

Correspondence to Auli Ropo.

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Conflicts of interest

M. Aihara, Grant, Research support, Financial support, Consultant fee, Lecture fee (Alcon), Financial support, Lecture fee (Johnson & Johnson), Financial support, Consultant fee, Lecture fee (Crewt Medical Systems, Glaukos, Kowa, Otsuka), Consultant fee, Lecture fee (HOYA, IRIDEX), Financial support, Lecture fee (Nitten, Novartis, Ono), Grant, Research support, Financial support, Consultant fee, Lecture fee, Travel fee (Pfizer), Financial support, Consultant fee, Lecture fee, Travel fee (Santen, Senju), Grant, Research support, Financial support, Lecture fee (Sato), Financial support, Lecture fee (TOMEY), Financial support, Consultant fee (Wakamoto), Consultant fee, Lecture fee (InnFocus), Lecture fee (NIDEK, Ivantis, Canon, ZEISS), Consultant fee (Astellas); A. Ropo, Employee (Santen); F. Lu, Employee (Santen); H. Kawata, Employee (Santen); A. Iwata, Employee (Santen); N. O. Kawabata, Employee (Santen); N. Shams, Employee (Santen).

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Corresponding Author: Auli Ropo

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Aihara, M., Ropo, A., Lu, F. et al. Intraocular pressure-lowering effect of omidenepag isopropyl in latanoprost non-/low-responder patients with primary open-angle glaucoma or ocular hypertension: the FUJI study. Jpn J Ophthalmol 64, 398–406 (2020). https://doi.org/10.1007/s10384-020-00748-x

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  • DOI: https://doi.org/10.1007/s10384-020-00748-x

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