To assess the long-term safety and efficacy of omidenepag isopropyl (OMDI) 0.002% (a first-in-class, selective, non-prostaglandin, prostanoid EP2 receptor agonist), alone or administered concomitantly with timolol 0.5%, in patients with open-angle glaucoma (OAG, including normal-tension and exfoliation glaucoma) or ocular hypertension (OHT).
Open-label, multicenter, Phase 3 study (NCT02822729).
Patients aged ≥ 20 years, with OAG or OHT, and a baseline diurnal intraocular pressure (IOP) ≥ 16– < 22 mmHg (Group 1) or ≥ 22– ≤ 34 mmHg (Groups 2 and 3) were enrolled. All patients (N = 125) received OMDI 0.002% once daily. Group 3 also received timolol 0.5% twice daily. IOP was measured at baseline and at Weeks 2, 4, 8, 12, 26, 40, and 52.
Significant reductions in mean diurnal IOP from baseline occurred at every visit (P < 0.0001). Mean ± SE diurnal IOP reduction at Week 52 was −3.7 ± 0.3 mmHg (Group 1), −5.6 ± 0.5 mmHg (Group 2), and −8.4 ± 0.6 mmHg (Group 3). Most adverse events (AEs) were mild, and no serious treatment-related AEs were reported. Conjunctival hyperemia (incidence: monotherapy [Groups 1 and 2], 18.8%; concomitant [Group 3], 45.0%) and macular edema (ME)/cystoid macular edema (CME) (incidence: monotherapy, 11.8%; concomitant, 15.0%) occurred most frequently. All treatment-related ME/CME cases occurred in pseudophakic eyes and responded to standard-of-care treatment and study drug discontinuation.
In this study, OMDI 0.002%, alone or administered concomitantly with timolol 0.5%, resulted in sustained IOP reduction over 52 weeks in patients with OAG or OHT. Concomitant treatment resulted in increased efficacy and increased incidence of conjunctival hyperemia.
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Medical writing was provided by Alex Yardley, BSc, and Jennifer Mitchell, PhD, both of Helios Medical Communications, Cheshire, UK, which was funded by Santen. This study was sponsored by Santen. The authors would like to thank Santen for their support in the development of this manuscript, in particular, Naveed K Shams, MD, PhD, for his input on the study design and for his review of the data presented.
Conflicts of interest
M. Aihara, Grant, Research support, honoraria/consultation fees, and has participated in a company-sponsored speaker’s bureau (Alcon), Grant, Research support, and has participated in a company-sponsored speaker’s bureau (AMO Japan), Research support (CREWT Medical Systems), Research support, Research support and honoraria/consultation fees (Glaukos), Honoraria/consultation fees (HOYA), Honoraria/consultation fees (IRIDEX), Grant, Research support and has participated in a company-sponsored speaker’s bureau (Kowa Pharmaceutical), Grant, Research support and has participated in a company-sponsored speaker’s bureau (Nippon Tenganyaku), Grant, Research support and has participated in a company-sponsored speaker’s bureau (Novartis), Research support and honoraria/consultation fees (Ono Pharmaceutical), Grant, Research support and has participated in a company-sponsored speaker’s bureau (Otsuka Pharmaceutical), Research support and has participated in a company-sponsored speaker’s bureau (Pfizer), Grant, Research support and honoraria/consultation fees, and has participated in a company-sponsored speaker’s bureau (Santen), Grant (Sato Pharmaceutical), Grant, Research support and honoraria/consultation fees, and has participated in a company-sponsored speaker’s bureau (SENJU Pharmaceutical), Grant, Research support and has participated in a company-sponsored speaker’s bureau (TOMEY), Grant, Research support and honoraria/consultation fees (Wakamoto Pharmaceutical); F. Lu, Employee (Santen); H. Kawata, Employee (Santen); A. Iwata, Employee (Santen); N. Odani-Kawabata, Employee (Santen).
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Corresponding Author: Fenghe Lu
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Aihara, M., Lu, F., Kawata, H. et al. Twelve-month efficacy and safety of omidenepag isopropyl, a selective EP2 agonist, in open-angle glaucoma and ocular hypertension: the RENGE study. Jpn J Ophthalmol (2021). https://doi.org/10.1007/s10384-021-00868-y
- EP2 receptor agonist
- Ocular hypertension
- Omidenepag isopropyl
- Phase 3