Twenty-Four-Hour Intraocular Pressure Control with Omidenepag Isopropyl 0.002% in Patients with Glaucoma and Ocular Hypertension

Naka Shiratori; Yusuke Nishio; Ayaka Takeda; Shio Sugimoto; Kenji Takazawa; Naomi Otsuka; Naruhiro Ishida; Daisuke Shii; Kiyotaka Hori; Kenji Nakamoto

doi:10.2147/OPTH.S333042

Twenty-Four-Hour Intraocular Pressure Control with Omidenepag Isopropyl 0.002% in Patients with Glaucoma and Ocular Hypertension

Clin Ophthalmol. 2021 Oct 4:15:3997-4003. doi: 10.2147/OPTH.S333042. eCollection 2021.

Authors

Naka Shiratori^{1

2}, Yusuke Nishio^{1

2}, Ayaka Takeda^{1

2}, Shio Sugimoto^{1

2}, Kenji Takazawa², Naomi Otsuka³, Naruhiro Ishida³, Daisuke Shii³, Kiyotaka Hori³, Kenji Nakamoto¹

Affiliations

¹ Department of Ophthalmology, Nippon Medical School, Tokyo, Japan.
² Shinanozaka Clinic, Tokyo, Japan.
³ Japan Medical Affairs Group, Santen Pharmaceutical Co. Ltd., Osaka, Japan.

Abstract

Purpose: To clarify the intraocular pressure (IOP)-lowering effect of a selective prostanoid EP2 receptor agonist, omidenepag isopropyl (OMDI) during a 24-hour period.

Patients and methods: Subjects aged ≥20 years and with diagnosed, untreated primary open-angle glaucoma or ocular hypertension were enrolled. IOP measurements were performed every 4 hours over a 24-hour period using a Goldmann applanation tonometer (GAT) and Icare PRO tonometer (PRO). The baseline 24-hour IOP was measured in untreated subjects. After the baseline measurements, participants were given OMDI 1 drop once daily at night for 4 weeks. At week 4, the IOP measurement was repeated under the same conditions. Diurnal (9 am, 1 pm, 5 pm) and nocturnal (9 pm, 1 am, 5 am) IOP measurements were compared between baseline and treatment with OMDI. Safety measures included adverse events, slit-lamp biomicroscopy, visual acuity, heart rate and blood pressure.

Results: Of 27 participants enrolled, 25 patients (20 males and 5 females, average age 52.2 ± 8.5 years) completed the study. In the sitting position, the baseline diurnal and nocturnal mean IOPs (GAT) were 19.1 ± 2.1 mmHg and 18.2 ± 2.6 mmHg, respectively, the diurnal and nocturnal mean IOP reduction from baseline were -2.8 ± 2.6 mmHg (p < 0.0001) and -3.3 ± 2.9 mmHg (p < 0.0001), respectively, mean 24-hour IOP (GAT) was significantly lower with the OMDI treatment (-3.1 ± 2.5 mmHg, p < 0.0001). In the supine position, the baseline nocturnal mean IOP (PRO) was 17.99 ± 2.22 mmHg, and the nocturnal mean IOP reduction from baseline was -1.78 ± 2.37 mmHg (p = 0.0009) after 4 weeks of the treatment. Nine adverse events were observed in 8 patients including mild conjunctival hyperemia (n = 8) and mild iritis (n=1). There were no significant effects on systemic safety.

Conclusion: Once daily OMDI treatment was able to produce stable 24-hour IOP reduction.

Keywords: 24-hour IOP control; omidenepag isopropyl; prostanoid EP2 agonist.