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

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:

• omidenepag isopropyl
• prostanoid EP2 agonist
• 24-hour IOP control

Data Sharing Statement

The datasets analyzed during this study are available from the corresponding author on reasonable request.

Acknowledgments

The author thanks to Mr. Kazunori Santo who provided in the technical assistance. This study was sponsored by Santen Pharmaceutical Co., Ltd.

Disclosure

The authors have made the following disclosure: NS, YN, AT, SS and KT received non-financial research support from Santen Pharmaceutical Co., Ltd. during the conduct of study; NO, NI, DS, and KH were employees of Santen Pharmaceutical Co., Ltd.; KN had a consulting relationship with Santen Pharmaceutical Co., Ltd and reports personal fees from Shinanozaka Clinic. The authors report no other conflicts of interest in this work.