J Korean Ophthalmol Soc.  2023 Oct;64(10):939-944. 10.3341/jkos.2023.64.10.939.

Retrospective Analysis of the Efficacy and Safety of Omidenepag Isopropyl 0.002% Ophthalmic Solution in Korean Patients

• Lee H
• Lee SY
• Bae HW
• Kim CY
• Choi W

• KMID: 2546815
• DOI: http://doi.org/10.3341/jkos.2023.64.10.939

Abstract

Purpose
This study aimed to analyze the clinical efficacy and safety of omidenepag isopropyl (OMDI) 0.002% in Korean patients.
Methods
A retrospective study was conducted involving 306 patients diagnosed with glaucoma or ocular hypertension, who were administered OMDI 0.002% from May 2021 to June 2022. The primary outcomes were the change in intraocular pressure (IOP) at months 1, 3, and 6 compared to the baseline IOP, and the reactions to the OMDI drug.
Results
Out of 235 patients who met the study inclusion criteria, the mean IOP was 16.5 ± 3.4 mmHg at baseline, 14.5 ± 3.0 mmHg at month 1, 14.3 ± 2.7 mmHg at month 3, and 14.7 ± 3.1 mmHg at month 6. The mean IOP reduction at month 6 was -1.6 ± 2.8 mmHg (p < 0.001). On analyzing the IOP by types of glaucoma, the mean IOP change at the 6-month point showed statistically significant results in all types, including normal tension glaucoma, primary open-angle glaucoma, and ocular hypertension (p < 0.05). The frequency of side effects in all patients was 29.8%, with the most commonly reported adverse drug reaction being hyperemia in 18.7% of the total patients. There was one case (0.4%) of uveitis after OMDI administration, but no other systemic adverse drug reactions were reported.
Conclusions
Omidenepag isopropyl demonstrated a statistically significant IOP-lowering effect in Korean patients with various types of glaucoma. This suggests that OMDI could potentially serve as a first-line treatment for glaucoma.

Keyword

Adverse drug reaction, Glaucoma, IOP-lowering effect, Omidenepag isopropyl, Prostanoid EP2 receptor agonist