Efficacy and Safety of Omidenepag Isopropyl 0.002% Ophthalmic Solution: A Retrospective Analysis of Real-World Data in Japan

• Published in: Advances in therapy 2022-05, Vol.39 (5), p.2085-2095
• Main Authors: Miki, Atsuya, Miyamoto, Etsuyo, Ishida, Naruhiro, Shii, Daisuke, Hori, Kiyotaka
• Format: Article
• Language: English
• Subjects: Antihypertensive Agents - adverse effects; Cardiology; Drug-Related Side Effects and Adverse Reactions; Endocrinology; Glaucoma - drug therapy; Glaucoma, Open-Angle - drug therapy; Glycine - analogs & derivatives; Humans; Internal Medicine; Intraocular Pressure; Japan; Medicine; Medicine & Public Health; Ocular Hypertension - chemically induced; Ocular Hypertension - drug therapy; Oncology; Ophthalmic Solutions - adverse effects; Original Research; Pharmacology/Toxicology; Pyrazoles; Pyridines; Retrospective Studies; Rheumatology; Treatment Outcome
• ISSN: 0741-238X; 1865-8652
• DOI: 10.1007/s12325-022-02069-6

Introduction This study aimed to clarify the efficacy and safety of omidenepag isopropyl (OMDI) in a retrospective, real-world, multicenter setting. Methods A retrospective medical chart review of patients with glaucoma and ocular hypertension receiving OMDI from November 2018 to November 2019 with at least 12 weeks of follow-up was conducted in 11 eye clinics in Japan. The participants were categorized into three therapy groups, designated the naïve monotherapy, switching monotherapy, and concomitant therapy groups. The main outcome measures were the change in intraocular pressure (IOP) at week 4 and week 12 after the initiation of OMDI treatment, and frequency of adverse drug reactions. Results Data were collected from 827 patients. The baseline IOP in the naïve group was 16.6 ± 4.2 mmHg. The mean IOP reduction at week 4 and week 12 was − 2.9 ± 3.2 mmHg ( P