Interim Results of Post-Marketing Observational Study of Omidenepag Isopropyl for Glaucoma and Ocular Hypertension in Japan.

INTRODUCTION: This post-marketing observational interim analysis evaluated the 12-month effectiveness and safety of omidenepag isopropyl (OMDI) ophthalmic solution in daily clinical settings. METHODS: This was a multicenter, large-scale, non-interventional, prospective, observational study conducted in Japan. The target enrollment was 3900 patients, and the overall observation period was 12 months. Patients with glaucoma and ocular hypertension (OH) with no previous history of OMDI use were enrolled. The key endpoints were change in intraocular pressure (IOP) from baseline and the incidence of adverse reactions (ADRs). RESULTS: A total of 1862 patients were evaluated in this 12-month interim analysis. Most patients were diagnosed with normal-tension glaucoma (NTG, 62.0%). The treatment patterns with OMDI were naïve monotherapy (48.4%), switching monotherapy (18.4%), and concomitant therapy (31.1%). The overall incidence of ADRs was 24.3%, which was similar between the monotherapy and concomitant therapy groups. Common ADRs were conjunctival hyperemia, refractive disorder, and myopia. Macular edema was observed in four patients. No ADRs categorized as prostaglandin-associated periorbitopathy were observed. There was a significant reduction in mean IOP at 12 months, with a change of - 1.9 ± 2.9 mmHg from baseline (reduction - 10.4 ± 16.5%). The mean IOP change from baseline was - 2.7 ± 2.6 mmHg in the naïve monotherapy group, - 1.1 ± 2.6 mmHg in the switching monotherapy group, and - 1.6 ± 3.1 mmHg in the concomitant therapy group (all P < 0.05). The mean IOP decreased by - 2.5 ± 3.2 mmHg, - 1.5 ± 2.4 mmHg, and - 2.3 ± 4.5 mmHg in the primary open-angle glaucoma (POAG), NTG, and OH groups, respectively. The treatment persistence with OMDI was 82.4%. CONCLUSION: This study demonstrated the safety and efficacy of OMDI for glaucoma and OH as monotherapy and concomitant therapy in daily clinical settings. In this interim analysis, OMDI showed a favorable benefit-risk profile, and can be first-line therapy for glaucoma.