Observational studyAdvances in therapy2022
Interim Results of Post-Marketing Observational Study of Omidenepag Isopropyl for Glaucoma and Ocular Hypertension in Japan.
Observational study in Advances in therapy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
8 citing papers in PubMed, 16 citations in OpenAlex.
- Effectiveness and Safety of Omidenepag Isopropyl 0.002% Ophthalmic Solution in Treatment-Naive Patients With Primary Open Angle Glaucoma: A Prospective Multicenter Phase IV Study.Journal of glaucoma · 2025Trial
- Effects of Topical Omidenepag Isopropyl on Intraocular Pressure and Pupil Diameter in Normal Dogs.Veterinary ophthalmology · 2026Article
- Benefit of omidenepag isopropyl ophthalmic solution in treatment persistence in Japanese patients with glaucoma.Scientific reports · 2025Observational
- Five-Year Outcomes of Omidenepag Isopropyl Monotherapy for Untreated Primary Open-Angle Glaucoma.Cureus · 2025Article
- Objective hyperemia and intraocular pressure changes following omidenepag isopropyl application.PloS one · 2025Observational
- Three-year efficacy and safety of omidenepag isopropyl in patients with normal tension glaucoma.Japanese journal of ophthalmology · 2024Article
- Cystoid macular edema associated with omidenepag isopropyl in a phakic eye with an implantable collamer lens: a case report.BMC ophthalmology · 2023Article
- Recently Approved Drugs for Lowering and Controlling Intraocular Pressure to Reduce Vision Loss in Ocular Hypertensive and Glaucoma Patients.Pharmaceuticals (Basel, Switzerland) · 2023Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionThis post-marketing observational interim analysis evaluated the 12-month effectiveness and safety of omidenepag isopropyl (OMDI) ophthalmic solution in daily clinical settings.
methodsThis 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).
resultsA 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%.
conclusionThis 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.
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