Trial reportJapanese journal of ophthalmology2020
Intraocular pressure-lowering effect of omidenepag isopropyl in latanoprost non-/low-responder patients with primary open-angle glaucoma or ocular hypertension: the FUJI study.
Trial report in Japanese journal of ophthalmology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02822742 (A Phase III, Open-label, Single-arm, Multi-center Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution in Subjects With Primary Open-angle Glaucoma or Ocular Hypertension Who Are Non-/Low-responders to Latanoprost Ophthalmic Solution), which is not on this map. Cited by 27 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.
A Phase III, Open-label, Single-arm, Multi-center Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution in Subjects With Primary Open-angle Glaucoma or Ocular Hypertension Who Are Non-/Low-responders to Latanoprost Ophthalmic Solution: FUJI Study
Who cites it
27 citing papers in PubMed, 55 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
- Omidenepag Isopropyl 0.002% versus Latanoprost 0.005% in Open-Angle Glaucoma/Ocular Hypertension: The Randomized Phase III PEONY Trial.Clinical ophthalmology (Auckland, N.Z.) · 2024Trial
- Twelve-month efficacy and safety of omidenepag isopropyl, a selective EP2 agonist, in open-angle glaucoma and ocular hypertension: the RENGE study.Japanese journal of ophthalmology · 2021Trial
- Diffuse bilateral macular edema associated with omidenepag isopropyl in phakic eyes after laser iridotomy: a case report.Japanese journal of ophthalmology · 2026Article
- Effects of Omidenepag Isopropyl Versus Latanoprost Eye Drops on Intraocular Pressure, Pupil Diameter, and Anterior Chamber Parameters in Normal Feline Eyes: A Pilot Study.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
- Relationship Between Intraocular Pressure-Lowering Effects and Alterations in Anterior Segment Scleral Birefringence Following Micropulse Cyclophotocoagulation.Clinical ophthalmology (Auckland, N.Z.) · 2025Article
- Ocular Tissue Distribution of Omidenepag Isopropyl in Rabbits and Cynomolgus Monkeys.Translational vision science & technology · 2024Article
- Three-year efficacy and safety of omidenepag isopropyl in patients with normal tension glaucoma.Japanese journal of ophthalmology · 2024Article
- Currently available prostanoids for the treatment of glaucoma and ocular hypertension: A review.Current opinion in pharmacology · 2024Review
- Recently Approved Drugs for Lowering and Controlling Intraocular Pressure to Reduce Vision Loss in Ocular Hypertensive and Glaucoma Patients.Pharmaceuticals (Basel, Switzerland) · 2023Review
- The Japan Glaucoma Society guidelines for glaucoma 5th edition.Japanese journal of ophthalmology · 2023Article
- Downregulation of COL12A1 and COL13A1 by a selective EP2 receptor agonist, omidenepag, in human trabecular meshwork cells.PloS one · 2023Article
- FDA-Approved Small Molecules in 2022: Clinical Uses and Their Synthesis.Pharmaceutics · 2022Review
- Fibrotic Response of Human Trabecular Meshwork Cells to Transforming Growth Factor-Beta 3 and Autotaxin in Aqueous Humor.Biomolecules · 2022Article
- Potential Mechanisms of Intraocular Pressure Reduction by Micropulse Transscleral Cyclophotocoagulation in Rabbit Eyes.Investigative ophthalmology & visual science · 2022Article
- Efficacy and Safety of Omidenepag Isopropyl 0.002% Ophthalmic Solution: A Retrospective Analysis of Real-World Data in Japan.Advances in therapy · 2022Article
- Interim Results of Post-Marketing Observational Study of Omidenepag Isopropyl for Glaucoma and Ocular Hypertension in Japan.Advances in therapy · 2022Observational
- The Roles Played by FP/EP3 Receptors During Pressure-lowering in Mouse Eyes Mediated by a Dual FP/EP3 Receptor Agonist.Investigative ophthalmology & visual science · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 4 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeOmidenepag isopropyl (OMDI) is the prodrug of omidenepag, a selective, non-prostaglandin, prostanoid EP2 receptor agonist, which has been shown to lower intraocular pressure (IOP) in patients with glaucoma and ocular hypertension (OHT). This study evaluated the efficacy and safety of OMDI ophthalmic solution 0.002% in patients with primary open-angle glaucoma or OHT who were non-/low responders to latanoprost. STUDY
designOpen-label, multicenter, Phase 3 study (NCT02822742).
methodsFollowing 1-4-week washout, patients were treated with latanoprost ophthalmic solution 0.005% during an 8-week run-in period. Patients with ≤15% IOP reduction at the end of the run-in (indicating non-/low response) received OMDI 0.002% (one drop once daily for 4 weeks). The primary endpoint was the change from baseline in mean diurnal IOP at Week 4.
resultsIn total, 26 patients were treated with OMDI; two withdrew owing to lack of efficacy. The mean diurnal IOP at baseline (end of latanoprost run-in) was 23.1 mmHg (7.6% IOP reduction from end of washout) indicating non-/low response to latanoprost. After 4 weeks of OMDI treatment, mean diurnal IOP was significantly reduced from baseline (-2.99 mmHg; P < 0.0001). No serious adverse events were reported. Adverse events occurred in five patients (19.2%); adverse drug reactions (anterior chamber cell, conjunctival hyperemia, and erythema of eyelid) occurred in two patients (7.7%) and were mild in severity.
conclusionsIn this study, OMDI 0.002% demonstrated a clinically significant reduction in IOP and was well tolerated in patients with primary open-angle glaucoma and OHT who were non-/low responders to latanoprost.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.