Omlonti (omidenepag isopropyl) / Santen, Ube Corp - LARVOL DELTA

Effects of Omidenepag Isopropyl Versus Latanoprost Eye Drops on Intraocular Pressure, Pupil Diameter, and Anterior Chamber Parameters in Normal Feline Eyes: A Pilot Study. (PubMed, Vet Ophthalmol) - "OMDI effectively reduced IOP in cats for at least 4 h without reducing PD. An increase in the CCA and mid-CCW, observed exclusively with OMDI, suggests that the hypotensive effect may be mediated by the conventional outflow pathway. Additionally, an increase in CMT in both the OMDI- and latanoprost-treated eyes may indicate an effect on the uveoscleral outflow pathway."

Journal • Glaucoma • Ophthalmology

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. (PubMed, J Glaucoma) - "Omidenepag isopropyl 0.002% ophthalmic solution is suitable for first-line use at first diagnosis of POAG, including in patients with NTG."

Journal • P4 data • Glaucoma • Macular Edema • Ocular Inflammation • Ophthalmology • Uveitis

Omidenepag Isopropyl-Associated Cystoid Macular Edema After Trabeculectomy. (PubMed, JAMA Ophthalmol) - No abstract available

Journal • Macular Edema • Ophthalmology

Prostaglandin EP2 Receptor and Cystoid Macular Edema in Phakic Posttrabeculectomy Eyes. (PubMed, JAMA Ophthalmol) - "Omidenepag isopropyl (OMDI), a prostaglandin EP2 receptor agonist, effectively reduces intraocular pressure but has a known risk of cystoid macular edema (CME), particularly in pseudophakic and aphakic eyes...Cystoid macular edema can develop after initiating OMDI in patients with phakic eyes with a history of trabeculectomy prior to initiating OMDI. Further studies would be needed to understand the magnitude of this association and risk factors for this finding."

Journal • Glaucoma • Macular Edema • Ophthalmology

Safety and Efficacy of Omidenepag Isopropyl for Elevated Intraocular Pressure: A Systematic Review and Meta-Analysis. (PubMed, Am J Ophthalmol) - "OMDI 0.002% offers an alternative to FPs for IOP management especially when FPs may not be effective or suitable. While its efficacy is comparable, clinicians must consider the increased risk of AEs with OMDI. Short follow-up periods constrained the assessment of long-term efficacy and rare AEs; however, the absence of eyelash-related changes and prostaglandin associated periorbitopathy offers a cosmetic advantage over FPs. Further research could identify patient subgroups who may benefit from OMDI treatment."

Journal • Retrospective data • Review • Glaucoma • Ophthalmology

The Clinical Efficacy of a Topical Selective EP2 Receptor Agonist Against Feline Glaucoma That Is Not Responsive to Conventional Anti-Glaucoma Eyedrops. (PubMed, Vet Ophthalmol) - "OMDI could be an additional therapeutic option for feline glaucoma that is unresponsive to conventional therapies. Administration of OMDI following the early diagnosis of glaucoma is recommended to maximize therapeutic efficacy."

Journal • Cardiovascular • Cataract • Glaucoma • Hypertension • Ocular Inflammation • Ophthalmology • Uveitis

Objective hyperemia and intraocular pressure changes following omidenepag isopropyl application. (PubMed, PLoS One) - "One eye in the new administration group that developed macular edema during the observation period resolved spontaneously upon discontinuing omidenepag isopropyl. Both hyperemia and IOP reduction with omidenepag isopropyl ophthalmic solution were comparable to those achieved with F-prostanoid receptor agonists."

Journal • Observational data • Glaucoma • Macular Edema • Ophthalmology

Effectiveness and Safety of Omidenepag Isopropyl 0.002% Ophthalmic Solution in Treatment-Naïve Patients with Primary Open-Angle Glaucoma: A Prospective Multicenter Phase IV Study. (PubMed, J Glaucoma) - "Omidenepag isopropyl 0.002% ophthalmic solution is suitable for first-line use at first diagnosis of POAG, including in patients with NTG."

Journal • P4 data • Glaucoma • Macular Edema • Ocular Inflammation • Ophthalmology • Uveitis

Onconetix Signs Letter of Intent for Potential Business Combination with Ocuvex Therapeutics, Inc. (GlobeNewswire) - "Onconetix, Inc...and Ocuvex Therapeutics, Inc...today announced that they have signed a Non-Binding Letter of Intent contemplating a potential business combination transaction with Ocuvex...Onconetix and Ocuvex will continue negotiations to enter into a definitive agreement. Upon closing of the proposed transaction, Onconetix will acquire all the issued and outstanding equity interests of Ocuvex in exchange for newly issued shares of common stock of Onconetix. Immediately following the closing of the proposed transaction, the pre-closing Ocuvex equity holders will own approximately 90% of the equity interests in Onconetix."

M&A • Glaucoma

Bioequivalence of Preservative-Free and Preserved Omidenepag Isopropyl 0.002% Ophthalmic Solutions in Patients With Primary Open Angle Glaucoma or Ocular Hypertension: Phase 3 DAISY Study. (PubMed, J Glaucoma) - "Preservative-free DE-117B and BAK-containing OMDI were bioequivalent in lowering IOP after 4 weeks' treatment in Japanese patients with POAG or OHT. DE-117B was well tolerated with a similar safety profile to OMDI."

Clinical • Journal • P3 data • Cardiovascular • Glaucoma • Ophthalmology

Pathogenic role of Thy-1 in prostaglandin-associated periorbitopathy (ARVO 2025) - "3T3-L1 cells were treated with dimethyl sulfoxide (control), 1 μM bimatoprost (BIMA), or 1 μM omidenepag isopropyl (OMDI, negative control) for 48 hours. Our study found that bimatoprost increases Thy-1 expression, driving orbital cells toward a myofibroblast fate that causes tissue tightening. These results suggest a pathological role for Thy-1 in severe PAP and provide insights for potential therapeutic strategies."

Ophthalmology • ACTA2 • THY1

Ocular Tissue Distribution of Omidenepag Isopropyl in Rabbits and Cynomolgus Monkeys. (PubMed, Transl Vis Sci Technol) - "Neither OMD nor OMDI interacted with the target receptors or enzymes of other antiglaucoma agents, suggesting that OMD interacts highly selectively with EP2 receptors. OMDI is a specific antiglaucoma agent that interacts selectively with ocular EP2 receptors."

Journal • Preclinical • Glaucoma • Ophthalmology

Omidenepag Isopropyl 0.002% versus Latanoprost 0.005% in Open-Angle Glaucoma/Ocular Hypertension: The Randomized Phase III PEONY Trial. (PubMed, Clin Ophthalmol) - P3 | "Most AEs were mild, with no serious ocular AEs. OMDI safely and effectively reduces IOP in Asian subjects with OAG/OHT, with mean diurnal IOP at Month 3 and per-timepoint IOP reductions non-inferior to those of latanoprost."

Clinical • Journal • P3 data • Cardiovascular • Glaucoma • Ophthalmology

Activation of the PGE2-EP2 pathway as a potential drug target for treating eosinophilic rhinosinusitis. (PubMed, Front Immunol) - "Current treatments of eosinophilic chronic rhinosinusitis (ECRS) involve corticosteroids with various adverse effects and costly therapies such as dupilumab, highlighting the need for improved treatments...ECRS is often associated with aspirin-induced asthma, suggesting that dysregulation of lipid mediators in the nasal mucosa may underlie ECRS pathology...These results suggest that the present model using Ptges-deficient mice is more relevant to human ECRS than are previously reported models and that eosinophilic inflammation in the nasal mucosa can be efficiently blocked by activation of the PGE2-EP2 pathway. Furthermore, our findings suggest that drug repositioning of omidenepag isopropyl may be useful for treatment of patients with ECRS."

Journal • Asthma • Glaucoma • Immunology • Inflammation • Ophthalmology • Otorhinolaryngology • Pulmonary Disease • Respiratory Diseases • Sinusitis

Three-year outcome of omidenepag isopropyl in primary open angle glaucoma and preperimetric glaucoma (ARVO 2024) - "OMDI reduced IOP for 3 years in patients with open angle glaucoma when used as the initial treatment. Also OMDI showed insignificant IOP lowering effects when switched to from prostagrandin F2α, it was just maintained. These data suggest OMDI can be used as an effective first-line medication for patients with glaucoma."

Cataract • Glaucoma • Ophthalmology

Three-year efficacy and safety of omidenepag isopropyl in patients with normal tension glaucoma. (PubMed, Jpn J Ophthalmol) - "After the administration of omidenepag isopropyl, IOP in patients with NTG decreased within 3 years, visual fields were maintained, and safety was satisfactory. Thus, omidenepag isopropyl can be used as the first-line treatment for patients with NTG."

Journal • Glaucoma • Ophthalmology

Omidenepag Isopropyl Versus Timolol in Patients With Glaucoma or Ocular Hypertension: Two Randomized Phase 3 Trials (SPECTRUM 4 and 3). (PubMed, Am J Ophthalmol) - "SPECTRUM 4 and 3 demonstrated consistent 3-month IOP-lowering efficacy and safety of OMDI vs timolol in patients with glaucoma or OHT. The 12-month data from SPECTRUM 3 suggest OMDI may have long-term benefits in patients with glaucoma or OHT."

Journal • P3 data • Cardiovascular • Glaucoma • Macular Edema • Ophthalmology • Pediatrics

Human experience and efficacy of omidenepag isopropyl (Eybelis®; Omlonti®): Discovery to approval of the novel non-prostaglandin EP2-receptor-selective agonist ocular hypotensive drug. (PubMed, Curr Opin Pharmacol) - "In an additional month-long clinical study, 0.002% OMDI induced IOP-lowering equivalent to that of latanoprost (0.005%), a prostanoid FP-receptor agonist, thus OMDI was noninferior to latanoprost. However, OMDI caused transient conjunctival hyperemia. These characteristics of OMDI render it a suitable new medication for treating OHT and various types of glaucoma, especially where elevated IOP is implicated."

Journal • Review • Cardiovascular • Glaucoma • Ophthalmology • COL12A1

Currently available prostanoids for the treatment of glaucoma and ocular hypertension: A review. (PubMed, Curr Opin Pharmacol) - "Emergent PGAs, such as latanoprostene bunod, fixed-dose netarsudil combined with latanoprost, and omidenepag Isopropyl, offer enhanced or non-inferior IOP reduction. The bimatoprost implant introduces a novel administration method with effective IOP reduction. These developments underscore ongoing progress in PGA-focused ophthalmological research. This article offers a comprehensive review of available prostanoid analogs and explores new developments."

Journal • Review • Cardiovascular • Glaucoma • Ophthalmology

New Drugs: Faricimab-svoa (Vabysmo) for Macular Degeneration and Diabetic Macular Edema and Omidenepag Isopropyl (Omlonti) for Glaucoma and Ocular Hypertension. (PubMed, Sr Care Pharm) - "Two drugs are covered in this quarterly column. Faricimab-svoa (Vabysmo) for Macular Degeneration and Diabetic Macular Edema and Omidenepag Isopropyl (Omlonti) for Glaucoma and Ocular Hypertension."

Journal • Age-related Macular Degeneration • Cardiovascular • Diabetic Macular Edema • Glaucoma • Macular Degeneration • Ophthalmology • Retinal Disorders

Omidenepag Isopropyl in Latanoprost Low/Non-Responders with Primary Open-Angle Glaucoma or Ocular Hypertension: A Phase 3, Non-Randomized, Two-Phase, Open-Label Study. (PubMed, J Glaucoma) - P3 | "These data demonstrate OMDI efficacy and safety in latanoprost low/non-responders with POAG or OHT, suggesting OMDI is a treatment option in the patient population in this study."

Clinical • Journal • P3 data • Cardiovascular • Glaucoma • Ophthalmology

DE-117 Spectrum 5 Study (clinicaltrials.gov) - P3 | N=107 | Completed | Sponsor: Santen Inc. | Unknown status ➔ Completed

Trial completion • Cardiovascular • Glaucoma • Ophthalmology

A Phase III Study Assessing the Efficacy and Safety of DE-117 Ophthalmic Solution Compared With Timolol Maleate Ophthalmic Solution 0.5% in Subjects With Glaucoma or Ocular Hypertension - Spectrum 3 Study (clinicaltrials.gov) - P3 | N=426 | Completed | Sponsor: Santen Inc. | Unknown status ➔ Completed

Trial completion • Cardiovascular • Glaucoma • Ophthalmology

Clinical Efficacy of Omidenepag Isopropyl for Primary Open-Angle Glaucoma, Normal Tension Glaucoma, or Ocular Hypertension: A Meta-Analysis. (PubMed, J Ocul Pharmacol Ther) - "The country of origin of the recruited studies and OMDI dosage frequencies were also found to have no effect on overall IOP changes after OMDI treatment. The current meta-analysis indicates OMDI to be a clinically effective treatment for glaucoma patients in terms of lowering IOP levels."

Journal • Retrospective data • Cardiovascular • Glaucoma • Ophthalmology

A Phase III Study Assessing the Efficacy and Safety of DE-117 Ophthalmic Solution Compared With Timolol Maleate Ophthalmic Solution 0.5% in Subjects With Glaucoma or Ocular Hypertension - Spectrum 4 Study (clinicaltrials.gov) - P3 | N=417 | Completed | Sponsor: Santen Inc. | Unknown status ➔ Completed

Trial completion • Cardiovascular • Glaucoma • Ophthalmology