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

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

Cystoid macular edema associated with omidenepag isopropyl in a phakic eye with an implantable collamer lens: a case report. (PubMed, BMC Ophthalmol) - "We report a case of cystoid macular edema development after omidenepag isopropyl use in a patient with glaucoma who had undergone bilateral implantable collamer lens implantation. This case shows that the possibility of cystoid macular edema occurrence should be considered when omidenepag isopropyl is used, even in phakic eyes, after the insertion of implantable collamer lenses."

Journal • Glaucoma • Macular Edema • Ophthalmology • PTGER2

Effects of Brimonidine, Omidenepag Isopropyl, and Ripasudil Ophthalmic Solutions to Protect against HO-Induced Oxidative Stress in Human Trabecular Meshwork Cells. (PubMed, Curr Eye Res) - "In vitro, HO treatment of HTM cells induced characteristic changes of OAG, such as fibrosis changes and the upregulation of stress markers. These glaucomatous changes were attenuated by additional treatments with brimonidine, omidenepag isopropyl, and ripasudil ophthalmic solutions."

Journal • Fibrosis • Glaucoma • Immunology • Ophthalmology • COL1A1 • FN1 • HSPA5 • MMP2 • XBP1

Recently Approved Drugs for Lowering and Controlling Intraocular Pressure to Reduce Vision Loss in Ocular Hypertensive and Glaucoma Patients. (PubMed, Pharmaceuticals (Basel)) - "A unique nitric oxide-donating conjugate of latanoprost, an FP-receptor prostaglandin (PG; latanoprostene bunod), new rho kinase inhibitors (ripasudil; netarsudil), a novel non-PG EP2-receptor-selective agonist (omidenepag isopropyl), and a form of FP-receptor PG in a slow-release intracameral implant (Durysta) represent the additions to the pharmaceutical toolchest to mitigate the ravages of OHT. Despite these advances, early diagnosis of OHT and glaucoma still lags behind and would benefit from further concerted effort and attention."

Journal • Review • Cardiovascular • Glaucoma • Ocular Inflammation • Ophthalmology • Optic Neuritis • Pain

Identifying new drugs and targets to treat rapidly elevated intraocular pressure for angle closure and secondary glaucomas to curb visual impairment. (PubMed, Exp Eye Res) - "However, translation of the novel animal-based findings to the human conditions remains to be demonstrated but represent viable targets, especially EP-receptor agonists (e.g. omidenepag isopropyl; AL-6598; butaprost), mixed activity serotonin/dopamine receptor agonists (e.g. cabergoline), rho kinase inhibitors (e.g. AMA0076, Y39983), CACNA2D1-gene product inhibitors (e.g. pregabalin), melatonin receptor agonists, and certain K-channel openers (e.g. nicorandil, pinacidil). Other drug candidates and targets were also identified and will be discussed."

Journal • Review • Cardiovascular • Glaucoma • Infectious Disease • Ocular Inflammation • Ophthalmology

FP and EP2 prostanoid receptor agonist drugs and aqueous humor outflow devices for treating ocular hypertension and glaucoma. (PubMed, Exp Eye Res) - "FPAs, such as latanoprost, travoprost, bimatoprost, and tafluprost, powerfully lower and control intraocular pressure (IOP), and became first-line therapeutics to treat this leading cause of blindness in the late 1990s to early 2000s. More recently, a latanoprost-nitric oxide (NO) donor conjugate, latanoprostene bunod, and a novel FP/EP3 receptor dual agonist, sepetaprost (ONO-9054 or DE-126), have also demonstrated robust IOP-reducing activity. Moreover, a selective non-PG prostanoid EP2 receptor agonist, omidenepag isopropyl (OMDI), was discovered, characterized, and has been approved in the United States, Japan and several other Asian countries for treating OHT/glaucoma...This has successfully been achieved by the recent approval and introduction of miniature devices into the anterior chamber by minimally invasive glaucoma surgeries. This review covers the three major aspects mentioned above to highlight the etiology of OHT/glaucoma, and the pharmacotherapeutics and..."

Journal • Review • Cardiovascular • Glaucoma • Ophthalmology • PTGER2

Influence of 0.002% Omidenepag Isopropyl on Intraocular Pressure and the Cornea in Normal Tension Glaucoma. (PubMed, J Glaucoma) - "OMDI eye drops elicited significant and stable IOP reductions after 6 months in NTG patients with low IOP. However, transient myopic and corneal endothelial cell changes, development of corneal thickening, and corneal erosion should be considered when using OMDI."

Journal • Corneal Abrasion • Glaucoma • Ophthalmology

Downregulation of COL12A1 and COL13A1 by a selective EP2 receptor agonist, omidenepag, in human trabecular meshwork cells. (PubMed, PLoS One) - "Omidenepag isopropyl (OMDI) is an intraocular pressure (IOP)-lowering drug used to treat glaucoma...Reduction in the extracellular matrix contributes to the decrease in outflow resistance, suggesting that the downregulation of the two related genes may be one of the factors influencing the IOP-lowering effect of OMDI. Our findings provide insights for the use of OMDI in clinical practice."

Journal • Glaucoma • Ophthalmology • COL18A1 • COL1A1 • COL1A2

Omidenepag Isopropyl. (PubMed, Am J Health Syst Pharm) - No abstract available

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