LATANOPROSTENE BUNOD
Latanoprostene bunod is an eye drop that helps patients with open-angle glaucoma or ocular hypertension by lowering the pressure within the eye. It is used to manage these conditions because elevated intraocular pressure is a significant risk factor for the progression of glaucoma. By reducing this pressure, the medication helps protect against the loss of a patient's visual field.
How LATANOPROSTENE BUNOD Works
This medication works by increasing the drainage of aqueous humor through two different channels in the eye. It promotes fluid outflow through both the trabecular meshwork and the uveoscleral routes, which results in a reduction of intraocular pressure.
Details
- Status
- Prescription
- First Approved
- 2025-04-29
- Routes
- OPHTHALMIC
- Dosage Forms
- SOLUTION/DROPS
LATANOPROSTENE BUNOD Approval History
What LATANOPROSTENE BUNOD Treats
2 indicationsLATANOPROSTENE BUNOD is approved for 2 conditions since its original approval in 2025. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Open-Angle Glaucoma
- Ocular Hypertension
LATANOPROSTENE BUNOD Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in LATANOPROSTENE BUNOD's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications LATANOPROSTENE BUNOD treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to LATANOPROSTENE BUNOD
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
3 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04140279 | 899 | Ph 4 | withdrawn | A Study to Evaluate the Effect of Latanoprostene Bunod Ophthalmic Solution 0.024% on Episcleral Venous Pressure and Outflow Facility in Participants With Ocular Hypertension |
| NCT01895972 JUPITER results posted | 811 | Ph 3 | completed | Long-Term Safety of Latanoprostene Bunod Ophthalmic Solution 0.024% in Japanese Subjects With OAG or OHT |
| NCT01895985 KRONUS | 849 | Ph 1 | completed | Efficacy of Latanoprostene Bunod in Lowering Intraocular Pressure in Japanese Healthy Male Volunteers |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
LATANOPROSTENE BUNOD FDA Label Details
Indications & Usage
LATANOPROSTENE BUNOD is indicated for the treatment of Open-Angle Glaucoma; Ocular Hypertension.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.