VYZULTA (latanoprostene bunod)
Vyzulta is a prostaglandin analog that helps patients with open-angle glaucoma or ocular hypertension. It is used to lower intraocular pressure, which is a major risk factor for the progression of glaucoma. By reducing this pressure, the medication helps decrease the risk of visual field loss.
How VYZULTA Works
This medication works by increasing the drainage of aqueous humor through two different pathways in the eye: the trabecular meshwork and the uveoscleral routes. By improving the outflow of this fluid, the drug effectively lowers intraocular pressure.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2017-11-02
- Patent Cliff
- 2029
- Routes
- OPHTHALMIC
- Dosage Forms
- SOLUTION/DROPS
VYZULTA Approval History
What VYZULTA Treats
2 indicationsVYZULTA is approved for 2 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Open-Angle Glaucoma
- Ocular Hypertension
VYZULTA 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 VYZULTA's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications VYZULTA treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to VYZULTA
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| NCT04140279 | 899 | Ph 4 | withdrawn | A Study to Evaluate the Effect of Latanoprostene Bunod Ophthalmic Solution 0.024% on Episcleral Venous Pressure and Outflow Facility in Participants With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.
VYZULTA FDA Label Details
Indications & Usage
FDA Label (PDF)VYZULTA is indicated for the treatment of Open-Angle Glaucoma; Ocular Hypertension.
VYZULTA Patents & Exclusivity
Patents (1 active)
Pro Intelligence Preview
Deep insights for VYZULTA
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2029
- • 1 active patents
Trial Analysis
- • 3 total trials
- • Stage: Declining
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment