SIMBRINZA (brimonidine tartrate)
Simbrinza is a fixed-combination ophthalmic suspension consisting of a carbonic anhydrase inhibitor (brinzolamide) and an alpha-2 adrenergic receptor agonist (brimonidine tartrate). It is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. By effectively managing IOP, Simbrinza helps mitigate the risk of progressive optic nerve damage and glaucomatous visual field loss.
How SIMBRINZA Works
Simbrinza reduces intraocular pressure through two distinct mechanisms of action. Brinzolamide inhibits the enzyme carbonic anhydrase (specifically isoenzyme II) in the ciliary processes, which slows the formation of bicarbonate ions and subsequently reduces sodium and fluid transport, thereby decreasing aqueous humor secretion. Brimonidine tartrate functions as a dual-action agent that reduces aqueous humor production and increases uveoscleral outflow. Together, these components decrease the net volume of aqueous humor, leading to a significant reduction in IOP.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2013-04-19
- Patent Cliff
- 2030
- Routes
- OPHTHALMIC
- Dosage Forms
- SUSPENSION/DROPS
SIMBRINZA Approval History
What SIMBRINZA Treats
2 indicationsSIMBRINZA is approved for 2 conditions since its original approval in 2013. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Glaucoma
- Ocular Hypertension
SIMBRINZA 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 SIMBRINZA's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications SIMBRINZA treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to SIMBRINZA
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
12 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05270863 results posted | VT-002 | Ph 3 | completed | Safety and Efficacy Study BRIMOCHOL™ PF and Carbachol PF in Subjects With Emmetropic Phakic or Pseudophakic Presbyopia |
| NCT03785340 results posted | OCU-310-301 | Ph 3 | completed | Study of Brimonidine Tartrate Nanoemulsion Eye Drop Solution in the Treatment of Dry Eye Disease (DED) |
| NCT03591874 oGVHD results posted | OCU-300-301 | Ph 3 | terminated | Study of Brimonidine Tartrate Nanoemulsion Eye Drops in Patients With Ocular Graft-vs-Host Disease |
| NCT03760185 results posted | 18-1713 | Ph 2 | completed | Pupil Dilation for Treatment of IFIS |
| NCT03323164 results posted | 17-636E | Ph 4 | completed | Peripapillary Blood Flow After Use of Anti-glaucoma Medications: An OCT Angiography Study |
| NCT01959230 results posted | 861 | Ph 3 | completed | Efficacy and Safety of Brimonidine Tartrate Ophthalmic Solution in Adult and Geriatric Participants With Ocular Redness |
| NCT01959243 results posted | 862 | Ph 3 | completed | Safety of Brimonidine Tartrate Ophthalmic Solution in a Population of Pediatric, Adult, and Geriatric Participants |
| NCT03966560 | KAEK-2014/04-74 | Ph 4 | completed | Choroidal Thickness and Its Correlations With Ocular Parameters in Primary Open-angle Glaucoma |
| NCT03173365 BRIMOCAN | BRIMOCAN | Ph 2 | terminated | The Effect of Topical Brimonidine Tartrate on Hand-foot Syndrome (HFS) in Cancer Patients |
| NCT02039765 | 863/13-100-0007 | Ph 1 | completed | Pharmacokinetics and Safety of Topical Administration of Brimonidine Tartrate Ophthalmic Solution 0.025%. |
| NCT02856919 BR14004 | BR.14.004 | Ph 4 | completed | A Multicenter, Open-label Clinical Trial to Evaluate the Efficacy and Safety of Once Daily Mirvaso® Gel in Patients With Chronic Persistent Vascular Facial Erythema. |
| NCT02568111 BRITE | NLD-PEG-14-10784 2015-002159-89 | Ph 4 | withdrawn | Brimonidine Tartrate for the Treatment of Injection Related Erythema |
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.
SIMBRINZA FDA Label Details
Indications & Usage
FDA Label (PDF)SIMBRINZA is indicated for the treatment of Glaucoma; Ocular Hypertension.
Pro Intelligence Preview
Deep insights for SIMBRINZA
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2030
- • 2 active patents
Trial Analysis
- • 12 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