BRIMONIDINE TARTRATE AND TIMOLOL MALEATE (brimonidine tartrate)
This ophthalmic solution helps patients with glaucoma or ocular hypertension by lowering high pressure inside the eye. It is used when a patient's intraocular pressure is not adequately controlled and they require additional or alternative therapy. By reducing this pressure, the medication helps manage a major risk factor for optic nerve damage and loss of vision.
How BRIMONIDINE TARTRATE AND TIMOLOL MALEATE Works
The medication works by combining two different active ingredients that target the production and drainage of fluid in the eye. Brimonidine acts as an alpha-2 agonist to both decrease fluid production and increase its outflow, while timolol acts as a beta-blocker to further lower eye pressure. Together, these actions provide a rapid onset of effect to reduce the risk of glaucomatous field loss.
Details
- Status
- Prescription
- First Approved
- 2022-04-04
- Routes
- OPHTHALMIC
- Dosage Forms
- SOLUTION/DROPS
Companies
BRIMONIDINE TARTRATE AND TIMOLOL MALEATE Approval History
What BRIMONIDINE TARTRATE AND TIMOLOL MALEATE Treats
2 indicationsBRIMONIDINE TARTRATE AND TIMOLOL MALEATE is approved for 2 conditions since its original approval in 2022. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Glaucoma
- Ocular Hypertension
BRIMONIDINE TARTRATE AND TIMOLOL MALEATE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
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 BRIMONIDINE TARTRATE AND TIMOLOL MALEATE's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications BRIMONIDINE TARTRATE AND TIMOLOL MALEATE treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to BRIMONIDINE TARTRATE AND TIMOLOL MALEATE
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.
BRIMONIDINE TARTRATE AND TIMOLOL MALEATE FDA Label Details
Indications & Usage
BRIMONIDINE TARTRATE AND TIMOLOL MALEATE is indicated for the treatment of Glaucoma; Ocular Hypertension.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.