AZOPT (brinzolamide)
Azopt helps patients with elevated pressure inside the eye, a condition that can lead to optic nerve damage and permanent vision loss. It is used for individuals diagnosed with open-angle glaucoma or ocular hypertension to manage these risks. By lowering this internal pressure, the medication helps protect the eye's long-term health and visual field.
How AZOPT Works
This medication works by blocking an enzyme called carbonic anhydrase II within the eye's ciliary processes. Inhibiting this enzyme slows the formation of bicarbonate ions, which reduces the transport of sodium and fluids. This process decreases the production of aqueous humor, resulting in a reduction of internal eye pressure.
Development Insights
Details
- Status
- Prescription
- First Approved
- 1998-04-01
- Routes
- OPHTHALMIC
- Dosage Forms
- SUSPENSION/DROPS
AZOPT Approval History
What AZOPT Treats
2 indicationsAZOPT is approved for 2 conditions since its original approval in 1998. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Ocular Hypertension
- Open-Angle Glaucoma
AZOPT 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.
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 AZOPT's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications AZOPT treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to AZOPT
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 |
|---|---|---|---|---|
| NCT02390284 STOP-RGCD results posted | 20140587 R01EY014957 | Ph 3 | terminated | Stop Retinal Ganglion Cell Dysfunction Study |
| NCT00767494 | C-07-63 | Ph 3 | terminated | Travoprost/Brinzolamide Fixed Combination Versus Travatan and Versus AZOPT |
| NCT00761995 | MA-CT-08-003 | Ph 4 | completed | Safety and Efficacy of Brinzolamide Dosed TID With Dorzolamide Dosed TID in Reducing Intraocular Pressure in Patients With Open Angle Glaucoma or Ocular Hypertension |
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.
AZOPT FDA Label Details
Indications & Usage
FDA Label (PDF)AZOPT is indicated for the treatment of Ocular Hypertension; Open-Angle Glaucoma.
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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