BETOPTIC (betaxolol hydrochloride)
Betoptic S is an ophthalmic suspension indicated for the reduction of elevated intraocular pressure (IOP) in patients with chronic open-angle glaucoma or ocular hypertension. Lowering internal eye pressure is a critical therapeutic goal, as elevated IOP is a primary risk factor for optic nerve damage and permanent visual field loss.
How BETOPTIC Works
Betaxolol is a cardioselective (beta-1-adrenergic) receptor inhibitor that lowers both elevated and normal intraocular pressure. It achieves this by reducing the production of aqueous humor within the eye. Because of its cardioselective nature, ophthalmic betaxolol has minimal effect on pulmonary and cardiovascular parameters compared to non-selective beta-adrenergic antagonists.
Details
- Status
- Prescription
- First Approved
- 1985-08-30
- Routes
- OPHTHALMIC
- Dosage Forms
- SOLUTION/DROPS
BETOPTIC Approval History
What BETOPTIC Treats
2 indicationsBETOPTIC is approved for 2 conditions since its original approval in 1985. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Glaucoma
- Ocular Hypertension
BETOPTIC 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 BETOPTIC's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications BETOPTIC treats. First-in-class if their pivotal trials read out positive.
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Active Pipeline
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Key Completed Trials
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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.
BETOPTIC FDA Label Details
Indications & Usage
FDA Label (PDF)BETOPTIC 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.