BETOPTIC S (betaxolol hydrochloride)
BETOPTIC S helps patients with chronic open-angle glaucoma or ocular hypertension by lowering high pressure inside the eye. This medication is used to manage elevated intraocular pressure, which is a significant risk factor for optic nerve damage and vision loss. By controlling these pressure levels, the drug helps protect the patient's visual field from further damage.
How BETOPTIC S Works
This medication works by inhibiting beta-1-adrenergic receptors to decrease the production of aqueous fluid within the eye. Reducing the amount of fluid produced leads to a lower level of intraocular pressure. While it targets the eye, it is designed to have minimal effects on a patient's heart or lung function.
Details
- Status
- Prescription
- First Approved
- 1989-12-29
- Routes
- OPHTHALMIC
- Dosage Forms
- SUSPENSION/DROPS
BETOPTIC S Approval History
What BETOPTIC S Treats
2 indicationsBETOPTIC S is approved for 2 conditions since its original approval in 1989. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Chronic Open-Angle Glaucoma
- Ocular Hypertension
BETOPTIC S 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 BETOPTIC S's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications BETOPTIC S treats. First-in-class if their pivotal trials read out positive.
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3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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.
BETOPTIC S FDA Label Details
Indications & Usage
FDA Label (PDF)BETOPTIC S is indicated for the treatment of Chronic Open-Angle Glaucoma; Ocular Hypertension.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.