TIMOPTIC-XE (timolol maleate)
TIMOPTIC-XE is a gel-forming eye solution used to lower high pressure inside the eye. It helps patients with open-angle glaucoma or ocular hypertension manage their condition. By reducing intraocular pressure, the medication helps prevent the optic nerve damage and vision loss often associated with these eye disorders.
How TIMOPTIC-XE Works
This medication works by blocking both beta 1 and beta 2 adrenergic receptors. Its primary effect is to reduce the formation of aqueous fluid within the eye, which lowers internal pressure. It may also provide a slight increase in the eye's ability to drain fluid.
Development Insights
Details
- Status
- Prescription
- First Approved
- 1993-11-04
- Routes
- OPHTHALMIC
- Dosage Forms
- SOLUTION, GEL FORMING/DROPS
TIMOPTIC-XE Approval History
What TIMOPTIC-XE Treats
2 indicationsTIMOPTIC-XE is approved for 2 conditions since its original approval in 1993. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Ocular Hypertension
- Open-Angle Glaucoma
TIMOPTIC-XE 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 TIMOPTIC-XE's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications TIMOPTIC-XE 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.
Clinical Trial Registry
5 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04830397 | QC-201 | Ph 2 | completed | Study to Evaluate QLS-101 Compared to Timolol Maleate Eye Drops in Subjects With High Eye Pressure (Glaucoma or Ocular Hypertension). |
| NCT03323164 results posted | 17-636E | Ph 4 | completed | Peripapillary Blood Flow After Use of Anti-glaucoma Medications: An OCT Angiography Study |
| NCT01707381 Constellation results posted | 803 | Ph 2 | completed | BOL-303259-X With Timolol 0.5% in Subjects With Open-Angle Glaucoma or Ocular Hypertension |
| NCT01607671 | NAION-001 | Ph 1 | withdrawn | Treatment Study for Ischemic Optic Neuropathy With Opthalmic Timolol Maleate 0.5% |
| NCT00879099 | 73654 Eudra CT 2008-007324-26 | Ph 1 | completed | Interaction Study of Timolol Eye Drops and Paroxetine Capsules |
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.
TIMOPTIC-XE FDA Label Details
Indications & Usage
FDA Label (PDF)TIMOPTIC-XE 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