TIMOPTIC (timolol maleate)
Timoptic is an ophthalmic solution used for patients with high pressure inside the eye, specifically those with open-angle glaucoma or ocular hypertension. It helps manage these conditions by lowering intraocular pressure, which is a significant risk factor for optic nerve damage and vision loss. A single dose can maintain this pressure-lowering effect for up to 24 hours.
How TIMOPTIC Works
This medication works by blocking both beta 1 and beta 2 adrenergic receptors. While the exact process is not fully established, evidence suggests it lowers eye pressure primarily by reducing the formation of aqueous fluid within the eye.
Details
- Status
- Prescription
- First Approved
- 1978-08-17
- Routes
- OPHTHALMIC
- Dosage Forms
- SOLUTION/DROPS
TIMOPTIC Approval History
What TIMOPTIC Treats
2 indicationsTIMOPTIC is approved for 2 conditions since its original approval in 1978. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Ocular Hypertension
- Open-Angle Glaucoma
TIMOPTIC 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's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications TIMOPTIC treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to TIMOPTIC
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 FDA Label Details
Indications & Usage
FDA Label (PDF)TIMOPTIC 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.