TIMOPTIC IN OCUDOSE (timolol maleate)
TIMOPTIC IN OCUDOSE is indicated for the treatment of Ocular Hypertension; Open-Angle Glaucoma.
Details
- Status
- Prescription
- First Approved
- 1986-11-05
- Routes
- OPHTHALMIC
- Dosage Forms
- SOLUTION/DROPS
TIMOPTIC IN OCUDOSE Approval History
What TIMOPTIC IN OCUDOSE Treats
2 indicationsTIMOPTIC IN OCUDOSE is approved for 2 conditions since its original approval in 1986. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Ocular Hypertension
- Open-Angle Glaucoma
TIMOPTIC IN OCUDOSE 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 TIMOPTIC IN OCUDOSE's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications TIMOPTIC IN OCUDOSE treats. First-in-class if their pivotal trials read out positive.
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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| NCT01607671 | NAION-001 | Ph 1 | withdrawn | Treatment Study for Ischemic Optic Neuropathy With Opthalmic Timolol Maleate 0.5% |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 IN OCUDOSE FDA Label Details
Indications & Usage
FDA Label (PDF)TIMOPTIC IN OCUDOSE 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.