TRAVOPROST
Travoprost ophthalmic solution (ionic buffered solution) 0.004% is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open angle glaucoma or ocular hypertension.
Details
- Status
- Discontinued
- First Approved
- 2013-03-01
- Routes
- OPHTHALMIC
- Dosage Forms
- SOLUTION/DROPS, SOLUTION
TRAVOPROST Approval History
What TRAVOPROST Treats
9 FDA approvalsOriginally approved for its first indication in 2013 . Covers 9 distinct patient populations.
- Other (9)
Other
(9 approvals)- • Approved indication (Mar 2013)
- • Approved indication (Jul 2015)Letter
- • Approved indication (Jul 2017)
- • Approved indication (Dec 2019)
- • Approved indication (Mar 2021)
- • Approved indication (May 2024)
- • Approved indication (Jul 2024)
- • Approved indication (Sep 2024)
- • Approved indication (Dec 2025) New
Clinical Trial Registry
8 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02390284 STOP-RGCD results posted | 20140587 R01EY014957 | Ph 3 | terminated | Stop Retinal Ganglion Cell Dysfunction Study |
| NCT04615403 results posted | IDOS-106-EXCH | Ph 2 | completed | Study of Exchange of Travoprost Intraocular Implant |
| NCT01444040 | GCF-027 | Ph 4 | completed | Subjects With Open-angle Glaucoma, Pseudoexfoliative Glaucoma, or Ocular Hypertension Naïve to Medical and Surgical Therapy, Treated With Two Trabecular Micro-bypass Stents (iStent Inject) or Travoprost |
| NCT02914509 results posted | OTX-16-002 | Ph 3 | completed | Phase 3 Study Evaluating Safety and Efficacy of OTX-TP in Subjects With OAG or OHT |
| NCT01443988 | GCF-022 | Ph 4 | completed | Subjects With Open-angle Glaucoma, Pseudoexfoliative Glaucoma, or Ocular Hypertension Naïve to Medical and Surgical Therapy, Treated With Two Trabecular Micro-bypass Stents (iStent)or Travoprost |
| NCT01315574 BAK results posted | 11-007H | Ph 4 | terminated | Effects of Anti-Glaucoma Medications on the Ocular Surface |
| NCT02105311 | EC57-020-02-1 | Ph 4 | completed | Effect of Selective Laser Trabeculoplasty Versus Travoprost on Circardian Intraocular Pressure |
| NCT00705757 results posted | Pfizer GA6111AX | Ph 4 | completed | The Effects of Xalatan, Travatan and Lumigan on Skin Pigmentation Near the Eye |
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.
TRAVOPROST FDA Label Details
Indications & Usage
Travoprost ophthalmic solution (ionic buffered solution) 0.004% is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open angle glaucoma or ocular hypertension. Travoprost ophthalmic solution (ionic buffered solution) 0.004% is a prostaglandin analog indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.