Overview
Travoprost ophthalmic solution is a topical medication used for controlling the progression of glaucoma or ocular hypertension, by reducing intraocular pressure . It is a synthetic prostaglandin F2alpha analog . Having been a well-received therapeutic agent with demonstrated efficacy and safety, travoprost is currently approved by the US FDA as a first-line treatment for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypotension . Furthermore, this approval also solidifies the medication as the first and only prostaglandin analog approved by the FDA for first-line treatment of glaucoma patients that does not contain the preservative benzalkonium chloride . Moreover, travoprost is also currently approved in the EU for the decrease of elevated intraocular pressure in paediatric patients aged 2 months to < 18 years with ocular hypertension or paediatric glaucoma .
Indication
Travoprost ophthalmic solution is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension . Travoprost is also currently indicated for the decrease of elevated intraocular pressure in paediatric patients aged 2 months to < 18 years with ocular hypertension or paediatric glaucoma .
Associated Conditions
- Increased Intra Ocular Pressure (IOP)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/09/03 | Phase 2 | Completed | |||
2023/12/01 | Phase 2 | Recruiting | |||
2023/10/04 | Phase 3 | Recruiting | |||
2021/04/30 | Not Applicable | Completed | |||
2020/11/04 | Phase 2 | Completed | |||
2020/07/08 | N/A | Completed | Kasr El Aini Hospital | ||
2019/05/29 | Phase 4 | Completed | Afyon Kocatepe University Hospital | ||
2019/05/28 | Phase 1 | Completed | |||
2017/05/12 | Phase 4 | Completed | |||
2016/09/26 | Phase 3 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Apotex Corp. | 60505-0593 | OPHTHALMIC | 0.04 mg in 1 mL | 12/5/2023 | |
| Novartis Pharmaceuticals Corporation | 0078-0946 | OPHTHALMIC | 0.04 mg in 1 mL | 7/12/2022 | |
| Bryant Ranch Prepack | 63629-8840 | OPHTHALMIC | 0.04 mg in 1 mL | 9/15/2021 | |
| Sandoz Inc | 0781-6185 | OPHTHALMIC | 0.04 mg in 1 mL | 9/29/2017 | |
| Mylan Pharmaceuticals Inc. | 0378-9651 | OPHTHALMIC | 0.04 mg in 1 mL | 1/14/2020 | |
| Bryant Ranch Prepack | 72162-2432 | OPHTHALMIC | 0.04 mg in 1 mL | 5/21/2025 | |
| Alembic Pharmaceuticals Inc. | 62332-510 | OPHTHALMIC | 0.04 mg in 1 mL | 12/20/2019 | |
| Golden State Medical Supply, Inc. | 51407-731 | OPHTHALMIC | 0.04 mg in 1 mL | 2/7/2024 | |
| Bryant Ranch Prepack | 63629-8839 | OPHTHALMIC | 0.04 mg in 1 mL | 9/15/2021 | |
| Glaukos Corporation | 25357-100 | INTRACAMERAL | 75 ug in 1 1 | 12/20/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 4/23/2006 | ||
Authorised | 11/27/2001 | ||
Authorised | 2/20/2014 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| TRAVOPROST PH&T EYE DROPS SOLUTION 40MCG/ML | SIN15305P | SOLUTION, STERILE | 0.040 mg/ml | 7/26/2017 | |
| TRAVATAN C EYE DROP SOLUTION 30MCG/ML | SIN15206P | SOLUTION, STERILE | 0.03 mg/ml | 4/10/2017 | |
| TRAVON EYE DROPS SOLUTION 0.004% | SIN15446P | SOLUTION, STERILE | 0.04mg/ ml | 3/9/2018 | |
| DuoTrav Eye Drops, Solution (5mg/40mcg) per mL | SIN13722P | SOLUTION, STERILE | 40 ug/ml | 11/3/2009 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Travoprost Eye Drops | 国药准字H20234330 | 化学药品 | 眼用制剂 | 10/18/2023 | |
| Travoprost Eye Drops | 国药准字H20173277 | 化学药品 | 眼用制剂 | 6/10/2022 | |
| Travoprost Eye Drops | 国药准字H20249647 | 化学药品 | 眼用制剂 | 12/1/2024 | |
| Travoprost Eye Drops | 国药准字H20233524 | 化学药品 | 眼用制剂 | 5/6/2023 | |
| Travoprost Eye Drops | 国药准字H20233127 | 化学药品 | 眼用制剂 | 2/7/2023 | |
| Travoprost Eye Drops | 国药准字H20234412 | 化学药品 | 滴眼剂 | 10/27/2023 | |
| Travoprost Eye Drops | 国药准字HJ20181024 | 化学药品 | 滴眼剂 | 6/9/2022 | |
| Travoprost Eye Drops | 国药准字H20203256 | 化学药品 | 眼用制剂 | 6/17/2020 | |
| Travoprost Eye Drops | 国药准字H20254288 | 化学药品 | 眼用制剂 | 5/27/2025 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| DUOTRAV EYE DROPS | N/A | N/A | N/A | 1/6/2007 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| DUOTRAV travoprost 0.004% and timolol 0.5% (as maleate) eye drop solution bottle | 177772 | Medicine | A | 3/15/2012 | |
| APO-TRAVOPROST/TIMOLOL 0.04/5 travoprost 40 micrograms/mL and timolol 5 mg/mL eye drops bottle | 304217 | Medicine | A | 6/12/2019 | |
| TRAVATAN 0.004% travoprost 40 microgram/mL eye drop solution bottle | 173354 | Medicine | A | 7/27/2011 |
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