Overview
Latanoprost is a prodrug analog of prostaglandin F2 alpha that is used to treat elevated intraocular pressure (IOP). It was initially approved by the FDA in 1998. Latanoprost is the first topical prostaglandin F2 alpha analog used for glaucoma treatment. It has been found to be well-tolerated and its use does not normally result in systemic adverse effects like other drugs used to treat elevated intraocular pressure, such as Timolol. Another benefit latanoprost is that it can be administered once a day.
Indication
Latanoprost is indicated for the reduction of elevated intraocular pressure in patients who have been diagnosed with open-angle glaucoma or ocular hypertension. It is available as monotherapy or in a combination product with netarsudil or timolol. In Canada, latanoprost is also indicated to treat elevated intraocular pressure due to angle-closure glaucoma that has been treated with peripheral iridotomy or laser iridoplasty.
Associated Conditions
- Increased Intra Ocular Pressure (IOP)
- Ocular Hypertension
- Open Angle Glaucoma (OAG)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/05/09 | Phase 2 | Recruiting | |||
2025/05/06 | Phase 2 | Not yet recruiting | VSPharmTech Co.,Ltd. | ||
2025/03/19 | Phase 4 | Recruiting | Prairie Eye Center | ||
2025/02/11 | N/A | Recruiting | Colorado Ophthalmology Associates PC | ||
2024/12/12 | Early Phase 1 | Completed | |||
2024/10/31 | Phase 3 | Recruiting | |||
2024/10/07 | Phase 1 | Completed | |||
2024/06/04 | Phase 2 | Not yet recruiting | |||
2024/05/09 | Phase 4 | Terminated | |||
2024/02/02 | Phase 1 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Somerset Therapeutics, LLC | 70069-421 | OPHTHALMIC | 50 ug in 1 mL | 3/9/2023 | |
| FDC Limited | 55545-1010 | OPHTHALMIC | 50 ug in 1 mL | 11/29/2019 | |
| NuCare Pharmaceuticals,Inc. | 68071-4650 | OPHTHALMIC | 50 ug in 1 mL | 2/17/2021 | |
| Aurobindo Pharma Limited | 65862-872 | OPHTHALMIC | 50 ug in 1 mL | 4/11/2023 | |
| ImprimisRx NJ | 70261-515 | OPHTHALMIC | 0.05 mg in 1 mL | 5/8/2018 | |
| NuCare Pharmaceuticals,Inc. | 68071-2376 | OPHTHALMIC | 50 ug in 1 mL | 3/26/2021 | |
| Alcon Laboratories, Inc. | 70727-529 | OPHTHALMIC, TOPICAL | 0.05 mg in 1 mL | 6/2/2020 | |
| PFIZER LABORATORIES DIV PFIZER INC | 0013-8303 | OPHTHALMIC | 50 ug in 1 mL | 12/27/2022 | |
| NuCare Pharmaceuticals,Inc. | 68071-4893 | OPHTHALMIC | 50 ug in 1 mL | 1/29/2021 | |
| Thea Pharma Inc. | 82584-003 | OPHTHALMIC | 50 ug in 1 mL | 10/26/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 11/15/2023 | ||
Authorised | 1/7/2021 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| XALATAN EYE DROPS 0.005% | SIN09549P | SOLUTION | 50 mcg/ml | 11/21/1997 | |
| XALACOM EYE DROPS | SIN11922P | SOLUTION | 50mcg/ml | 5/11/2002 | |
| LATOCHEK STERILE EYE DROPS 0.005% | SIN14956P | SOLUTION, STERILE | 0.05mg/ml | 2/19/2016 | |
| LATANDROPS EYE DROPS SOLUTION 50mcg/ml | SIN14590P | SOLUTION | 0.050 mg | 8/15/2014 | |
| LANOTAN OPHTHALMIC SOLUTION 0.005% w/w | SIN14399P | SOLUTION | 0.005% w/w | 8/27/2013 | |
| ARISTO-LATA Latanoprost Eye Drops 0.005% w/v | SIN17024P | SOLUTION | 0.005%w/v | 6/11/2024 | |
| LATACHIMO COMBINATION OPHTHALMIC SOLUTION “NITTO” | SIN15974P | SOLUTION, STERILE | 0.05 mg/ml | 7/16/2020 | |
| PROSDROP EYE DROPS SOLUTION 0.05 MG/ML | SIN15135P | SOLUTION | 0.050 mg/ ml | 12/12/2016 | |
| LATACOM EYE DROPS | SIN16927P | SOLUTION, STERILE | 0.05mg/mL | 1/12/2024 | |
| LATANO SANTEN OPHTHALMIC SOLUTION, 0.005%w/v | SIN16849P | SOLUTION, STERILE | 0.005%w/v | 8/31/2023 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Latanoprost Eye Drops | 国药准字H20249433 | 化学药品 | 眼用制剂 | 11/22/2024 | |
| Latanoprost Eye Drops | 国药准字H20044234 | 化学药品 | 滴眼剂 | 5/16/2020 | |
| Latanoprost Eye Drops | 国药准字HJ20181171 | 化学药品 | 眼用制剂 | 12/28/2022 | |
| Latanoprost Eye Drops | 国药准字H20153305 | 化学药品 | 眼用制剂(滴眼剂) | 12/11/2020 | |
| Latanoprost Eye Drops | 国药准字HJ20230111 | 化学药品 | 眼用制剂 | 8/28/2024 | |
| Latanoprost Eye Drops | 国药准字H20093866 | 化学药品 | 滴眼剂 | 12/15/2023 | |
| Latanoprost Eye Drops | 国药准字HJ20171094 | 化学药品 | 眼用制剂 | 2/22/2022 | |
| Latanoprost Eye Drops | 国药准字H20063035 | 化学药品 | 眼用制剂 | 11/9/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| TYGLACOM EYE DROPS SOLUTION 50MCG/ML+5MG/ML | N/A | N/A | N/A | 10/14/2015 | |
| LATAMED EYE DROPS | N/A | N/A | N/A | 11/18/2024 | |
| MONOPOST EYE DROPS 50MCG/ML | N/A | N/A | N/A | 11/23/2018 |
TGA Drug Approvals
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