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)
Research Report
A Comprehensive Monograph on Latanoprost: Pharmacology, Clinical Efficacy, and Therapeutic Landscape
Executive Summary
Latanoprost, a prostaglandin F2α analog, represents a cornerstone in the modern therapeutic management of glaucoma and ocular hypertension. Its introduction in 1996 revolutionized treatment paradigms due to its potent intraocular pressure (IOP)-lowering efficacy, convenient once-daily dosing regimen, and a favorable systemic safety profile that set it apart from previous standards of care. As an isopropyl ester prodrug, Latanoprost is designed for optimal corneal penetration, where it is hydrolyzed into its active acid form to exert its therapeutic effect. It acts locally by selectively targeting the prostanoid FP receptor, which initiates a cascade of cellular changes that increase aqueous humor outflow primarily through the uveoscleral pathway, an alternative drainage route to the conventional trabecular meshwork.
While highly effective, the clinical profile of Latanoprost is characterized by a well-defined and predictable set of ocular side effects. The most notable of these are conjunctival hyperemia (ocular redness), gradual and permanent changes in iris pigmentation, and reversible changes to eyelashes, including increased length, thickness, and darkness. The therapeutic landscape of Latanoprost has evolved significantly from its initial launch as a single blockbuster brand (Xalatan®). It has matured into a competitive market featuring multiple generic versions, value-added formulations designed to improve tolerability, and strategic fixed-dose combinations aimed at enhancing efficacy. This evolution reflects a growing clinical focus on mitigating long-term ocular surface toxicity, leading to the development of benzalkonium chloride (BAK)-free (Xelpros®) and entirely preservative-free (Iyuzeh™) formulations. Furthermore, fixed-dose combinations with agents like timolol and the novel Rho kinase inhibitor netarsudil (Rocklatan®)
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 | Active, not 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 |
---|---|---|---|---|---|
No NMPA approvals found for this drug. |
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
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
LATANOPROST / TIMOLOL | 02553848 | Solution - Ophthalmic | 50 MCG / ML | N/A | |
M-LATANOPROST-TIMOLOL | mantra pharma inc | 02514516 | Solution - Ophthalmic | 50 MCG / ML | 11/10/2021 |
LATANOPROST OPHTHALMIC SOLUTION | hikma canada limited | 02489570 | Solution - Ophthalmic | 50 MCG / ML | 6/26/2020 |
MINT-LATANOPROST/TIMOLOL | mint pharmaceuticals inc | 02444666 | Solution - Ophthalmic | 50 MCG / ML | N/A |
SANDOZ LATANOPROST/TIMOLOL | 02394685 | Solution - Ophthalmic | 50 MCG / ML | 3/4/2013 | |
SANDOZ LATANOPROST | 02367335 | Solution - Ophthalmic | 50 MCG / ML | 12/6/2011 | |
RIVA-LATANOPROST/TIMOLOL | laboratoire riva inc. | 02459205 | Solution - Ophthalmic | 50 MCG / ML | 1/3/2017 |
MYLAN-LATANOPROST/TIMOLOL | Mylan Pharmaceuticals ULC | 02422492 | Solution - Ophthalmic | 50 MCG / ML | N/A |
RIVA-LATANOPROST | laboratoire riva inc. | 02341085 | Solution - Ophthalmic | 50 MCG / ML | 5/11/2015 |
TEVA-LATANOPROST/TIMOLOL | teva canada limited | 02393921 | Solution - Ophthalmic | 50 MCG / ML | N/A |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
XALACOM 50 microgramos/ml + 5 mg/ml COLIRIO EN SOLUCION | 64187 | COLIRIO EN SOLUCIÓN | Medicamento Sujeto A Prescripción Médica | Commercialized | |
LATANOPROST/TIMOLOL RAFARM 50 MICROGRAMOS/ML+ 5 MG/ML COLIRIO EN SOLUCION | 78435 | COLIRIO EN SOLUCIÓN | Medicamento Sujeto A Prescripción Médica | Not Commercialized | |
ARUCOM 50 MICROGRAMOS/ML+ 5 MG/ML COLIRIO EN SOLUCION | Dr. Gerhard Mann Chem.-Pharm. Fabrik Gmbh | 76208 | COLIRIO EN SOLUCIÓN | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
LATANOPROST QUALIGEN 50 MICROGRAMOS/ML COLIRIO EN SOLUCION | Neuraxpharm Spain S.L. | 74843 | COLIRIO EN SOLUCIÓN | Medicamento Sujeto A Prescripción Médica | Commercialized |
LATANOPROST MEDICAL MIX 50 microgramos/ml COLIRIO EN SOLUCION | Farmamix Vision S.L. | 73520 | COLIRIO EN SOLUCIÓN | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
ROCLANDA 50 MICROGRAMOS/ML + 200 MICROGRAMOS/ML COLIRIO EN SOLUCION | 1201502001 | COLIRIO EN SOLUCIÓN | Diagnóstico Hospitalario | Commercialized | |
XALATAN 50 MICROGRAMOS/ML COLIRIO EN SOLUCION | BE183967 | COLIRIO EN SOLUCIÓN | Medicamento Sujeto A Prescripción Médica | Not Commercialized | |
LATANOPROST/TIMOLOL FARMALIDER 50 MICROGRAMOS/ML + 5MG/ML COLIRIO EN SOLUCION | Farmalider S.A. | 76571 | COLIRIO EN SOLUCIÓN | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
LATANOPROST VIATRIS 50 MICROGRAMOS/ML COLIRIO EN SOLUCION | 71102 | COLIRIO EN SOLUCIÓN | Medicamento Sujeto A Prescripción Médica | Commercialized | |
MONOPROST 50 MICROGRAMOS/ML COLIRIO EN SOLUCION EN ENVASE UNIDOSIS | 6400313C | COLIRIO EN SOLUCIÓN EN ENVASE UNIDOSIS | Medicamento Sujeto A Prescripción Médica | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
---|---|---|---|---|---|
No UK EMC drug information found for this drug. |
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