CLINICAL TRIALS PROFILE FOR LATANOPROST

505(b)(2) Clinical Trials for LATANOPROST

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Formulation	NCT03331770 ↗	Efficacy and Tolerability of an Innovative Formulation of BAK-free Latanoprost	Completed	Laboratorios Poen	Phase 4	2017-01-06	This study evaluates the efficacy and tolerability of a new formulation of latanoprost without Benzalkonium Chloride (BAK-free). Patients with open-angle glaucoma who were using BAK-containing latanoprost ophthalmic solution for ≥6 months, switched to BAK-free latanoprost ophthalmic emulsion.
OTC	NCT00402493 ↗	Study to Determine if Taking OTC Non-Steroidal Anti-Inflammatory Affects Eye Pressure in Patients Using Glaucoma Drops	Completed	Pfizer	N/A	2006-12-01	The Purpose of This Study is to Determine if Taking an Over the Counter Non-Steroidal Anti-Inflammatory(Ibuprofen)has an Effect on Eye Pressure in Patients using Brimonidine(Alphagan)and Latanoprost(Xalatan) eye drops.
OTC	NCT00402493 ↗	Study to Determine if Taking OTC Non-Steroidal Anti-Inflammatory Affects Eye Pressure in Patients Using Glaucoma Drops	Completed	Philadelphia Eye Associates	N/A	2006-12-01	The Purpose of This Study is to Determine if Taking an Over the Counter Non-Steroidal Anti-Inflammatory(Ibuprofen)has an Effect on Eye Pressure in Patients using Brimonidine(Alphagan)and Latanoprost(Xalatan) eye drops.

All Clinical Trials for LATANOPROST

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00140049 ↗	A 12week, Randomized, Evaluator-Masked, Parallel Group Comparing Evening Dosing Of Xalacom Vs Cosopt In Subj W/ Glaucoma	Completed	Pfizer	Phase 4	2005-07-01	To demonstrate the statistical non inferiority of the combination of latanoprost and timolol given in the evening time once a day vs the combination of dorzamalide and timolol twice a day based on intraocular pressure measurements at 8 AM, 12 noon & 4 PM during a 12 week treatment.
NCT00140049 ↗	A 12week, Randomized, Evaluator-Masked, Parallel Group Comparing Evening Dosing Of Xalacom Vs Cosopt In Subj W/ Glaucoma	Completed	Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	Phase 4	2005-07-01	To demonstrate the statistical non inferiority of the combination of latanoprost and timolol given in the evening time once a day vs the combination of dorzamalide and timolol twice a day based on intraocular pressure measurements at 8 AM, 12 noon & 4 PM during a 12 week treatment.
NCT00159653 ↗	A 12-Week, Randomized, Double-Masked, Parallel Group Comparison Of Evening Dosing With Xalacom In Subjects With Glaucoma	Completed	Pfizer	Phase 3	2005-07-01	To demonstrate statistical superiority of the combination of latanoprost and timolol to the individual therapy of latanoprost and timolol based on intraocular pressure measurements at 8 AM, 10 AM, 4 PM at weeks 2, 6 and 12.
NCT00143208 ↗	Evaluation Of Intraocular Pressure Lowering-Effect Of Xalacom In Patients With Poag Or Oh.	Completed	Pfizer	Phase 4	2003-05-01	This study is designed as an open label evaluation of the efficacy of latanoprost and timolol fixed combination (Xalacom) after 6 month of treatment. Eligible patients may be enrolled at the baseline visit. All current ocular hypotensive therapy must be discontinued at this time. On baseline day, patients eligible for the study will receive Xalacom which is to be instilled in the morning.
NCT00143208 ↗	Evaluation Of Intraocular Pressure Lowering-Effect Of Xalacom In Patients With Poag Or Oh.	Completed	Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	Phase 4	2003-05-01	This study is designed as an open label evaluation of the efficacy of latanoprost and timolol fixed combination (Xalacom) after 6 month of treatment. Eligible patients may be enrolled at the baseline visit. All current ocular hypotensive therapy must be discontinued at this time. On baseline day, patients eligible for the study will receive Xalacom which is to be instilled in the morning.
NCT00051142 ↗	A Safety and Efficacy Study of Travoprost 0.004% Compared to Latanoprost 0.005% in Patients With Open-Angle Glaucoma (OAG) or Ocular Hypertension (OHT)	Completed	Alcon Research	Phase 3	2001-02-01	The purpose of this study is to evaluate the safety and IOP-lowering efficacy of Travoprost (0.004%) compared to Latanoprost (0.005%) in patients with chronic open-angle glaucoma or ocular hypertension.
NCT00051181 ↗	A Safety and Efficacy Study of Travoprost 0.004% Compared to Latanoprost 0.005% in Patients With Chronic Angle-Closure Glaucoma	Completed	Alcon Research	Phase 3	2000-01-01	To demonstrate that the intraocular pressure(IOP)-lowering efficacy of Travoprost (0.004%) is equal or better than that of Latanoprost 0.005% in patients with chronic angle-closure glaucoma.

Clinical Trial Conditions for LATANOPROST

Condition Name

Condition Name for LATANOPROST
Intervention	Trials
Ocular Hypertension	102
Glaucoma	67
Open-Angle Glaucoma	24
Open Angle Glaucoma	16

Condition MeSH

Condition MeSH for LATANOPROST
Intervention	Trials
Glaucoma	155
Ocular Hypertension	127
Glaucoma, Open-Angle	104
Hypertension	98

Clinical Trial Locations for LATANOPROST

Trials by Country

+

−

Trials by Country for LATANOPROST
Location	Trials
United States	400
Italy	15
Canada	14
Greece	12
Japan	12

Trials by US State

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−

Trials by US State for LATANOPROST
Location	Trials
California	43
Texas	32
Georgia	26
New York	25
Florida	22

Clinical Trial Progress for LATANOPROST

Clinical Trial Phase

Clinical Trial Phase for LATANOPROST
Clinical Trial Phase	Trials
Phase 4	71
Phase 3	34
Phase 2/Phase 3	4

Clinical Trial Status

Clinical Trial Status for LATANOPROST
Clinical Trial Phase	Trials
Completed	131
Unknown status	21
Recruiting	17

Clinical Trial Sponsors for LATANOPROST

Sponsor Name

Sponsor Name for LATANOPROST
Sponsor	Trials
Pfizer	23
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	14
Alcon Research	13

Sponsor Type

Sponsor Type for LATANOPROST
Sponsor	Trials
Industry	147
Other	100
NIH	2

Latanoprost: Clinical Trials, Market Analysis, and Projections

Introduction to Latanoprost

Latanoprost is a small molecule drug and a prostaglandin analogue, primarily used to treat increased intraocular pressure (IOP) associated with conditions such as glaucoma and ocular hypertension. It works by increasing the outflow of aqueous humor, thereby reducing IOP and preventing optic nerve damage and vision loss[1][5].

Mechanism and Therapeutic Areas

Latanoprost acts as a prostanoid FP receptor agonist, which enhances the uveoscleral outflow of aqueous humor, thus reducing intraocular pressure. It is specifically indicated for the treatment of open-angle glaucoma and ocular hypertension[1].

Clinical Trials Update

Ongoing and Recent Trials

• NCX 470 vs. Latanoprost: Nicox SA has been conducting Phase 3 clinical trials comparing NCX 470, a novel NO-donating bimatoprost eye drop, with latanoprost. The Mont Blanc Phase 3 trial demonstrated that NCX 470 was non-inferior to latanoprost in reducing IOP and, in some time points, showed superior reductions. The Denali Phase 3 trial, currently ongoing in the U.S. and China, is expected to report topline results in the second half of 2025[4].

• Bioerodible Latanoprost Device: pSivida has announced a Phase I/II clinical study evaluating a bioerodible, sustained-release latanoprost device for the treatment of ocular hypertension and glaucoma. This study aims to assess the efficacy and safety of this new delivery system[3].

• Combination Therapies: Various studies have explored the efficacy of latanoprost in combination with other medications. For example, trials involving taprenepag and latanoprost are in Phase 2, evaluating the synergistic effects of these drugs in reducing IOP[1].

Market Analysis

Global Market Size and Growth

The global latanoprost market size was estimated to be USD 1.3 billion in 2023 and is projected to reach USD 1.6 billion by 2033, growing at a compound annual growth rate (CAGR) of 2.1% from 2024 to 2033[5].

Regional Market Breakdown

• North America: This region holds the largest share of the global latanoprost market, with a market size of USD 608.48 million in 2024. It is expected to grow at a CAGR of 0.7% from 2024 to 2031. The brand drug segment dominates this market, although generic alternatives are expected to enter as patents expire[2].

• Europe: The European market for latanoprost is significant, with a market size of USD 1521.2 million in 2024 and a projected CAGR of 1% from 2024 to 2031. The market is driven by an aging population and advanced healthcare infrastructure[2].

• Asia Pacific: This region holds around 23% of the global revenue, with a market size of USD 349.88 million in 2024. It is expected to grow at a CAGR of 4.5% from 2024 to 2031, driven by a large and diverse population and increasing prevalence of glaucoma and ocular hypertension[2].

• Latin America: The Latin American market accounts for more than 5% of the global revenue, with a market size of USD 76.06 million in 2024. It is expected to grow at a CAGR of 1.9% from 2024 to 2031, driven by demographic shifts and increasing awareness of eye health[2].

Market Drivers

Prevalence of Glaucoma and Ocular Hypertension

The rise in prevalence of glaucoma and ocular hypertension, particularly among the aging population, is a significant driver of the latanoprost market. These conditions are more common among elderly individuals, contributing to the increasing demand for latanoprost-based therapies[5].

Technological Advancements

Advancements in drug formulations and the development of combination therapies and sustained-release formulations are enhancing the effectiveness of latanoprost. These innovations ensure longer-lasting effects and better patient compliance, supporting market growth[5].

Early Diagnosis and Treatment

Increased awareness of eye health and early diagnosis initiatives are boosting demand for effective glaucoma treatments. Healthcare professionals are focusing more on preventive measures, leading patients to seek treatment at earlier stages of glaucoma and ocular hypertension[5].

Government Initiatives

Government initiatives aimed at improving access to healthcare and the availability of affordable medications further contribute to the expansion of the latanoprost market[5].

Market Challenges

Patent Expirations

The eventual expiration of patents for brand drugs leads to the entry of generic alternatives, which can reduce the market share and pricing power of original brand drugs. This is a significant challenge in the North American market, where brand drugs currently dominate[2].

Adverse Events

Latanoprost can cause side effects such as eye redness, irritation, and gradual darkening of the iris. Newer drugs like NCX 470, while showing promising results, also come with their own set of adverse events, such as conjunctival/ocular hyperemia[4].

Future Projections

The global latanoprost market is expected to continue growing, driven by the factors mentioned above. Here are some key projections:

• Global Market Size: Expected to reach USD 1.6 billion by 2033, growing at a CAGR of 2.1% from 2024 to 2033[5].

• Regional Growth: North America will continue to be the largest market, while the Asia Pacific region will experience the highest growth rate due to its large and diverse population[2].

• Technological Innovations: Sustained-release formulations and combination therapies will continue to enhance the market, offering improved therapeutic outcomes and better patient compliance[5].

Key Takeaways

• Growing Demand: The latanoprost market is driven by the increasing prevalence of glaucoma and ocular hypertension, especially among the aging population.
• Technological Advancements: Innovations in drug formulations and delivery systems are enhancing the effectiveness and patient compliance of latanoprost.
• Regional Variations: Different regions have varying market dynamics, with North America being the largest market and the Asia Pacific region showing the highest growth potential.
• Challenges: Patent expirations and adverse events are significant challenges that need to be addressed.

FAQs

What is latanoprost used for?

Latanoprost is used to treat increased intraocular pressure associated with conditions such as glaucoma and ocular hypertension.

How does latanoprost work?

Latanoprost works by increasing the outflow of aqueous humor, thereby reducing intraocular pressure.

What are the common side effects of latanoprost?

Common side effects include eye redness, irritation, and gradual darkening of the iris.

What is the current market size of the global latanoprost market?

The global latanoprost market size was estimated to be USD 1.3 billion in 2023.

What is the projected growth rate of the global latanoprost market?

The global latanoprost market is projected to grow at a CAGR of 2.1% from 2024 to 2033.

Which region has the highest growth potential for latanoprost?

The Asia Pacific region has the highest growth potential, driven by its large and diverse population and increasing prevalence of glaucoma and ocular hypertension.

Sources

1. Patsnap Synapse: Latanoprost - Drug Targets, Indications, Patents.
2. Cognitive Market Research: Latanoprost Market Report 2024.
3. pSivida: pSivida Announces Phase I/II Clinical Study Evaluating Bioerodible, Sustained Release Latanoprost Device.
4. Ophthalmology Times: Nicox publishes results of Phase 3 trial of NCX 470 for treatment of glaucoma.
5. Allied Market Research: Latanoprost Market Size, Report | Industry Analysis, 2033.