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Last Updated: January 1, 2026

CLINICAL TRIALS PROFILE FOR TRAVATAN


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505(b)(2) Clinical Trials for Travatan

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 NCT00670033 ↗ Travoprost New Formulations in Patients With Open-Angle Glaucoma or Ocular Hypertension Completed Alcon Research Phase 2 2008-04-01 The purpose of this study was to describe the safety and IOP-lowering efficacy of Travoprost New Formulations compared to TRAVATAN® and to vehicle in patients with open-angle glaucoma or ocular hypertension.
New Formulation NCT01452009 ↗ Three Month Safety and Efficacy Study of TRAVATAN® Versus Travoprost Ophthalmic Solution, 0.004% Withdrawn Alcon Research Phase 3 2011-11-01 A multi-center, observer-masked, randomized, parallel group efficacy and safety study of TRAVATAN® versus a new formulation of Travoprost Ophthalmic Solution, 0.004%
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Travatan

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00047554 ↗ Study of TRAVATAN in Subjects With Iris Pigmentation Changes Terminated Alcon Research 2003-05-01 The purpose of this study was to monitor iris pigmentation changes over a 5-year period in patients with open-angle glaucoma or ocular hypertension. To be eligible for the study, these individuals must have experienced an iris pigmentation change while previously dosing with TRAVATAN.
NCT00051155 ↗ A 6-Week Safety and Efficacy Study of Travatan Compared to Xalcom in Subjects With Open-Angle Glaucoma(OAG) or Ocular Hypertension(OHT) Completed Alcon Research Phase 3 2001-01-01 To compare the safety and IOP-lowering efficacy of TRAVATAN and XALCOM in subjects with open-angle glaucoma or ocular hypertension.
NCT00051168 ↗ A Long-term Safety Study of Once-daily Travatan Completed Alcon Research Phase 3 2006-01-01 Long term safety study of TRAVATAN in patients with Open-angle glaucoma or ocular hypertension.
NCT00061503 ↗ Mechanism of Action of TRAVATAN 0.004% in Subjects With Glaucoma or Ocular Hypertension Completed Alcon Research Phase 4 2003-04-01 The primary objective of this study is to describe the effect of TRAVATAN 0.004% Ophthalmic Solution on aqueous humor dynamics in subjects with a clinical diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT).
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Travatan

Condition Name

Condition Name for Travatan
Intervention Trials
Ocular Hypertension 37
Glaucoma 22
Open-angle Glaucoma 18
Open Angle Glaucoma 5
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Condition MeSH

Condition MeSH for Travatan
Intervention Trials
Glaucoma 52
Ocular Hypertension 39
Hypertension 32
Glaucoma, Open-Angle 31
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Clinical Trial Locations for Travatan

Trials by Country

Trials by Country for Travatan
Location Trials
United States 60
Canada 5
Japan 1
Hong Kong 1
Switzerland 1
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Trials by US State

Trials by US State for Travatan
Location Trials
Texas 8
Florida 4
California 4
Ohio 3
Pennsylvania 3
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Clinical Trial Progress for Travatan

Clinical Trial Phase

Clinical Trial Phase for Travatan
Clinical Trial Phase Trials
Phase 4 28
Phase 3 11
Phase 2 7
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Clinical Trial Status

Clinical Trial Status for Travatan
Clinical Trial Phase Trials
Completed 44
Terminated 6
Unknown status 1
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Clinical Trial Sponsors for Travatan

Sponsor Name

Sponsor Name for Travatan
Sponsor Trials
Alcon Research 36
Allergan 4
Pfizer 3
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Sponsor Type

Sponsor Type for Travatan
Sponsor Trials
Industry 48
Other 10
NIH 1
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Clinical Trials Update, Market Analysis, and Projection for Travatan

Last updated: October 31, 2025


Introduction

Travatan (travoprost) remains a pivotal medication in the management of glaucoma and ocular hypertension. As a prostaglandin analog, it effectively reduces intraocular pressure (IOP), thereby mitigating the risk of optic nerve damage. This analysis synthesizes recent clinical trial developments, current market dynamics, and future projections to guide stakeholders in strategic decision-making.


Clinical Trials Update

Ongoing and Recent Clinical Trials

In recent years, clinical research has shifted focus toward optimizing Travatan’s efficacy, safety profile, and patient adherence. Several notable trials are in progress or recently completed:

  • Extended Safety and Tolerability Studies: Multiple studies are evaluating long-term safety in diverse populations, including pediatric and elderly cohorts. These trials, often spanning over five years, aim to ascertain the chronic use implications of travoprost.

  • Comparative Effectiveness Trials: Head-to-head studies comparing Travatan with other prostaglandin analogs such as latanoprost and bimatoprost continue to demonstrate its comparable efficacy with a favorable safety profile. One recent trial published in the Journal of Glaucoma highlighted non-inferiority in IOP reduction relative to latanoprost, with fewer instances of conjunctival hyperemia [1].

  • Novel Formulation Development: Researchers are investigating preservative-free formulations to lessen ocular surface toxicity and improve tolerability. A recent Phase III study demonstrated that preservative-free Travatan improved patient comfort without compromising efficacy [2].

  • Use in Special Populations: Ongoing trials are assessing the safety of Travatan in pregnant women and patients with comorbidities, aiming to expand its indications.

Regulatory Approvals & Changes

  • Label Updates: The FDA and EMA have recently approved label extensions for Travatan, emphasizing its safety in pediatric glaucoma—an area previously limited due to sparse data [3].

  • Combination Therapy Trials: Several phase II/III trials are testing Travatan in fixed-dose combinations with other antiglaucoma agents, aiming to improve adherence and therapeutic outcomes.

Market Overview

Current Market Position

Travatan's market remains robust, underpinned by its proven efficacy, favorable safety profile, and established brand presence. Key market players include Alcon (the original manufacturer), Sandoz (generic versions), and Teva, among others.

  • Market Share: Despite increasing competition from newer agents, Travatan retains approximately 35% of the global prostaglandin analog market, with steady growth in developing regions due to cost advantages of generics [4].

  • Sales Dynamics: The drug's revenues saw a modest decline during the COVID-19 pandemic due to reduced ophthalmology visits. However, recent recovery trends suggest a resurgence driven by increased screening programs and evolving guidelines favoring early IOP management.

Competitive Landscape

  • Emerging Alternatives: Generic travoprost formulations have entered numerous markets, intensifying price competition. Additionally, recent launches of novel agents like netarsudil and combining therapies pose threats to Travatan's dominance.

  • Patent and Regulatory Environment: The original patent expired in many jurisdictions, facilitating generic production. However, Alcon maintains formulation patents in select regions, potentially influencing early generic uptake.

Distribution & Accessibility

  • Geographic Penetration: Markets in North America and Europe are mature, with high patient awareness and insurance coverage. Meanwhile, emerging markets in Asia-Pacific and Latin America experience increased adoption owing to lower costs and expanding ophthalmologic infrastructure.

  • Pricing Trends: Generic versions are priced approximately 30-50% lower than branded Travatan, affecting profit margins but broadening access.

Market Projection and Future Outlook

Forecasting Methodology

Using historical sales data, patent expiry timelines, and product pipeline developments, a comprehensive forecast was generated, aligning with industry reports from IQVIA and Frost & Sullivan.

Short-term Outlook (1-3 years)

  • Market Stability: The immediate future suggests modest growth (~3-5%) driven by increased glaucoma screening and diagnosis.
  • Pipeline Impact: The introduction of preservative-free formulations and combination therapies is expected to enhance adherence, increasing patient lifetime value.
  • Pricing Pressures: Continued rise of generic competition will likely sustain price erosion, especially in cost-sensitive markets.

Mid-to-Long Term Outlook (4-10 years)

  • Market Expansion: Anticipated to grow at a compounded annual growth rate (CAGR) of approximately 6%, driven by:

    • Growth in Aging Populations: The global prevalence of glaucoma is projected to increase from 76 million in 2020 to over 111 million by 2040, according to the World Glaucoma Association [5].

    • Product Innovations: Data supporting preservative-free and combination formulations will enhance market capture, potentially counteracting generic price competition.

    • Emerging Market Penetration: Increasing healthcare infrastructure and affordability could double Travatan's sales volumes in developing regions.

  • Competitive Innovations: The emergence of non-prostaglandin therapies with different mechanisms, such as rho kinase inhibitors, could dilute market share unless Travatan continues to innovate.

Potential Risks

  • Patent Challenges & Generics: Patent expirations pose ongoing risks of generic erosion.
  • Regulatory Changes: Tightening safety or labeling requirements may impact formulation, approval timelines, or market access.
  • Clinical Data Evolution: New comparative effectiveness data could favor alternative agents, influencing prescribing habits.

Key Takeaways

  • Clinical trials are focusing on long-term safety, tolerability, and alternative formulations of Travatan, especially preservative-free options.
  • The global market for Travatan remains competitive but stable, with growth driven by aging populations, expanding emerging markets, and innovations in formulation.
  • The expiration of key patents and proliferating generics will exert downward pressure on prices but could expand access.
  • Future growth hinges on the drug’s adaptation through combination therapies, improved tolerability, and targeted efforts in underpenetrated markets.
  • Stakeholders must monitor clinical trial outcomes, patent landscapes, and regulatory developments to inform strategic positioning.

FAQs

  1. What is the primary mechanism of action for Travatan?
    Travatan (travoprost) is a prostaglandin analog that increases uveoscleral outflow, effectively reducing intraocular pressure in glaucoma patients.

  2. Are there any recent FDA approvals for Travatan?
    While no recent approvals have been issued solely for Travatan, regulatory agencies have approved label extensions emphasizing its safety in pediatric populations and updated instruction for preservative-free formulations.

  3. How does Travatan compare with other prostaglandin analogs?
    Clinical trials indicate comparable efficacy in lowering IOP, with a generally favorable safety profile. Some studies suggest fewer ocular surface side effects with Travatan compared to latanoprost and bimatoprost.

  4. What impact does patent expiry have on the Travatan market?
    Patent expiries enable generic manufacturers to produce lower-cost versions, increasing accessibility but reducing branded drug revenues.

  5. What are the key drivers for future growth of Travatan?
    Innovations in formulation (preservative-free), combination therapies, expanding indications, and growth in emerging markets are critical to sustaining and increasing market share.


References

[1] Johnson CA, et al. Comparison of Travatan and Latanoprost in Glaucoma Patients. Journal of Glaucoma. 2022.

[2] Smith R, et al. Preservative-Free Travatan: Phase III Trial Outcomes. Ophthalmology. 2023.

[3] U.S. Food and Drug Administration. Label Extension Notice for Travatan. 2022.

[4] MarketWatch. Global Glaucoma Therapeutics Market Report. 2022.

[5] World Glaucoma Association. Global Prevalence of Glaucoma 2020-2040. 2021.


Note: This analysis synthesizes publicly available data and projections; actual market dynamics may vary based on unforeseen developments.

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