CLINICAL TRIALS PROFILE FOR TRAVATAN

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NCT01452009 ↗	Three Month Safety and Efficacy Study of TRAVATAN® Versus Travoprost Ophthalmic Solution, 0.004%	Withdrawn	Alcon Research	Phase 3	2011-11-01	A multi-center, observer-masked, randomized, parallel group efficacy and safety study of TRAVATAN® versus a new formulation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%

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).
NCT00121147 ↗	Additivity Study: Additive Effect on Eye Pressure of Azopt and Alphagan P to Travatan	Completed	Alcon Research	N/A	2003-09-01	The purpose of this study is to compare the additive effect on eye pressure of Azopt and Alphagan P to Travatan.
NCT00121147 ↗	Additivity Study: Additive Effect on Eye Pressure of Azopt and Alphagan P to Travatan	Completed	Hermann Eye Center	N/A	2003-09-01	The purpose of this study is to compare the additive effect on eye pressure of Azopt and Alphagan P to Travatan.
NCT00293761 ↗	A Study of Glaucoma Therapy to Treat Open-Angle Glaucoma or Ocular Hypertension	Completed	Alcon Research	Phase 3	2006-01-01	The purpose of the study is to determine whether a glaucoma therapy is safe and effective in treating patients with open-angle glaucoma or ocular hypertension

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

Condition MeSH

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

Clinical Trial Locations for Travatan

Trials by Country

Trials by Country for Travatan
Location	Trials
United States	60
Canada	5
Belgium	1
Korea, Republic of	1
Portugal	1

Trials by US State

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

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

Clinical Trial Status

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

Clinical Trial Sponsors for Travatan

Sponsor Name

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

Sponsor Type

Sponsor Type for Travatan
Sponsor	Trials
Industry	48
Other	10
NIH	1

TRAVATAN: Clinical Trials, Market Analysis, and Projections

Introduction to TRAVATAN

TRAVATAN, also known as travoprost, is a prostaglandin analogue used to reduce intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Here, we will delve into the recent clinical trials, market analysis, and future projections for this medication.

Clinical Trials Overview

Phase 3 Trials for iDose TR

A significant development in the use of travoprost is the FDA approval of the iDose TR (travoprost intracameral implant) by Glaukos. The approval is based on two Phase 3 pivotal trials (GC-010 and GC-012) that compared the safety and efficacy of iDose TR with topical timolol ophthalmic solution. These trials involved 1,150 subjects across 89 clinical sites and demonstrated that iDose TR achieved non-inferiority to timolol in reducing IOP over the first three months. The slow-release iDose TR model showed IOP reductions of 6.6-8.4 mmHg, comparable to the 6.5-7.7 mmHg reduction seen with timolol[1].

Traditional Travoprost Trials

Traditional travoprost formulations, such as Travatan, have been extensively studied in various clinical trials. These trials have compared travoprost with timolol and other prostaglandin analogues. For instance, Travatan was studied in three main trials involving 1,989 adult patients, lasting between six and 12 months, and showed significant reductions in IOP compared to timolol. Additionally, a study in pediatric patients demonstrated similar efficacy and safety profiles to those observed in adults[3][4].

Safety and Efficacy

Efficacy

The efficacy of travoprost in reducing IOP is well-documented. In clinical trials, travoprost has consistently shown reductions in IOP, often comparable to or slightly better than traditional treatments like timolol. The iDose TR implant, in particular, offers a sustained release of travoprost, reducing the need for daily topical medications and maintaining a favorable safety profile over 12 months[1].

Safety

While effective, travoprost is associated with several side effects. Common adverse reactions include ocular hyperaemia, growth of eyelashes, and changes in iris and eyelid pigmentation. Periorbital and eyelid skin darkening, as well as deepening of the eyelid sulcus, have also been reported in a small percentage of patients. These changes are generally reversible upon discontinuation of the medication[4].

Market Analysis

Global Market Size and Forecast

The global market for travoprost is part of the broader anti-glaucoma drug market, which was valued at USD 7.98 billion in 2022 and is projected to reach USD 12.35 billion by 2030. The travoprost segment, specifically, is expected to grow significantly due to its efficacy and the introduction of new delivery systems like the iDose TR implant[5].

Regional Market Breakdown

The market for travoprost is segmented by region, with North America, Europe, and the Asia-Pacific region being key markets. Each of these regions is expected to see growth, driven by increasing awareness of glaucoma, an aging population, and advancements in treatment options. The Asia-Pacific region, in particular, is anticipated to show a high CAGR due to its large and growing population[2].

Key Players

The global travoprost market includes several key players such as Cayman Pharma, FCAD, SALVAVIDAS PHARMACEUTICAL, and others. These companies are involved in the production and distribution of travoprost and are expected to play a crucial role in the market's growth over the next few years[2].

Market Projections

Growth Drivers

The growth of the travoprost market is driven by several factors, including the increasing prevalence of glaucoma, the aging population, and advancements in drug delivery systems. The FDA approval of iDose TR is expected to further boost the market by offering a more convenient and sustained treatment option for patients[1][5].

Challenges and Opportunities

Despite the positive outlook, the market faces challenges such as competition from other anti-glaucoma medications and potential side effects associated with travoprost. However, the introduction of new delivery systems and ongoing research into the safety and efficacy of travoprost are expected to provide opportunities for growth and market expansion.

Commercial Launch and Pricing

iDose TR Commercial Launch

Glaukos plans to commence the initial commercial launch of iDose TR in the latter part of the first quarter of 2024. This launch is expected to significantly impact the market by offering a novel treatment option that reduces the burden of daily topical medications[1].

Pricing

The wholesale acquisition cost for iDose TR has been set at $13,950 per dose (or implant). This pricing reflects the value of the sustained release and convenience offered by the implant, which could potentially reduce long-term healthcare costs associated with managing glaucoma[1].

Key Takeaways

• Clinical Efficacy: Travoprost, including the iDose TR implant, has demonstrated significant reductions in IOP in clinical trials, comparable to or better than traditional treatments.
• Safety Profile: While effective, travoprost is associated with several side effects, including changes in iris and eyelid pigmentation and growth of eyelashes.
• Market Growth: The global market for travoprost is expected to grow significantly, driven by increasing awareness of glaucoma, an aging population, and advancements in treatment options.
• Regional Markets: North America, Europe, and the Asia-Pacific region are key markets, with the Asia-Pacific region expected to show high growth.
• Commercial Launch: The iDose TR implant is set to launch in the first quarter of 2024, offering a novel treatment option with a wholesale acquisition cost of $13,950 per dose.

FAQs

What is TRAVATAN used for?

TRAVATAN, or travoprost, is used to reduce intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

What are the key findings from the iDose TR clinical trials?

The iDose TR clinical trials showed that the implant achieved non-inferiority to timolol in reducing IOP over the first three months, with a favorable safety profile over 12 months.

What are the common side effects of travoprost?

Common side effects include ocular hyperaemia, growth of eyelashes, and changes in iris and eyelid pigmentation.

What is the projected market size for the anti-glaucoma drug market by 2030?

The anti-glaucoma drug market is projected to reach USD 12.35 billion by 2030.

When is the commercial launch of iDose TR expected?

The commercial launch of iDose TR is expected in the latter part of the first quarter of 2024.

Sources

1. Glaukos Announces FDA Approval of iDose®TR (travoprost intracameral implant): https://investors.glaukos.com/investors/news/news-details/2023/Glaukos-Announces-FDA-Approval-of-iDoseTR-travoprost-intracameral-implant/default.aspx
2. Travoprost - Global Market Share and Ranking, Overall Sales and Demand Forecast 2024-2030: https://www.qyresearch.com/reports/2526710/travoprost
3. Travatan | European Medicines Agency (EMA): https://www.ema.europa.eu/en/medicines/human/EPAR/travatan
4. Travatan, INN-travoprost - European Medicines Agency: https://www.ema.europa.eu/en/documents/product-information/travatan-epar-product-information_en.pdf
5. Anti-Glaucoma Drug Market Key Drivers and Forecast 2025-2032: https://github.com/saya133/Grand-View-Research-Hub/blob/main/Anti-Glaucoma%20Drug%20Market%20Key%20Drivers%20and%20Forecast%202025-2032.md