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Last Updated: February 11, 2025

CLINICAL TRIALS PROFILE FOR COSOPT


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All Clinical Trials for Cosopt

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.
NCT00273429 ↗ Cosopt Versus Xalatan Completed Pharmaceutical Research Network Phase 4 2005-04-01 To compare the 24-hour efficacy and safety, measured every three hours, of the dorzolamide/timolol fixed combination given twice daily versus latanoprost and placebo each given once daily.
NCT00273442 ↗ Assessing Cosopt Switch Patients Completed Pharmaceutical Research Network Phase 4 2005-11-01 To assess the safety and efficacy of a cohort of patients switched to the dorzolamide/timolol maleate fixed combination because they are insufficiently controlled on latanoprost monotherapy.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Cosopt

Condition Name

Condition Name for Cosopt
Intervention Trials
Ocular Hypertension 19
Glaucoma 15
Open-angle Glaucoma 10
Open Angle Glaucoma 2
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Condition MeSH

Condition MeSH for Cosopt
Intervention Trials
Glaucoma 27
Ocular Hypertension 20
Glaucoma, Open-Angle 15
Hypertension 15
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Clinical Trial Locations for Cosopt

Trials by Country

Trials by Country for Cosopt
Location Trials
United States 23
Canada 4
Greece 3
Mexico 2
Italy 2
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Trials by US State

Trials by US State for Cosopt
Location Trials
Pennsylvania 3
Massachusetts 3
South Carolina 2
Illinois 2
Michigan 2
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Clinical Trial Progress for Cosopt

Clinical Trial Phase

Clinical Trial Phase for Cosopt
Clinical Trial Phase Trials
Phase 4 18
Phase 3 5
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Cosopt
Clinical Trial Phase Trials
Completed 28
Unknown status 4
Terminated 2
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Clinical Trial Sponsors for Cosopt

Sponsor Name

Sponsor Name for Cosopt
Sponsor Trials
Alcon Research 9
Merck Sharp & Dohme Corp. 6
Pharmaceutical Research Network 4
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Sponsor Type

Sponsor Type for Cosopt
Sponsor Trials
Other 24
Industry 23
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Clinical Trials, Market Analysis, and Projections for Cosopt

Introduction

Cosopt, a combination ophthalmic solution of dorzolamide hydrochloride and timolol maleate, is widely used for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Here, we will delve into the clinical trials, market analysis, and future projections for this medication.

Clinical Trials Overview

Efficacy and Safety

Clinical studies conducted over 3 to 15 months compared the intraocular pressure (IOP)-lowering effects of Cosopt administered twice daily against monotherapy with either 2.0% dorzolamide or 0.5% timolol, as well as against concomitant therapy with both drugs. These studies showed that Cosopt administered twice daily had a greater IOP-lowering effect than monotherapy with either drug alone, although it was slightly less effective than the concomitant administration of both drugs[1][4].

Long-Term Efficacy

Open-label extensions of two studies were conducted for up to 12 months, demonstrating that the IOP-lowering effect of Cosopt remained consistent over this period. This long-term efficacy is crucial for managing chronic conditions like glaucoma[1].

Preservative-Free Formulation

The preservative-free version of Cosopt, known as Cosopt PF, was also evaluated. Preclinical pharmacodynamics studies showed that the removal of the preservative did not alter the ocular hypotensive effect of the solution. This formulation is particularly beneficial for patients who are sensitive to preservatives[4].

Market Analysis

Current Market Performance

Santen Pharmaceutical, a major player in the ophthalmic market, has seen significant growth driven by its glaucoma and dry eye products, including Cosopt. In fiscal 2022, revenue from these products contributed to a 22% year-on-year growth in major markets such as South Korea and Thailand[2].

Regional Performance

The Asia region, particularly countries like Vietnam, Thailand, and South Korea, has been a strong market for Cosopt. Santen aims to further expand its market share in these regions through the introduction of new products and adherence programs like the ACT Pack glaucoma treatment adherence program[2].

Market Challenges

Despite the growth, the market faces challenges such as drug reimbursement price reductions, increased competition from generics, and stricter regulatory reviews. These factors can impact sales and revenue, especially in regions with deteriorating national health insurance finances[2].

Market Projections

Growth Drivers

The ophthalmic market, particularly the glaucoma segment, is expected to grow driven by an aging population and increasing disease awareness. New product launches, such as Diquas LX and the ophthalmic cream formulation of Alesion, are anticipated to contribute to this growth. Additionally, initiatives to improve treatment adherence and the development of the ophthalmic ecosystem are expected to drive market expansion[2].

Revenue Forecasts

For fiscal 2023, Santen forecasts revenue of JPY 26.1 billion, up 8% year on year, mainly due to growth in major markets centered on mainstay products like Cosopt. Over the medium-term management plan through fiscal 2025, the company aims to achieve double-digit growth that exceeds market growth by improving treatment adherence rates and expanding sales channels[2].

Market Expansion Strategies

Santen plans to strengthen its business base in China and other key markets by leveraging internal and external resources. The company will focus on obtaining a leading position in prescription pharmaceuticals for dry eye and developing the ecosystem for glaucoma and dry eye treatments. This includes promoting the concept of dry eye treatments and tapping into the OTC market for self-medication in Southeast Asia[2].

Key Takeaways

  • Clinical Efficacy: Cosopt has demonstrated superior IOP-lowering effects compared to monotherapy and consistent long-term efficacy.
  • Market Performance: The drug has contributed significantly to the growth of Santen Pharmaceutical in key markets.
  • Growth Drivers: An aging population, new product launches, and initiatives to improve treatment adherence are expected to drive market growth.
  • Challenges: The market faces challenges from generics, reimbursement price reductions, and regulatory changes.
  • Projections: Double-digit growth is anticipated through fiscal 2025, driven by expanded sales channels and improved treatment adherence.

FAQs

Q: What is Cosopt used for?

A: Cosopt is used for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

Q: How does Cosopt compare to monotherapy with dorzolamide or timolol?

A: Clinical studies show that Cosopt administered twice daily has a greater IOP-lowering effect than monotherapy with either 2.0% dorzolamide or 0.5% timolol.

Q: What is the significance of the preservative-free formulation of Cosopt?

A: The preservative-free version, Cosopt PF, is beneficial for patients sensitive to preservatives and maintains the same ocular hypotensive effect as the original formulation.

Q: Which regions are key markets for Cosopt?

A: The Asia region, particularly countries like Vietnam, Thailand, and South Korea, are strong markets for Cosopt.

Q: What are the main challenges facing the market for Cosopt?

A: The market faces challenges from drug reimbursement price reductions, increased competition from generics, and stricter regulatory reviews.

Sources

  1. COSOPT - accessdata.fda.gov
  2. Overview by Region - Santen Pharmaceutical
  3. Plaque Psoriasis Drug Forecast and Market Analysis to 2030 - GlobeNewswire
  4. 202667Orig1s000 - accessdata.fda.gov

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