CLINICAL TRIALS PROFILE FOR TIMOPTIC

All Clinical Trials for Timoptic

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00368602 ↗	Beta Blocker for Chronic Wound Healing	Terminated	University of California, Davis	Phase 2	2005-06-01	The purpose of this study is to evaluate the efficacy and safety of treatment of chronic cutaneous ulcers and burn wounds with topical beta adrenergic antagonists (Timoptic®).
NCT00763061 ↗	Travatan Versus Timoptic in Treating Open-angle Glaucoma or Ocular Hypertension	Completed	Alcon Research	Phase 4	2006-05-01	To evaluate the Intraocular Pressure (IOP) lowering efficacy and safety of Travoprost 0.004% compared to Timolol 0.5% in patients with open-angle glaucoma (OAG) or ocular hypertension (OH). The study structure is a parallel design. The patients will receive treatment for 12 weeks.
NCT00804115 ↗	The International Collaborative Exfoliation Syndrome Treatment Study	Unknown status	Pfizer	N/A	2000-08-01	Purpose: To determine the efficacy of treatment with latanoprost in combination with pilocarpine versus timolol or timolol/dorzolamide fixed combination (Timoptic or Cosopt) in eyes with XFS and elevated intraocular pressure (IOP). Methods: This is a randomized, open-label study to test the hypothesis that improving both pressure-dependent and pressure-independent aqueous outflow and minimizing iridolenticular friction will interfere with the progression of XFS, allow improvement in trabecular function, and be more effective over time than simply reducing aqueous formation. Randomization was performed across the centers, per patient rather than per eye to avoid any crossover effect caused by aqueous suppressants. Group I was treated with latanoprost and pilocarpine, both in the evening, and Group II with Timolol or Cosopt b.i.d. Only one eye per patient was randomized. Patients were followed for 2 years with assessment of IOP, visual field progression, tonographic outflow coefficient and trabecular pigmentation at the 6:00 and 12:00 position.
NCT00804115 ↗	The International Collaborative Exfoliation Syndrome Treatment Study	Unknown status	The New York Eye & Ear Infirmary	N/A	2000-08-01	Purpose: To determine the efficacy of treatment with latanoprost in combination with pilocarpine versus timolol or timolol/dorzolamide fixed combination (Timoptic or Cosopt) in eyes with XFS and elevated intraocular pressure (IOP). Methods: This is a randomized, open-label study to test the hypothesis that improving both pressure-dependent and pressure-independent aqueous outflow and minimizing iridolenticular friction will interfere with the progression of XFS, allow improvement in trabecular function, and be more effective over time than simply reducing aqueous formation. Randomization was performed across the centers, per patient rather than per eye to avoid any crossover effect caused by aqueous suppressants. Group I was treated with latanoprost and pilocarpine, both in the evening, and Group II with Timolol or Cosopt b.i.d. Only one eye per patient was randomized. Patients were followed for 2 years with assessment of IOP, visual field progression, tonographic outflow coefficient and trabecular pigmentation at the 6:00 and 12:00 position.
NCT00815373 ↗	The Effects of Cosopt® Vs Xalacom® on Ocular Hemodynamics and Intraocular Pressure (IOP) in Primary Open-angle Glaucoma (POAG)	Withdrawn	Meir Medical Center	N/A	2008-12-01	Both Cosopt® and Xalatan® plus Timoptic® will significantly lower IOP, however only Cosopt® will demonstrate positive hemodynamic effects. The clinical significance of this will be investigated by examining the ophthalmic and short posterior ciliary arteries to determine the blood supply to the optic nerve head, the site of damage in glaucoma
NCT00856622 ↗	A Study Demonstrating The Effect Of Latanoprost In Combination With Timolol, Latanoprost Alone And Timolol Alone On Eye Pressure In Open Angle Glaucoma Or Ocular Hypertension In Patients	Completed	Pfizer	Phase 3	1997-08-01	The purpose of this study is to demonstrate that fixed combination of latanoprost and timolol (PhXA41) has better IOP lowering effect than the individual monotherapies.
NCT00856622 ↗	A Study Demonstrating The Effect Of Latanoprost In Combination With Timolol, Latanoprost Alone And Timolol Alone On Eye Pressure In Open Angle Glaucoma Or Ocular Hypertension In Patients	Completed	Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	Phase 3	1997-08-01	The purpose of this study is to demonstrate that fixed combination of latanoprost and timolol (PhXA41) has better IOP lowering effect than the individual monotherapies.

Clinical Trial Conditions for Timoptic

Condition Name

Condition Name for Timoptic
Intervention	Trials
Ocular Hypertension	5
Glaucoma	5
Primary Open-Angle Glaucoma (POAG)	2
Ocular Hypertension (OHT)	2

Condition MeSH

Condition MeSH for Timoptic
Intervention	Trials
Glaucoma	12
Ocular Hypertension	9
Glaucoma, Open-Angle	8
Hypertension	8

Clinical Trial Locations for Timoptic

Trials by Country

Trials by Country for Timoptic
Location	Trials
United States	21
Korea, Republic of	1
Iran, Islamic Republic of	1
Germany	1
Austria	1

Trials by US State

Trials by US State for Timoptic
Location	Trials
California	6
Texas	3
Missouri	2
Ohio	2
Michigan	1

Clinical Trial Progress for Timoptic

Clinical Trial Phase

Clinical Trial Phase for Timoptic
Clinical Trial Phase	Trials
Phase 4	4
Phase 3	5
Phase 2	4

Clinical Trial Status

Clinical Trial Status for Timoptic
Clinical Trial Phase	Trials
Completed	9
Unknown status	4
Withdrawn	2

Clinical Trial Sponsors for Timoptic

Sponsor Name

Sponsor Name for Timoptic
Sponsor	Trials
Pfizer	2
Inotek Pharmaceuticals Corporation	2
Seoul National University Hospital	1

Sponsor Type

Sponsor Type for Timoptic
Sponsor	Trials
Other	13
Industry	12
U.S. Fed	2

TIMOPTIC: Clinical Trials, Market Analysis, and Projections

Introduction to TIMOPTIC

TIMOPTIC, commonly known by its generic name timolol, is a beta-blocker medication widely used in the treatment of glaucoma and ocular hypertension. It works by reducing the production of aqueous humor in the eye, thereby lowering intraocular pressure (IOP).

Clinical Trials and Efficacy

Comparison with Other Treatments

TIMOPTIC has been extensively studied in clinical trials to evaluate its safety and efficacy. For instance, the FDA's Drug Trials Snapshot for OMLONTI compares the efficacy of OMLONTI with timolol 0.5% twice daily. These multicenter, double-masked, randomized, parallel-group, active-controlled, non-inferiority studies involved 1,203 patients with open-angle glaucoma (OAG) or ocular hypertension (OHT). The results showed that timolol remains a viable and effective treatment option, although new treatments like OMLONTI are being developed to offer alternative therapies[3].

Recent Studies and Devices

In recent clinical trials, TIMOPTIC has been used as a control therapy to compare the efficacy of new devices and treatments. For example, Glaukos's iDose TR, a biocompatible titanium implant that releases travoprost, was compared against timolol eye drops in phase 3 trials. These trials demonstrated that the implant was noninferior to timolol in reducing IOP, highlighting the ongoing innovation in glaucoma treatment while affirming timolol's efficacy[4].

Market Analysis

Market Size and Growth

The global market for timolol is significant and growing. The market size is driven by the increasing prevalence of hypertension and glaucoma, particularly among the geriatric population. As of the forecast period from 2025 to 2033, the timolol market is expected to grow at a steady CAGR, with the market valued in millions of US dollars[2].

Regional Dominance

North America and Europe currently dominate the timolol market, but emerging regions such as Asia Pacific and Latin America are expected to experience significant growth. The Asia Pacific region, in particular, is anticipated to witness rapid growth due to the increasing burden of ophthalmic disorders and rising consumer awareness[2][5].

Key Players and Market Trends

Leading pharmaceutical companies such as Pfizer, Allergan, and Merck & Co, Inc. hold a substantial market share in the timolol market. The introduction of generic formulations has enhanced accessibility and affordability, contributing to the market's growth. Additionally, there has been significant merger and acquisition activity in the timolol market, driven by the desire of pharmaceutical companies to expand their product portfolios and gain access to new markets[2].

Market Projections

Future Growth Drivers

The growth of the timolol market is expected to be driven by several key factors:

• Increasing Prevalence of Hypertension and Glaucoma: The rising incidence of these conditions, especially among older populations, will continue to drive demand for timolol.
• Growing Awareness: Increased awareness of the benefits of timolol and other ophthalmic treatments will contribute to market growth.
• Expanding Access to Healthcare: Improvements in healthcare infrastructure and access to affordable healthcare in emerging markets will further boost the market[2].

Regional Growth

Asia Pacific is expected to be a key growth region, driven by the development of novel technologies and the presence of a well-distributed network of clinical laboratories and hospitals. Countries like China and India are at the forefront of this growth, with significant investments in healthcare facilities and research[5].

Competitive Landscape

New Treatments and Devices

The ophthalmic drugs market is witnessing the introduction of new treatments and devices, such as the Tixel i for dry eye disease and the iDose TR implant for glaucoma. These innovations are expected to provide alternative treatment options but do not necessarily replace timolol, given its established efficacy and safety profile[1][4].

Patient Demographics

Primary End Users

The primary end users of timolol are individuals over the age of 65, who are more likely to develop glaucoma and hypertension. This demographic trend is expected to continue, driving the demand for timolol and other ophthalmic treatments[2].

Conclusion

TIMOPTIC remains a cornerstone in the treatment of glaucoma and ocular hypertension, with a strong market presence and projected growth. The increasing prevalence of eye diseases, growing awareness, and expanding access to healthcare are key drivers of this growth. While new treatments and devices are being developed, timolol's efficacy and safety ensure its continued relevance in the ophthalmic drugs market.

Key Takeaways

• Established Efficacy: TIMOPTIC has been extensively studied and proven effective in reducing IOP.
• Market Growth: The timolol market is expected to grow at a steady CAGR from 2025 to 2033.
• Regional Dominance: North America and Europe currently dominate, but Asia Pacific is expected to witness rapid growth.
• New Treatments: Innovations like the iDose TR implant provide alternative treatment options but do not replace timolol.
• Patient Demographics: Individuals over 65 are the primary end users, driving demand due to higher incidence of glaucoma and hypertension.

FAQs

What is TIMOPTIC used for?

TIMOPTIC, or timolol, is used to treat glaucoma and ocular hypertension by reducing intraocular pressure.

How does TIMOPTIC compare to new treatments?

TIMOPTIC remains effective and is often used as a control therapy in clinical trials for new treatments, such as the iDose TR implant, which has shown noninferiority to timolol in reducing IOP.

What are the key drivers of the timolol market growth?

The key drivers include the increasing prevalence of hypertension and glaucoma, growing awareness of the benefits of timolol, and expanding access to affordable healthcare.

Which regions are expected to dominate the timolol market?

North America and Europe currently dominate, but the Asia Pacific region is expected to experience significant growth due to increasing demand and improving healthcare infrastructure.

What is the projected growth rate of the timolol market?

The timolol market is expected to grow at a steady CAGR from 2025 to 2033, driven by several key factors including increasing prevalence of eye diseases and growing awareness.

References

1. FDA Alerts: New Optometry Drugs and Devices - Optometry Advisor
2. Timolol: Competitive Landscape and Growth Trends 2025-2033 - Data Insights Market
3. Drug Trials Snapshot: OMLONTI - FDA
4. Glaukos beats path to FDA after eye implant trials hit goals - FiercePharma
5. Ophthalmic Drugs Market Size & Share | Industry Report 2030 - Grand View Research