CLINICAL TRIALS PROFILE FOR BRIMONIDINE TARTRATE

All Clinical Trials for Brimonidine Tartrate

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00061529 ↗	A Phase III Study of Brimonidine Tartrate Ophthalmic Solution, 0.15% in Patients With Open-Angle Glaucoma or Ocular Hypertension	Completed	Alcon Research	Phase 3	2003-01-01	The primary objective of this study is to compare the safety and efficacy of Brimonidine Tartrate Ophthalmic Solution, 0.15% in patients with open-angle glaucoma or ocular hypertension.
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.
NCT00312416 ↗	Effects of Topical Clonidine vs. Brimonidine on Choroidal Blood Flow and Intraocular Pressure During Isometric Exercise	Completed	Medical University of Vienna	Phase 4	2004-02-01	Brimonidine tartrate is an alpha-2 agonist ocular hypotensive drug that exerts its effect by causing both a decrease in aqueous production and an increase in uveoscleral outflow. It has been proven to reduce increased intraocular pressure in glaucoma and ocular hypertension. As an alpha 2 agonist Brimonidine belongs to the same class of drugs as Clonidine; however, its molecular structure is sufficiently different to make it more selective for the alpha 2 receptor than Clonidine. Unlike Clonidine, Brimonidine does not appear to have an effect on the central nervous system and therefore does not cause sedation or systemic hypotension. In addition to their known effect of lowering intraocular pressure, alpha 2 adrenoceptor agonists are neuroprotective. It has, however, been shown that Brimonidine is a very potent vasoconstrictor in the ciliary body thus reducing aqueous humor production. Little is, however, known about potential vasoconstrictor effects of Brimonidine in the posterior pole of the eye. This is of clinical importance, because optic nerve head ischemia appears to contribute to glaucoma pathophysiology. This study is performed to investigate the effects of topical Clonidine vs. topical Brimonidine on choroidal blood flow and intraocular pressure during isometric exercise.

Clinical Trial Conditions for Brimonidine Tartrate

Condition Name

Condition Name for Brimonidine Tartrate
Intervention	Trials
Ocular Hypertension	14
Glaucoma	9
Glaucoma, Open-Angle	7
Hyperemia	3

Condition MeSH

Condition MeSH for Brimonidine Tartrate
Intervention	Trials
Glaucoma	21
Ocular Hypertension	15
Glaucoma, Open-Angle	14
Hypertension	13

Clinical Trial Locations for Brimonidine Tartrate

Trials by Country

Trials by Country for Brimonidine Tartrate
Location	Trials
United States	91
Korea, Republic of	4
Brazil	4
India	3
United Kingdom	3

Trials by US State

Trials by US State for Brimonidine Tartrate
Location	Trials
Massachusetts	8
Tennessee	7
Pennsylvania	7
California	7
Florida	5

Clinical Trial Progress for Brimonidine Tartrate

Clinical Trial Phase

Clinical Trial Phase for Brimonidine Tartrate
Clinical Trial Phase	Trials
Phase 4	16
Phase 3	16
Phase 2	8

Clinical Trial Status

Clinical Trial Status for Brimonidine Tartrate
Clinical Trial Phase	Trials
Completed	43
Not yet recruiting	6
Withdrawn	2

Clinical Trial Sponsors for Brimonidine Tartrate

Sponsor Name

Sponsor Name for Brimonidine Tartrate
Sponsor	Trials
Allergan	14
Bausch & Lomb Incorporated	6
ORA, Inc.	4

Sponsor Type

Sponsor Type for Brimonidine Tartrate
Sponsor	Trials
Industry	41
Other	25
U.S. Fed	1

Brimonidine Tartrate: Clinical Trials, Market Analysis, and Projections

Introduction to Brimonidine Tartrate

Brimonidine tartrate is an α-2 adrenergic agonist commonly used in ophthalmic solutions to treat various eye conditions, including ocular redness, glaucoma, and presbyopia. Here, we will delve into the clinical trials, market analysis, and future projections for this drug.

Clinical Trials Overview

Safety and Efficacy Studies

Brimonidine tartrate ophthalmic solution, particularly the 0.025% concentration, has undergone extensive clinical trials to evaluate its safety and efficacy. Studies such as those referenced in the FDA's Cross Discipline Team Leader Review have shown that brimonidine tartrate is effective in relieving ocular redness with a satisfactory safety profile.

• Study 11-100-0015: This phase 2 study involved adult and geriatric subjects and demonstrated the safety and efficacy of brimonidine tartrate 0.025% ophthalmic solution used four times daily[1][4].
• Study 13-100-0005: A phase 3 study that evaluated the efficacy and safety of brimonidine tartrate 0.025% ophthalmic solution in adults and geriatric subjects with ocular redness[1][4].
• Study 13-100-0006: This phase 3 study assessed the safety of brimonidine tartrate 0.025% ophthalmic solution in pediatric, adult, and geriatric subjects, further supporting its broad safety profile[1].

Recent and Ongoing Trials

• BRIMOCHOL™ PF Study: Visus Therapeutics is conducting a phase 3 clinical trial evaluating the safety and efficacy of BRIMOCHOL™ PF, a fixed-dose combination of carbachol and brimonidine tartrate, for the treatment of presbyopia. This study compares the combination product against carbachol and brimonidine tartrate monotherapies[3].

Safety Profile

The safety data from these trials and postmarketing surveillance indicate that brimonidine tartrate ophthalmic solution 0.025% is well-tolerated. Common adverse events are typically related to the site of administration and include ocular hyperemia and eye irritation. Serious adverse events are infrequent[1][4].

Market Analysis

Market Size and Growth

The global brimonidine tartrate market has shown significant growth over the years. From 2013 to 2017, the market revenue increased substantially, and it is projected to continue growing with a notable CAGR during the 2018-2023 period[2].

• Regional Market: The market is segmented by regions, with North America, Europe, China, Japan, Middle East & Africa, and India being key contributors. Each region has its own production, consumption, export, and import dynamics[2].

Major Applications

Brimonidine tartrate is used in various ophthalmic applications:

• Ocular Redness: It is widely used to relieve redness of the eye due to minor eye irritations, as seen with the product Lumify™[4].
• Glaucoma: Brimonidine tartrate is also used in combination with other drugs, such as timolol maleate, to reduce intraocular pressure in patients with glaucoma or ocular hypertension[5].
• Presbyopia: The ongoing trials with BRIMOCHOL™ PF aim to improve near visual acuity in presbyopic patients[3].

Market Players

The market includes several major players:

• Bausch & Lomb: Known for their product Lumify™, which is a brimonidine tartrate ophthalmic solution 0.025%[4].
• Upsher-Smith Laboratories: Recently launched a generic equivalent to Combigan®, which is a combination of brimonidine tartrate and timolol maleate[5].
• Visus Therapeutics: Developing BRIMOCHOL™ PF, a fixed-dose combination product[3].

Market Projections

Revenue and Consumption Forecast

The global brimonidine tartrate market is expected to continue its growth trajectory. Here are some key projections:

• Revenue Growth: The market revenue is anticipated to reach significant figures by 2023, driven by increasing demand for ophthalmic treatments and the expansion of product portfolios by major players[2].
• Regional Consumption: North America, Europe, and China are expected to remain key markets, with growing consumption in other regions as well[2].

Competitive Landscape

The competitive landscape is dynamic, with new product launches and strategic partnerships:

• Generic Equivalents: The launch of generic equivalents, such as the one by Upsher-Smith Laboratories, is expected to increase market competition and accessibility[5].
• Innovative Products: The development of combination products like BRIMOCHOL™ PF by Visus Therapeutics is likely to capture a significant market share due to their potential to address multiple ophthalmic conditions[3].

Key Takeaways

• Clinical Trials: Brimonidine tartrate has a robust clinical trial history supporting its safety and efficacy.
• Market Growth: The global market is projected to grow significantly, driven by increasing demand and new product launches.
• Applications: The drug is used in various ophthalmic applications, including ocular redness, glaucoma, and presbyopia.
• Market Players: Major players like Bausch & Lomb, Upsher-Smith Laboratories, and Visus Therapeutics are driving market growth.

FAQs

What is brimonidine tartrate used for?

Brimonidine tartrate is used to relieve ocular redness due to minor eye irritations, reduce intraocular pressure in glaucoma patients, and is being studied for its use in presbyopia.

What are the common adverse events associated with brimonidine tartrate?

Common adverse events include ocular hyperemia and eye irritation, with serious adverse events being infrequent.

Which companies are major players in the brimonidine tartrate market?

Major players include Bausch & Lomb, Upsher-Smith Laboratories, and Visus Therapeutics.

What is the projected market growth for brimonidine tartrate?

The global market is expected to grow significantly, with a notable CAGR during the 2018-2023 period.

Are there any ongoing clinical trials for brimonidine tartrate?

Yes, Visus Therapeutics is conducting a phase 3 trial for BRIMOCHOL™ PF, a fixed-dose combination of carbachol and brimonidine tartrate for presbyopia.

Sources

1. FDA: Cross Discipline Team Leader Review for Brimonidine Tartrate Ophthalmic Solution 0.025%[1].
2. Maiaresearch: Global Brimonidine Tartrate Industry Market Research Report[2].
3. ClinicalTrials.gov: Clinical Study Protocol for BRIMOCHOL™ PF[3].
4. FDA: Clinical Review for Brimonidine Tartrate Ophthalmic Solution 0.025% (Lumify™)[4].
5. Upsher-Smith: Press Release on the Launch of Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution[5].