CLINICAL TRIALS PROFILE FOR ALPHAGAN

505(b)(2) Clinical Trials for Alphagan

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
OTC	NCT00402493 ↗	Study to Determine if Taking OTC Non-Steroidal Anti-Inflammatory Affects Eye Pressure in Patients Using Glaucoma Drops	Completed	Pfizer	N/A	2006-12-01	The Purpose of This Study is to Determine if Taking an Over the Counter Non-Steroidal Anti-Inflammatory(Ibuprofen)has an Effect on Eye Pressure in Patients using Brimonidine(Alphagan)and Latanoprost(Xalatan) eye drops.
OTC	NCT00402493 ↗	Study to Determine if Taking OTC Non-Steroidal Anti-Inflammatory Affects Eye Pressure in Patients Using Glaucoma Drops	Completed	Philadelphia Eye Associates	N/A	2006-12-01	The Purpose of This Study is to Determine if Taking an Over the Counter Non-Steroidal Anti-Inflammatory(Ibuprofen)has an Effect on Eye Pressure in Patients using Brimonidine(Alphagan)and Latanoprost(Xalatan) eye drops.

All Clinical Trials for Alphagan

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
NCT00348400 ↗	Brimonidine Purite 0.15% Versus Dorzolamide 2% Used as Adjunctive Therapy to Latanoprost	Completed	Innovative Medical	Phase 4	1969-12-31	Evaluate the relative efficacy and tolerability of Alphagan P compared to Trusopt as adjunctive therapy
NCT00402493 ↗	Study to Determine if Taking OTC Non-Steroidal Anti-Inflammatory Affects Eye Pressure in Patients Using Glaucoma Drops	Completed	Pfizer	N/A	2006-12-01	The Purpose of This Study is to Determine if Taking an Over the Counter Non-Steroidal Anti-Inflammatory(Ibuprofen)has an Effect on Eye Pressure in Patients using Brimonidine(Alphagan)and Latanoprost(Xalatan) eye drops.
NCT00402493 ↗	Study to Determine if Taking OTC Non-Steroidal Anti-Inflammatory Affects Eye Pressure in Patients Using Glaucoma Drops	Completed	Philadelphia Eye Associates	N/A	2006-12-01	The Purpose of This Study is to Determine if Taking an Over the Counter Non-Steroidal Anti-Inflammatory(Ibuprofen)has an Effect on Eye Pressure in Patients using Brimonidine(Alphagan)and Latanoprost(Xalatan) eye drops.
NCT00413751 ↗	Effect of Brimonidine Tartrate Ophthalmic Solution 0.15% on Pupil Diameter in Normal Eyes	Completed	Walter Reed Army Medical Center		1969-12-31	The objective of this study is to evaluate the effect of brimonidine tartrate ophthalmic solution 0.15% (Alphagan P) on pupil diameter under different luminance conditions.
NCT00440336 ↗	Comparison of Efficacy of Two Groups of Glaucoma Drops (Xalatan vs.Cosopt) in Reducing Eye Pressure Following Laser (SLT)Treatment in the Management of Glaucoma.	Unknown status	Merck Sharp & Dohme Corp.	N/A	2006-10-01	WHAT IS THIS STUDY ABOUT? Glaucoma and ocular hypertension are chronic eye diseases that can damage the optic nerve and lead to vision loss or blindness. The optic nerve acts like an electric cable with over a million wires. This nerve is responsible for carrying images from the eye to the brain. The way glaucoma and ocular hypertension cause blindness depends on many factors, but the most important factor is the increased pressure inside the eye (intraocular pressure). There is no cure for glaucoma or ocular hypertension. However, lowering the pressure inside the eye has been shown to slow the progression of disease. Intraocular pressure can be lowered by glaucoma medication, laser treatment, or surgery. You have open angle glaucoma, pseudoexfoliative glaucoma, or ocular hypertension. Researchers want to find out more about how 2 drugs called Cosopt (dorzolamide hydrochloride and timolol maleate) and Xalatan (latanoprost) can help people with these conditions. Cosopt and Xalatan are both eye drops that are approved by the U.S. Food and Drug Administration (FDA) to reduce intraocular pressure in people with open angle glaucoma and ocular hypertension. The study doctor will do a laser procedure called Selective Laser Trabeculoplasty (SLT) on people in this study to help lower their intraocular pressure. The FDA has approved SLT to treat open angle glaucoma and ocular hypertension. Then the study doctor will ask some participants to use either Cosopt or Xalatan, if their intraocular pressure is still too high 4 to 6 weeks after the SLT procedure. The study doctor wants to see which of the 2 study drugs (Cosopt or Xalatan) is better at reducing intraocular pressure after SLT. It is planned that about 30 people with glaucoma or ocular hypertension who are at least 18 years old will be in this study. Out of the participants whose intraocular pressure is still too high after SLT, half will use Cosopt and half will use Xalatan. You do not have to be in this study to have SLT or to use Cosopt or Xalatan.

Clinical Trial Conditions for Alphagan

Condition Name

Condition Name for Alphagan
Intervention	Trials
Glaucoma	8
Ocular Hypertension	7
Open Angle Glaucoma	3
Healthy	2

Condition MeSH

Condition MeSH for Alphagan
Intervention	Trials
Glaucoma	13
Ocular Hypertension	8
Hypertension	7
Glaucoma, Open-Angle	5

Clinical Trial Locations for Alphagan

Trials by Country

Trials by Country for Alphagan
Location	Trials
United States	44
Israel	3
Brazil	1
Canada	1
China	1

Trials by US State

Trials by US State for Alphagan
Location	Trials
Pennsylvania	4
California	4
North Carolina	3
Massachusetts	3
Florida	3

Clinical Trial Progress for Alphagan

Clinical Trial Phase

Clinical Trial Phase for Alphagan
Clinical Trial Phase	Trials
Phase 4	6
Phase 3	1
Phase 2	4

Clinical Trial Status

Clinical Trial Status for Alphagan
Clinical Trial Phase	Trials
Completed	18
Unknown status	3
Recruiting	2

Clinical Trial Sponsors for Alphagan

Sponsor Name

Sponsor Name for Alphagan
Sponsor	Trials
Allergan	3
Uptown Eye Specialists	2
Wake Forest University Health Sciences	2

Sponsor Type

Sponsor Type for Alphagan
Sponsor	Trials
Other	22
Industry	9
U.S. Fed	1

Alphagan Market Analysis and Financial Projection

Last updated: April 26, 2026

ALPHAGAN (brimonidine tartrate ophthalmic): Clinical-trial status, market analysis, and projection

What is ALPHAGAN and what does its clinical program look like?

ALPHAGAN is an ophthalmic formulation of brimonidine tartrate (alpha-2 adrenergic agonist), used for reducing intraocular pressure (IOP) in glaucoma and ocular hypertension. Current commercial product offerings in the US and major markets include ALPHAGAN (brimonidine 0.2% solution) and ALPHAGAN P (brimonidine 0.15% solution).

Clinical trials: update view

Across major registries, ALPHAGAN-brimonidine programs show a pattern typical of mature products:

• Ongoing studies skew toward comparative efficacy, formulation, dosing, and real-world endpoints, rather than new molecular entity trials.
• Head-to-head and regimen-optimization studies remain the most common category in late-stage pipelines for established glaucoma agents.

A complete “trial-by-trial” status update (phase, start/completion dates, enrollment, sites, results) is not possible from the information in this prompt alone. The registries that would be used for a rigorous update are ClinicalTrials.gov and (depending on geography) the WHO ICTRP and local regulators, but no trial identifiers or study links are provided here.

What is the market for brimonidine/ALPHAGAN and how is it trending?

The glaucoma market is large and growing, driven by aging populations, expanded diagnosis, and ongoing treatment intensity. Brimonidine competes in a crowded field:

• Prostaglandin analogs (first-line in many guidelines)
• Beta-blockers
• Carbonic anhydrase inhibitors
• Rho kinase inhibitors
• Combination products that consolidate IOP-lowering mechanisms

In US claims and prescription patterns, brimonidine has historically held a role as a cost-effective option and as a second-line add-on in combination regimens, particularly when prostaglandin monotherapy is insufficient or not tolerated.

Pricing and reimbursement dynamics that affect ALPHAGAN

Key market drivers affecting ALPHAGAN-like assets typically include:

• Generic and competitive pricing pressure for brimonidine tartrate solutions
• Formulation preference between different brimonidine strengths and dosing schedules
• PBM placement and prior authorization driven by IOP-lowering guideline pathways
• Switching behavior after tolerability events (ocular hyperemia, burning, dryness), which is a known class issue for alpha-agonists

Market projection: what matters for ALPHAGAN

For established glaucoma drugs facing generic competition, the projection is usually determined by three variables:

1. Net price erosion from generics and trade-down
2. Share retention via formulary access and patient persistence
3. Incremental growth from overall glaucoma market expansion

With brimonidine tartrate already an established active ingredient, growth is generally modest and tied more to market share stability than to major clinical differentiation.

Because the prompt provides no geographic scope, no historical revenue baseline, and no competitor share or pricing inputs, producing a quantified forecast (CAGR, revenue range by year, market share deltas) would require data that is not included in the request.

What is the regulatory and product landscape impacting near-term sales?

ALPHAGAN and related brimonidine ophthalmics are regulated as ophthalmic drug products with labeling constraints tied to:

• Indications (IOP reduction in glaucoma or ocular hypertension)
• Dosing schedule
• Contraindications and warnings (class effects)
• Pediatric labeling where applicable
• Bioequivalence expectations for generics

For a mature molecule, regulatory risk is generally lower than for new chemical entities, but commercial risk remains high from competitive entry and formulary changes.

Competitive position: where ALPHAGAN sits in therapy

In treatment algorithms, brimonidine is commonly used as:

• Monotherapy when first-line agents are not suitable
• Add-on therapy to prostaglandin analogs or other IOP reducers
• Substitution when a patient experiences intolerance to other classes

Its utilization depends on:

• Formulary tier placement
• Dosing convenience and tolerability
• Patient persistence relative to prostaglandin-based regimens

Key references for ALPHAGAN clinical and regulatory grounding

• The drug and indication are described in the FDA labeling for brimonidine ophthalmic products (ALPHAGAN and ALPHAGAN P), including usage for IOP reduction in glaucoma and ocular hypertension.
• Mechanism and clinical context are standard for alpha-2 adrenergic agonists used in glaucoma therapy.

Key Takeaways

• ALPHAGAN is a mature brimonidine tartrate ophthalmic product used for IOP reduction in glaucoma and ocular hypertension.
• Clinical-trial activity is typically comparative and optimization-oriented for established brimonidine products, rather than first-in-class late-stage innovation.
• Market outcomes for ALPHAGAN are driven by generic and competitive pricing, formulary access, and persistence/tolerability in chronic glaucoma care.
• A quantified year-by-year financial projection cannot be produced from the prompt data provided here.

FAQs

1. Is ALPHAGAN still actively studied in clinical trials?
   Alpha-agonist brimonidine studies continue in registries, but mature-product trial activity tends to emphasize comparative efficacy, regimen evaluation, and endpoints relevant to clinical practice.

2. What competitors most pressure ALPHAGAN in glaucoma treatment?
   Prostaglandin analogs, combination products, beta-blockers, and other IOP-lowering classes, with competitive pressure amplified by generic availability.

3. What is ALPHAGAN’s primary clinical use?
   Reduction of intraocular pressure in glaucoma and ocular hypertension.

4. What typically impacts ALPHAGAN utilization the most?
   Formulary placement, pricing versus generics, and persistence driven by ocular tolerability.

5. What drives the outlook for brimonidine ophthalmics?
   Net price trends, share stability in formulary categories, and overall glaucoma patient growth.

References

[1] U.S. Food and Drug Administration. ALPHAGAN (brimonidine tartrate ophthalmic solution) prescribing information. FDA label.
[2] U.S. Food and Drug Administration. ALPHAGAN P (brimonidine tartrate ophthalmic solution) prescribing information. FDA label.
[3] ClinicalTrials.gov. Brimonidine clinical studies (registry entries). National Library of Medicine.