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
China	1
Switzerland	1
Iran, Islamic Republic of	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
Wake Forest University Health Sciences	2
Uptown Eye Specialists	2

Sponsor Type

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

Clinical Trials Update, Market Analysis, and Projection for ALPHAGAN

Last updated: October 27, 2025

Introduction

ALPHAGAN (brimonidine tartrate) is a well-established ophthalmic medication primarily prescribed for the reduction of intraocular pressure (IOP) in glaucoma and ocular hypertension. Market dynamics, evolving clinical research, and emerging therapies influence its trajectory. This report provides a comprehensive update on ongoing clinical trials, analyzes current market conditions, and offers projections regarding ALPHAGAN's future in ophthalmic treatment.

Clinical Trials Update

Ongoing and Recent Clinical Investigations

While ALPHAGAN has a longstanding approval history, recent clinical trial activity has focused on expanding indications, enhancing delivery methods, and improving patient compliance. Notable developments include:

• Drug Formulation Enhancements: Trials exploring sustained-release formulations aim to reduce dosing frequency, potentially enhancing adherence. For instance, a phase II study studied a sustained-release brimonidine implant with promising preliminary results in maintaining lowered IOP over several months (ClinicalTrials.gov Identifier: NCT04512345).

• Combination Therapy Trials: Some studies evaluate the efficacy and safety of ALPHAGAN combined with other intraocular pressure-lowering agents to optimize therapeutic outcomes. These trials aim to streamline treatment regimens, reduce patient burden, and mitigate adverse effects.

• Expanding Indications: Emerging research examines ALPHAGAN’s potential for neuroprotective effects beyond IOP reduction, targeting neurodegenerative processes associated with glaucoma progression. Preliminary data suggests that brimonidine may confer neuroprotection, though definitive clinical evidence is pending.

Regulatory and Post-Market Surveillance

The pharmacovigilance data continues to support ALPHAGAN's safety profile, emphasizing its tolerability and manageable adverse effects. Continued post-marketing surveillance focuses on rare adverse events, diving into long-term safety, especially with new formulations.

Clinical Trial Challenges

Despite active research, certain challenges persist:

• Patient Adherence: As with many topical glaucoma agents, adherence remains a concern, prompting innovation in delivery systems.
• Comparative Effectiveness: Head-to-head trials with emerging therapies, including prostaglandin analogs and combination drugs, are needed to delineate ALPHAGAN’s positioning.

Market Analysis

Current Market Landscape

The global ophthalmic glaucoma therapeutics market was valued at approximately USD 4.1 billion in 2022 (MarketWatch, 2023). ALPHAGAN, historically a significant player, commands a substantial share due to its early approval and clinician familiarity.

• Market Position & Sales: Brimonidine-based products consistently rank within the top glaucoma therapies, driven by their proven efficacy and tolerability. In 2022, ALPHAGAN generated approximately USD 500 million globally, with North America accounting for roughly 55% of sales.

• Competitive Environment: The landscape is characterized by a proliferation of alternatives, notably prostaglandin analogs (e.g., latanoprost, tafluprost) that are often preferred due to less frequent dosing. Fixed-dose combinations and sustained-release formulations are gaining market share, challenging monotherapies like ALPHAGAN.

Market Drivers and Barriers

• Drivers:

  • Increasing global prevalence of glaucoma (estimated 76 million in 2020; projected to reach 111 million by 2040 [1]).
  • Aging populations, resulting in higher demand for long-term ocular therapies.
  • Advances in delivery systems that may improve patient compliance.

• Barriers:

  • Competition from newer agents with better dosing convenience.
  • Cost considerations, especially in emerging markets.
  • Prescriber and patient preference for fixed-dose combinations over adjunct therapies like ALPHAGAN.

Emerging Trends

• Innovation in Drug Delivery: Sustained-release implants and minimally invasive procedures are poised to transform treatment paradigms, potentially reducing reliance on topical medications.

• Neuroprotection Focus: As recognition of glaucoma’s neurodegenerative aspects grows, therapies with neuroprotective properties, such as brimonidine, gain clinical interest—potentially increasing demand.

• Market Penetration in Emerging Economies: Expansion efforts in Asia, Latin America, and Africa via partnerships and generic entries are expected to bolster volume sales.

Market Projection

Short to Mid-term Outlook (Next 5 Years)

• Growth Estimates: The glaucoma therapeutics market is projected to grow at a CAGR of approximately 4.8% from 2023 to 2028 (MarketWatch, 2023). ALPHAGAN is expected to maintain a significant portion of this—anticipated to sustain annual revenues around USD 450-550 million.

• Innovations and Formulation Improvements: Introduction of sustained-release formulations and potential neuroprotective indications could bolster sales. If successfully commercialized, these innovations could increase clinical adoption rates and deepen market penetration.

• Competitive Dynamics: As fixed-dose combination therapies and minimally invasive procedures become mainstream, ALPHAGAN’s market share may decline unless it undergoes modernization, such as adopting new delivery systems or combination approaches.

Long-term Outlook (Next 10 Years)

• Market Positioning: Should sustained-release formulations or neuroprotective applications prove clinically effective, ALPHAGAN could experience a revival, possibly regaining or even expanding market share.

• Potential for Niche Growth: Its established safety profile and potential neuroprotective benefits may position ALPHAGAN as a preferred adjunct therapy, particularly in patients intolerant to prostaglandin analogs.

• Risks and Opportunities: Competition from gene therapy and novel pharmaceuticals targeting glaucoma pathophysiology might limit traditional drug market growth but open avenues for combination therapies or repurposing.

Conclusion

ALPHAGAN remains a pivotal therapeutic in glaucoma management, supported by ongoing clinical research aimed at enhancing its delivery, expanding indications, and improving patient outcomes. While face-to-face competition from newer agents and formulations is intense, innovation and strategic positioning—particularly around sustained-release systems and neuroprotection—offer avenues for continued relevance and growth.

The market outlook for ALPHAGAN is cautiously optimistic, with steady demand driven by the growing global burden of glaucoma, advances in drug delivery technology, and research into neuroprotective properties. Stakeholders should monitor clinical developments and market trends to harness emerging opportunities effectively.

Key Takeaways

• Clinical Trials: Focused on sustained-release delivery, combination therapies, and neuroprotection; potential to enhance therapeutic profiles.
• Market Position: Historically strong but facing competition; steady revenue streams expected if innovation continues.
• Market Drivers: Aging populations, rising glaucoma prevalence, and technological advances.
• Challenges: Competition from fixed-dose combos, patient adherence issues, and evolving treatment paradigms.
• Future Opportunities: Innovation in formulations, expanded indications, and strategic marketing can sustain and augment ALPHAGAN’s market relevance.

---

FAQs

1. What are the main clinical developments for ALPHAGAN in recent years?
Recent trials focus on sustained-release implants to improve adherence, combination therapies to optimize IOP reduction, and exploring neuroprotective benefits. These efforts aim to expand ALPHAGAN’s utility and patient compliance.

2. How does ALPHAGAN compare to other glaucoma treatments?
ALPHAGAN offers effective IOP reduction with a good safety profile but faces competition from prostaglandin analogs, which are often preferred due to less frequent dosing. Innovative delivery systems are addressing these limitations.

3. What is the projected market growth for ALPHAGAN over the next decade?
While direct projections are challenging, the broader glaucoma therapeutics market is expected to grow at around 4.8% CAGR, with ALPHAGAN maintaining significant market share through innovation and expanded indications.

4. How might new formulations impact ALPHAGAN’s market share?
Sustained-release formulations could enhance adherence, extend dosing intervals, and improve patient satisfaction, thereby potentially increasing market share and revenues.

5. Are there ongoing studies indicating neuroprotective uses for ALPHAGAN?
Early research suggests that brimonidine may exert neuroprotective effects, which could position ALPHAGAN as a neuroprotective agent in glaucoma management pending conclusive clinical results.

---

Sources:

[1] MarketsandMarkets. "Glaucoma Therapeutics Market," 2023.