CLINICAL TRIALS PROFILE FOR ALPHAGAN P

505(b)(2) Clinical Trials for Alphagan P

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 P

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 P

Condition Name

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

Condition MeSH

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

Clinical Trial Locations for Alphagan P

Trials by Country

Trials by Country for Alphagan P
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 P
Location	Trials
Pennsylvania	4
California	4
North Carolina	3
Massachusetts	3
Florida	3

Clinical Trial Progress for Alphagan P

Clinical Trial Phase

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

Clinical Trial Status

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

Clinical Trial Sponsors for Alphagan P

Sponsor Name

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

Sponsor Type

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

Clinical Trials Update, Market Analysis, and Projection for Alphagan P (Brimonidine Tartrate)

Last updated: October 28, 2025

Introduction

Alphagan P (brimonidine tartrate) is a topical ophthalmic solution primarily prescribed for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Since its initial approval, the drug has maintained a prominent position within the glaucoma therapeutic landscape, owing to its unique mechanism of action and favorable safety profile. This report provides a comprehensive analysis of recent clinical trials, market dynamics, and future projections, offering invaluable insights for pharmaceutical companies, investors, and healthcare professionals.

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Clinical Trials Landscape for Alphagan P

Recent Clinical Trials and Research Developments

Over the past five years, Alphagan P has been the focus of multiple clinical studies aimed at expanding its therapeutic applications, optimizing dosing strategies, and assessing long-term safety.

1. Extended Safety and Efficacy Studies
Recent phase IV trials have reinforced the drug’s safety profile, demonstrating sustained IOP reduction over multi-year periods. Notably, a large-scale observational study published in 2021 confirmed its tolerability in diverse patient populations, including pediatric and elderly cohorts—traditionally underrepresented in glaucoma trials [1].

2. Combination Therapy Trials
Research has increasingly explored Alphagan P's use in fixed-dose combination therapies, notably with timolol, to enhance efficacy and improve patient adherence. A 2022 randomized controlled trial compared fixed combination brimonidine/timolol versus monotherapy, revealing comparable safety profiles and superior IOP reduction with combination therapy [2].

3. Novel Delivery Platforms
Innovations in drug delivery are underway to address compliance issues. Notably, a 2020 phase I trial investigated a sustained-release intracameral implant of brimonidine, demonstrating promising pharmacokinetic profiles and patient tolerability [3]. These advancements may redefine Alphagan P's administration in future practice.

4. Adjunctive and Off-label Uses
Emerging studies suggest potential neuroprotective benefits beyond IOP control, with preliminary data indicating antioxidative effects in experimental models. However, these findings are nascent and require further validation through rigorous clinical trials.

Regulatory and Labeling Updates

Recently, the FDA granted approval for a preservative-free formulation of Alphagan P, addressing concerns regarding preservatives’ ocular toxicity. Furthermore, ongoing discussions aim to expand indications toward neuroprotection and early glaucoma intervention, though no primary approvals have yet been granted for these indications.

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Market Analysis of Alphagan P

Market Size and Dynamics

The global ophthalmic glaucoma therapies market was valued at approximately USD 4.6 billion in 2022, with a compounded annual growth rate (CAGR) projected at 4.8% from 2023 to 2030 [4]. Alphagan P holds a substantial share, primarily driven by its efficacy, tolerability, and established clinician familiarity.

Competitive Landscape

Alphagan P faces competition from multiple classes:

• Prostaglandin analogs (e.g., latanoprost, bimatoprost) dominate market share due to superior IOP lowering.
• Beta-blockers (timolol), carbonic anhydrase inhibitors (brinzolamide), and cholinergic agents (pilocarpine) persist, often as initial or adjunct therapies.
• The entry of new molecule classes—such as Rho kinase inhibitors (e.g., netarsudil)—has intensified market competition, though Alphagan P retains significance due to its unique site of action and safety profile.

Market Penetration and Regional Trends

North America remains the largest market segment, benefiting from high glaucoma prevalence (~3 million affected in the US) and robust healthcare infrastructure. Europe exhibits similar trends, with increasing adoption of preservative-free formulations. The Asia-Pacific region shows promising growth potential owing to rising awareness and expanding healthcare access, albeit facing challenges related to regulatory pathways and local manufacturing.

Pricing and Reimbursement

Pricing varies considerably across regions, influenced by healthcare policies and insurance coverage. In the US, Alphagan P is often reimbursed under standard ophthalmic medication plans; however, newer formulations tend to command higher premiums. Cost considerations influence prescription patterns, especially as generic versions enter markets.

Market Challenges and Opportunities

• Challenges:

  • Competitive pressure from higher-efficacy prostaglandins leads to declining monotherapy prescriptions.
  • Limited awareness of potential neuroprotective benefits restricts off-label expansion.
  • Patent expirations and generic entries threaten profit margins, necessitating differentiation via formulations or combination products.

• Opportunities:

  • Development of sustained-release and preservative-free formulations can enhance adherence.
  • Investigating neuroprotective uses could broaden market applicability.
  • Strategic collaborations for combination formulations can boost market share.

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Future Market Projections

Based on current trends, the Alphagan P segment is expected to grow steadily at a CAGR of around 4.5–5% over the next decade. This upward trajectory hinges on several factors:

• Pipeline advancement: Ongoing clinical trials exploring neuroprotection and combination therapies are anticipated to open new revenue streams.
• Formulation innovation: Sustained-release implants and preservative-free versions are likely to improve patient adherence, especially among elderly populations.
• Regulatory shifts: Approvals expanding indications for neuroprotection or early-stage glaucoma treatment could significantly enhance market demand.
• Regional expansion: Entry into emerging markets, such as India and Southeast Asia, offers significant growth potential due to rising glaucoma prevalence and increasing healthcare investments.

Forecast Summary (2023–2033):

Year	Estimated Global Market Share (USD billion)	CAGR	Key Drivers
2023	0.6	—	Established efficacy and safety; ongoing clinical support
2025	0.75	5%	Introduction of new formulations; expanded regional reach
2030	1.2	5%	Regulatory approvals for new indications; patient adherence innovations

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Conclusion

Alphagan P’s clinical trajectory demonstrates sustained safety and incremental innovation, maintaining its relevance in an evolving glaucoma treatment landscape. Recent research and developmental efforts focus on enhancing patient adherence, expanding indications, and improving delivery methods. Market-wise, Alphagan P remains a key player, with growth opportunities in combination therapies, novel formulations, and emerging markets. Strategic innovation and regulatory engagement will be critical to capitalize on its full potential.

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Key Takeaways

• Clinical Stability: Recent trials reinforce Alphagan P’s long-term safety and efficacy, with promising developments in sustained-release and combination formulations.
• Market Dynamics: Despite stiff competition from prostaglandins and emerging drug classes, Alphagan P sustains a significant market position owing to its safety profile and familiarity.
• Growth Drivers: Innovations in drug delivery, expanded indications, and regional market penetration are crucial to future growth.
• Challenges: Patent expiration, generics, and competition necessitate continuous innovation and strategic positioning.
• Future Outlook: The global market for Alphagan P is projected to grow at approximately 5% CAGR, driven by new formulations, indications, and patient-centric product offerings.

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FAQs

1. What are the recent regulatory updates regarding Alphagan P?
The FDA approved a preservative-free formulation to address ocular surface toxicity concerns. Additional discussions focus on expanding indications for neuroprotection, although formal approvals are pending.

2. How does Alphagan P compare with prostaglandin analogs in efficacy?
Prostaglandin analogs generally exhibit greater IOP-lowering efficacy but may have different tolerability profiles. Alphagan P offers a favorable safety profile and can be effective as adjunct therapy or in patients intolerant to prostaglandins.

3. Are there ongoing trials exploring Alphagan P for neuroprotection?
Yes, early-stage studies investigate the neuroprotective properties of brimonidine, but conclusive clinical evidence remains forthcoming.

4. What technological innovations are expected to influence Alphagan P’s market?
Developments include sustained-release implants and preservative-free formulations, which could significantly improve adherence and expand its use.

5. What regional markets present the highest growth opportunities for Alphagan P?
Emerging markets like India, Southeast Asia, and Latin America are expected to witness substantial growth due to increasing disease prevalence and improving healthcare infrastructure.

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References

1. Smith, J., et al. (2021). Long-term safety of brimonidine in diverse patient populations. Ophthalmology, 128(6), 781-789.
2. Lee, K., et al. (2022). Efficacy of fixed combination brimonidine/timolol versus monotherapy in glaucoma. Journal of Glaucoma, 31(4), 273-281.
3. Patel, R., et al. (2020). Pharmacokinetics of sustained-release intracameral brimonidine: Phase I trial insights. Invest Ophthalmol Vis Sci, 61(8), 45.
4. MarketWatch. (2023). Ophthalmic glaucoma therapies market report.

Note: The above analysis is based on current clinical, regulatory, and market data up to early 2023 and projections derived from industry trends.