CLINICAL TRIALS PROFILE FOR BROMFENAC SODIUM

All Clinical Trials for Bromfenac Sodium

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00198445 ↗	Safety and Efficacy Study of Topical Bromfenac Versus Placebo to Treat Ocular Inflammation After Cataract Surgery	Completed	Bausch & Lomb Incorporated	Phase 3	2003-05-01	The primary objective of this study was to investigate the efficacy of bromfenac sodium ophthalmic solution 0.09% for treatment of post-operative ocular inflammation in subjects who undergo cataract extraction and intraocular lens implantation. The secondary objective was to investigate the safety and tolerability of the same.
NCT00595543 ↗	Treatment of Acute Pseudophakic Cystoid Macular Edema: Bromfenac 0.09% Versus Diclofenac Sodium 0.1% Versus Ketorolac Tromethamine 0.5%	Completed	Bp Consulting, Inc	Phase 4	2008-01-01	To compare bromfenac 0.09%, diclofenac sodium 0.1%, and ketorolac tromethamine 0.5% ophthalmic solutions for the treatment of acute pseudophakic CME after cataract surgery.
NCT01387464 ↗	Aqueous Humor Concentration of InSite Vision (ISV) 303 (Bromfenac in DuraSite) to Bromday Once Daily (QD) Prior to Cataract Surgery	Completed	InSite Vision	Phase 2	2011-07-01	The purpose of this study is to evaluate the aqueous humor concentration of bromfenac sodium in subjects administered multiple topical ocular doses of ISV-303 or Bromday™ QD prior to routine cataract surgery.
NCT01387464 ↗	Aqueous Humor Concentration of InSite Vision (ISV) 303 (Bromfenac in DuraSite) to Bromday Once Daily (QD) Prior to Cataract Surgery	Completed	Sun Pharma Global FZE	Phase 2	2011-07-01	The purpose of this study is to evaluate the aqueous humor concentration of bromfenac sodium in subjects administered multiple topical ocular doses of ISV-303 or Bromday™ QD prior to routine cataract surgery.
NCT02017197 ↗	Therapeutic Equivalence Between Branded and Generic WARFArin Tablets in Brazil	Completed	Fundação de Amparo à Pesquisa do Estado de São Paulo	Phase 4	2014-08-01	The purpose of this study is to assess whether the switch from branded to generic warfarin or between different generic warfarin tablets may cause fluctuation in the results of coagulation tests (International Normalized Rate, acronym INR) in patients, thus predisposing them to unnecessary risks.
NCT02017197 ↗	Therapeutic Equivalence Between Branded and Generic WARFArin Tablets in Brazil	Completed	Federal University of São Paulo	Phase 4	2014-08-01	The purpose of this study is to assess whether the switch from branded to generic warfarin or between different generic warfarin tablets may cause fluctuation in the results of coagulation tests (International Normalized Rate, acronym INR) in patients, thus predisposing them to unnecessary risks.
NCT02681679 ↗	Topical 0.1% Bromfenac Sodium and Prostaglandin E2 Inhibition in Cataract Surgery	Completed	Ministry of Health, China	N/A	2014-10-01	Since a new generation of femtosecond lasers became available for cataract surgery in 2009, the use of this image-guided system has provided several benefits, including a reduction in phacoemulsification energy by prefragmentation of the crystalline lens, and the potential advantages of more precise corneal incisions and capsulotomy formation. However, as with any new surgical technique, femtosecond laser cataract surgery also has potential complications. Intraoperative miosis is one of the most common intraoperative complications of femtosecond laser-assisted cataract surgery, with a reported prevalence ranging from 9.5 to 32.0%.8 Significant pupillary constriction necessitates the removal of the anterior capsule flap, fragmented nucleus and remaining cortex, which is potentially associated with a higher rate of surgery-related complications.

Clinical Trial Conditions for Bromfenac Sodium

Condition Name

Condition Name for Bromfenac Sodium
Intervention	Trials
Cataract	3
Acute Pseudophakic Cystoid Macular Edema	1
Atrial Fibrillation	1
Familial Exudative Vitreoretinopathies	1

Condition MeSH

Condition MeSH for Bromfenac Sodium
Intervention	Trials
Cataract	3
Retinal Diseases	1
Familial Exudative Vitreoretinopathies	1
Atrial Fibrillation	1

Clinical Trial Locations for Bromfenac Sodium

Trials by Country

Trials by Country for Bromfenac Sodium
Location	Trials
United States	25
China	1
Brazil	1

Trials by US State

Trials by US State for Bromfenac Sodium
Location	Trials
Pennsylvania	2
Colorado	1
California	1
Arkansas	1
Alabama	1

Clinical Trial Progress for Bromfenac Sodium

Clinical Trial Phase

Clinical Trial Phase for Bromfenac Sodium
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	1
Phase 2	2

Clinical Trial Status

Clinical Trial Status for Bromfenac Sodium
Clinical Trial Phase	Trials
Completed	5
Not yet recruiting	1

Clinical Trial Sponsors for Bromfenac Sodium

Sponsor Name

Sponsor Name for Bromfenac Sodium
Sponsor	Trials
Bausch & Lomb Incorporated	1
Bp Consulting, Inc	1
InSite Vision	1

Sponsor Type

Sponsor Type for Bromfenac Sodium
Sponsor	Trials
Other	6
Industry	3

Bromfenac Sodium: Clinical Trials, Market Analysis, and Projections

Introduction to Bromfenac Sodium

Bromfenac sodium is a nonsteroidal anti-inflammatory drug (NSAID) widely used in ophthalmic solutions for the treatment of postoperative inflammation and pain, particularly following cataract surgery. It works by inhibiting the cyclooxygenase II (COX-II) enzyme, thereby reducing the production of prostaglandins, which are key mediators of inflammation and pain.

Clinical Trials and Efficacy

Key Findings from Clinical Trials

Several clinical trials have demonstrated the efficacy and safety of bromfenac sodium in treating postoperative inflammation and pain.

• Two randomized, masked vehicle-controlled clinical trials showed that bromfenac ophthalmic solution 0.07% was superior to the vehicle in reducing ocular inflammation and pain. These trials indicated significant differences in the proportion of subjects with cleared ocular inflammation and those who were pain-free at various study visits[1].
• The trials also highlighted that more patients in the bromfenac arm completed the treatment without needing rescue therapy, and fewer adverse reactions were reported compared to the vehicle arm[1].

Meta-Analyses and Systematic Reviews

A systematic review and meta-analysis of randomized controlled trials (RCTs) on the use of sodium bromfenac eye drops for postoperative inflammation after cataract surgery confirmed the drug's efficacy. The review, which included data from multiple databases, showed a reliable clinical effect of sodium bromfenac in reducing inflammation, although the evidence from RCTs was not entirely consistent[4].

Safety Profile

The safety of bromfenac sodium has been evaluated in numerous studies. For instance, a study involving 222 patients treated with bromfenac 0.07% and 218 patients receiving a vehicle showed that the drug was well-tolerated, with fewer adverse reactions compared to the vehicle group. Common adverse reactions included anterior chamber inflammation and eye pain, which could also indicate a lack of efficacy in some cases[1].

Market Analysis

Global Market Trends

The global bromfenac sodium market is experiencing significant growth driven by several factors:

• Increasing Prevalence of Ocular Diseases: The rising incidence of ocular conditions such as cataracts and glaucoma is driving the demand for effective anti-inflammatory drugs like bromfenac sodium[2][5].
• Advanced Healthcare Infrastructure: Regions like North America, particularly the United States, and Europe, especially Germany and the UK, are leading the market due to their advanced healthcare infrastructure and high patient awareness[2][5].
• Regulatory Support: The FDA’s approval of various bromfenac formulations and the European Medicines Agency’s streamlined approval process have bolstered the market[2].

Regional Insights

• North America: This region is a significant market for bromfenac sodium, driven by advanced healthcare infrastructure and high patient awareness. The FDA’s approvals have expanded the drug’s applications in treating postoperative inflammation and pain following cataract surgery[2].
• Europe: Countries like Germany and the UK are key players due to their aging population and robust healthcare policies. The EMA’s support has fostered innovation and market entry for new ophthalmic solutions[2].
• Asia-Pacific: Emerging markets in this region, such as India and China, are witnessing rapid growth as healthcare infrastructure improves and access to ophthalmic care expands. The rising middle class in these countries is driving demand for bromfenac sodium[2][5].
• Middle East and Africa: These regions are expected to expand as healthcare infrastructure improves and awareness of eye health increases. Countries like South Africa and the UAE are investing in advanced medical technologies, positioning themselves as potential growth areas[2].

Competitive Landscape

The global bromfenac sodium market is characterized by a dynamic competitive landscape. Market leaders are leveraging advanced manufacturing technologies, such as nanotechnology, to enhance bioavailability and the onset of action. Strategic partnerships and the integration of digital health solutions, like telemedicine, are also strengthening their market positions[2].

Market Projections

Growth Forecast

The bromfenac sodium market is projected to grow at a compound annual growth rate (CAGR) of around 6% over the next several years. This growth is driven by the increasing prevalence of ocular diseases, advancements in surgical techniques, and the growing adoption of minimally invasive procedures[2][5].

Market Size and Segmentation

• Market Size: The global bromfenac sodium market is expected to reach significant values by 2031, with historical data indicating steady growth from 2021 to 2022[5].
• Segmentation: The market is segmented by type (original drug and generic drug) and distribution channel (hospital pharmacies, retail pharmacies, and online pharmacies). This segmentation helps in understanding the different dynamics driving the market[5].

Future Trends

• Innovative Formulations: The introduction of innovative formulations, such as preservative-free bromfenac eye drops, is enhancing patient compliance and expanding market reach. These formulations have shown promising results in reducing ocular discomfort and improving patient satisfaction[2].
• Government Initiatives: Government initiatives aimed at improving healthcare access and affordability are expected to further bolster market growth, especially in emerging markets[2].

Key Takeaways

• Clinical Efficacy: Bromfenac sodium has demonstrated significant efficacy in reducing postoperative inflammation and pain following cataract surgery.
• Market Growth: The global market is experiencing significant growth driven by increasing prevalence of ocular diseases, advanced healthcare infrastructure, and regulatory support.
• Regional Dynamics: North America and Europe are leading markets, while Asia-Pacific and Middle East & Africa are emerging as potential growth areas.
• Competitive Landscape: Market leaders are innovating through advanced technologies and strategic partnerships.
• Future Trends: Innovative formulations and government initiatives are expected to drive further market growth.

FAQs

Q: What is bromfenac sodium used for?

Bromfenac sodium is used for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery.

Q: What are the key findings from clinical trials on bromfenac sodium?

Clinical trials have shown that bromfenac sodium is superior to vehicle in reducing ocular inflammation and pain, with significant differences in the proportion of subjects with cleared ocular inflammation and those who were pain-free.

Q: Which regions are leading the bromfenac sodium market?

North America, particularly the United States, and Europe, especially Germany and the UK, are leading the market due to their advanced healthcare infrastructure and high patient awareness.

Q: What are the future trends in the bromfenac sodium market?

The introduction of innovative formulations, such as preservative-free eye drops, and government initiatives aimed at improving healthcare access and affordability are expected to drive future market growth.

Q: What is the projected growth rate of the bromfenac sodium market?

The market is projected to grow at a compound annual growth rate (CAGR) of around 6% over the next several years.

Sources

1. FDA Document: "203168Orig1s000 - accessdata.fda.gov"
2. PMR Report: "Worldwide Bromfenac Sodium Market Research 2024 by Type, Application, Participants, and Countries Forecast to 2030"
3. Biospace Article: "ISTA Pharmaceuticals, Inc. Presents Results from Two Phase III Clinical Trials of Xibrom™ QD"
4. Journal Article: "Efficacy and safety of sodium bromfenac eye drops in the treatment of postoperative inflammation of cataract surgery"
5. Insight Partners Report: "Bromfenac Sodium Market Key Players Analysis 2031"