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Last Updated: January 14, 2025

CLINICAL TRIALS PROFILE FOR VIGAMOX


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All Clinical Trials for Vigamox

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00312338 ↗ Topical Treatment of Bacterial Conjunctivitis and Its Effect on Microbial Flora Completed Tufts University Phase 4 2006-06-01 Topical Treatment of Bacterial Conjunctivitis and its Effect on Microbial Flora
NCT00312338 ↗ Topical Treatment of Bacterial Conjunctivitis and Its Effect on Microbial Flora Completed Alcon Research Phase 4 2006-06-01 Topical Treatment of Bacterial Conjunctivitis and its Effect on Microbial Flora
NCT00324168 ↗ Steroids for Corneal Ulcers Trial Completed Aravind Eye Hospitals, India Phase 4 2006-09-01 The purpose of this study is to determine whether adding topical steroids improves the outcomes of bacterial corneal ulcers, especially visual acuity.
NCT00324168 ↗ Steroids for Corneal Ulcers Trial Completed Dartmouth-Hitchcock Medical Center Phase 4 2006-09-01 The purpose of this study is to determine whether adding topical steroids improves the outcomes of bacterial corneal ulcers, especially visual acuity.
NCT00324168 ↗ Steroids for Corneal Ulcers Trial Completed National Eye Institute (NEI) Phase 4 2006-09-01 The purpose of this study is to determine whether adding topical steroids improves the outcomes of bacterial corneal ulcers, especially visual acuity.
NCT00324168 ↗ Steroids for Corneal Ulcers Trial Completed Thomas M. Lietman Phase 4 2006-09-01 The purpose of this study is to determine whether adding topical steroids improves the outcomes of bacterial corneal ulcers, especially visual acuity.
NCT00332293 ↗ AL-15469A for the Treatment of Bacterial Conjunctivitis Completed Alcon Research Phase 3 2006-05-01 The purpose of the study is to determine whether AL-15469A is safe and effective in the treatment of bacterial conjunctivitis.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Vigamox

Condition Name

Condition Name for Vigamox
Intervention Trials
Cataract Extraction 4
Bacterial Conjunctivitis 4
Endophthalmitis 4
Eye Infections 3
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Condition MeSH

Condition MeSH for Vigamox
Intervention Trials
Cataract 9
Endophthalmitis 5
Conjunctivitis, Bacterial 5
Conjunctivitis 5
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Clinical Trial Locations for Vigamox

Trials by Country

Trials by Country for Vigamox
Location Trials
United States 32
Brazil 4
Egypt 3
Israel 2
Canada 1
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Trials by US State

Trials by US State for Vigamox
Location Trials
Missouri 5
New York 4
California 3
Texas 3
Pennsylvania 2
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Clinical Trial Progress for Vigamox

Clinical Trial Phase

Clinical Trial Phase for Vigamox
Clinical Trial Phase Trials
Phase 4 16
Phase 3 4
Phase 2 4
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Clinical Trial Status

Clinical Trial Status for Vigamox
Clinical Trial Phase Trials
Completed 21
Recruiting 5
Terminated 2
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Clinical Trial Sponsors for Vigamox

Sponsor Name

Sponsor Name for Vigamox
Sponsor Trials
Alcon Research 5
Bausch & Lomb Incorporated 3
Merck Sharp & Dohme Corp. 3
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Sponsor Type

Sponsor Type for Vigamox
Sponsor Trials
Other 32
Industry 16
NIH 1
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VIGAMOX: Clinical Trials, Market Analysis, and Projections

Introduction

VIGAMOX, a moxifloxacin hydrochloride ophthalmic solution, is a widely used topical fluoroquinolone antibiotic for the treatment of bacterial conjunctivitis. Here, we delve into the clinical trials, market analysis, and future projections for this medication.

Clinical Trials and Efficacy

Adult and Pediatric Studies

VIGAMOX has been supported by evidence from adequate and well-controlled studies in adults, children, and neonates. In two randomized, double-masked, multicenter clinical trials, VIGAMOX demonstrated clinical cure rates of 66% to 69% in patients treated for bacterial conjunctivitis, with microbiological success rates ranging from 84% to 94%[1].

For pediatric patients, particularly those between birth and 31 days of age, VIGAMOX showed a clinical cure rate of 80% and a microbiological eradication success rate of 92% at Day 9[1].

Safety Profile

The safety profile of VIGAMOX includes ocular adverse events such as ocular hyperemia, ocular pain, ocular pruritus, subconjunctival hemorrhage, and tearing, which occurred in approximately 1%-6% of patients. Nonocular adverse events, including fever, increased cough, infection, otitis media, pharyngitis, rash, and rhinitis, were reported in 1%-4% of patients[1][4].

Market Analysis

Current Market Status

The bacterial conjunctivitis market, in which VIGAMOX is a key player, was valued at USD 3.0 billion in 2023. This market is expected to grow, driven by factors such as increasing prevalence of bacterial conjunctivitis and advancements in treatment options[2].

Market Trends

The market for bacterial conjunctivitis drugs is undergoing significant changes. The topical fluoroquinolones segment, which includes VIGAMOX, Zymaxid, and Moxeza, is expected to decline due to patent expirations and the emergence of new treatment options, including probiotic-based interventions and herbal treatments[3].

Strategic Moves

Harrow, the current owner of the US commercial rights to VIGAMOX, has completed the New Drug Application (NDA) transfer, making the drug commercially available under the Harrow name. This move is part of Harrow's strategy to expand the market reach of VIGAMOX through strategic partnerships and increased availability in various regions, particularly in emerging markets where bacterial conjunctivitis is prevalent[4].

Market Projections

Growth Potential

Despite the expected decline in the topical fluoroquinolones segment, VIGAMOX remains a trusted and reliable product among US eye care professionals. The overall ophthalmic drugs market, including the segment for allergic, inflammatory, and infective drugs, is projected to see significant growth. Emerging economies, particularly in South America and Asia, are expected to drive this growth due to increasing healthcare spending and access to advanced treatments[5].

Regional Analysis

The market for ophthalmic drugs, including VIGAMOX, is forecasted to grow in various regions. The US, China, Japan, India, and other leading national markets are expected to contribute significantly to the overall revenue growth. Emerging markets will play a crucial role in the future growth of the ophthalmic drugs market, including the bacterial conjunctivitis segment[5].

Competitive Landscape

VIGAMOX faces competition from other ophthalmic drugs, but its established reputation and broad-spectrum efficacy make it a preferred choice for many eye care professionals. The market is also seeing the entry of new players and innovative treatments, which could impact the market share of existing drugs like VIGAMOX. However, strategic partnerships and market expansion efforts by Harrow are likely to maintain VIGAMOX's competitive edge[4].

Future Outlook

Emerging Trends

The shift towards herbal and probiotic-based treatments is a significant trend in the bacterial conjunctivitis market. However, VIGAMOX's proven safety and efficacy profile, combined with its broad-spectrum antibacterial activity, ensure it remains a viable treatment option. The integration of new technologies and treatment modalities will continue to shape the market, but VIGAMOX is well-positioned to adapt to these changes[3].

Regulatory and Commercial Strategies

Harrow's acquisition of the US commercial rights to VIGAMOX and other ophthalmic products underscores the company's commitment to expanding its market presence. The completion of the NDA transfer and the implementation of market access, marketing, and inventory management strategies will be crucial in maintaining VIGAMOX's market share and driving future growth[4].

Key Takeaways

  • Clinical Efficacy: VIGAMOX has demonstrated strong clinical and microbiological success rates in treating bacterial conjunctivitis.
  • Safety Profile: The drug has a well-documented safety profile with manageable adverse events.
  • Market Trends: The market is shifting towards new treatment options, but VIGAMOX remains a trusted product.
  • Market Projections: The ophthalmic drugs market, including the bacterial conjunctivitis segment, is expected to grow significantly, driven by emerging markets.
  • Competitive Landscape: VIGAMOX faces competition but maintains a competitive edge through strategic partnerships and market expansion.

FAQs

Q: What is VIGAMOX used for?

A: VIGAMOX is used for the treatment of bacterial conjunctivitis caused by susceptible strains of organisms.

Q: What are the common adverse events associated with VIGAMOX?

A: Common adverse events include ocular hyperemia, ocular pain, ocular pruritus, subconjunctival hemorrhage, and tearing, as well as nonocular events like fever and increased cough.

Q: Who is the current owner of the US commercial rights to VIGAMOX?

A: Harrow is the current owner of the US commercial rights to VIGAMOX.

Q: What is the expected growth of the bacterial conjunctivitis market?

A: The bacterial conjunctivitis market is expected to reach USD 4.3 billion by 2034, driven by various factors including new treatment options and increasing prevalence.

Q: How is Harrow expanding the market reach of VIGAMOX?

A: Harrow is expanding the market reach of VIGAMOX through strategic partnerships, increasing availability in various regions, and implementing market access and marketing strategies.

Sources

  1. Novartis. VIGAMOX® (moxifloxacin ophthalmic solution), for topical ophthalmic use.
  2. Biospace. Bacterial Conjunctivitis Market Size to Reach USD 4.3 Billion by 2034.
  3. Biospace. Bacterial Conjunctivitis Drugs Market: Shift to Herbal Treatment from Pharmaceutical Medication will Boost the Market.
  4. Optometry Times. Harrow celebrates Vigamox US launch.
  5. PR Newswire. Ophthalmic Drugs Market Forecast 2015-2025: Prospects for Leading Companies in Dry Eye, Glaucoma, Retinal Disorders, Allergic, Inflammatory & Infective Drugs.

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