CLINICAL TRIALS PROFILE FOR AZASITE

505(b)(2) Clinical Trials for AZASITE

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	NCT01560962 ↗	Efficacy of Over the Counter (OTC) Povidone-Ioldine 5% for Treatment of Acute or Chronic Blepharitis	Terminated	Southern California Institute for Research and Education	N/A	2012-01-01	Objective: To determine the preliminary outcome of external over the counter (OTC) povidone iodine (PI) application in the management of chronic and acute blepharitis vs. currently clinically accepted medical regimen, i.e. eyelid hygiene, antibiotic drops, or antibiotic/steroid ointments. Methodology: One hundred adult patients with chronic and acute blepharitis will be enrolled and randomized into four groups. In group one, 25 patients will be instructed to scrub the lid margin of one eye with 5% PI twice daily for 10 days and the other eye with no intervention. In group two, 25 patients will be instructed to scrub the lid margin of one eye with 5% PI and the other eye will receive warm soaked eyelid wash. In group three, 25 patients will be instructed to scrub the lid margin of one eye with 5% PI and the other eye will receive 1 drop of azithromycin ophthalmic solution twice daily for 10 days. In group four, 25 patients will be instructed to scrub the lid margin of one eye with 5% PI and the other eye will receive tobradex ointment applied to the lid margin. Subjective variables assessed included itchiness, foreign body sensation and eyelid edema (grade 0-4). Objective variables assessed included lid margin redness, meibomian gland plugging and presence/absence of collarets (grade 0-4). Cultures of lid margin at the initiation and at the cessation of treatment were obtained.

All Clinical Trials for AZASITE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00105469 ↗	Evaluation of Clinical and Microbial Efficacy and Safety of AzaSite Compared to Tobramycin for Bacterial Conjunctivitis (C-01-401-004)	Completed	Merck Sharp & Dohme Corp.	Phase 3	2004-07-01	The purpose of this study is to evaluate the clinical and microbial efficacy and safety of AzaSite compared to tobramycin for bacterial conjunctivitis. Adults and children one year of age and older with bacterial conjunctivitis in at least one eye are eligible. Subjects will be randomly assigned to the AzaSite group or Tobramycin group. Three visits will be required for the study.
NCT00105534 ↗	Evaluation of Clinical and Microbial Efficacy and Safety of AzaSite Compared to Vehicle for Bacterial Conjunctivitis (C-01-401-003)	Completed	Merck Sharp & Dohme Corp.	Phase 3	2004-07-01	The purpose of this study is to evaluate the clinical and microbial efficacy and safety of AzaSite compared to vehicle for bacterial conjunctivitis. Adults and children one year of age and older with bacterial conjunctivitis in at least one eye may be eligible. Subjects will be randomly assigned to receive either 1.0 % AzaSite or Vehicle. Three visits will be required for this study.
NCT00564447 ↗	Study of AzaSite (Azithromycin) Versus Vigamox in the Conjunctiva of Healthy Volunteers	Completed	Merck Sharp & Dohme Corp.	Phase 4	2007-12-01	The purpose of this study is to evaluate the drug concentrations of AzaSite™ compared to Vigamox at various time points in conjunctiva tissue of healthy volunteers
NCT00575367 ↗	Study of AzaSite Versus Vigamox in the Tears of Healthy Volunteers	Completed	Merck Sharp & Dohme Corp.	Phase 4	2008-03-01	The purpose of this study is to evaluate the drug concentrations of AzaSite compared to Vigamox in tears of healthy volunteers
NCT00575380 ↗	Study of AzaSite Versus Vigamox Concentrations in the Conjunctiva and Aqueous Humor in Subjects Undergoing Routine Cataract Surgery	Completed	Merck Sharp & Dohme Corp.	Phase 4	2007-12-01	The purpose of this study is to evaluate the drug concentrations in the conjunctiva and aqueous humor of AzaSite™ compared to Vigamox® in subjects undergoing routine cataract surgery

Clinical Trial Conditions for AZASITE

Condition Name

Condition Name for AZASITE
Intervention	Trials
Blepharitis	8
Bacterial Infections	3
Eye Infections	3
Blepharoconjunctivitis	2

Condition MeSH

Condition MeSH for AZASITE
Intervention	Trials
Blepharitis	8
Conjunctivitis	4
Infections	3
Infection	3

Clinical Trial Locations for AZASITE

Trials by Country

Trials by Country for AZASITE
Location	Trials
United States	90

Trials by US State

Trials by US State for AZASITE
Location	Trials
New York	9
California	6
Florida	6
Kentucky	5
Texas	5

Clinical Trial Progress for AZASITE

Clinical Trial Phase

Clinical Trial Phase for AZASITE
Clinical Trial Phase	Trials
Phase 4	8
Phase 3	6
Phase 2	2

Clinical Trial Status

Clinical Trial Status for AZASITE
Clinical Trial Phase	Trials
Completed	14
Withdrawn	2
Terminated	1

Clinical Trial Sponsors for AZASITE

Sponsor Name

Sponsor Name for AZASITE
Sponsor	Trials
Merck Sharp & Dohme Corp.	10
InSite Vision	3
Sun Pharma Global FZE	3

Sponsor Type

Sponsor Type for AZASITE
Sponsor	Trials
Industry	17
Other	6
NIH	1

Clinical Trials Update, Market Analysis, and Projection for Azasite

Last updated: November 2, 2025

Introduction

Azasite (azithromycin ophthalmic solution 1%) is a targeted antibiotic treatment primarily approved for bacterial conjunctivitis and other anterior segment infections. Since its FDA approval in 2008, Azasite has carved out a niche in ophthalmic antibiotics, leveraging the widespread prevalence of bacterial eye infections. This report offers a comprehensive update on Azasite’s ongoing clinical trials, current market landscape, and future market projections to inform industry stakeholders and healthcare decision-makers.

Clinical Trials Update

Recent and Ongoing Clinical Trial Landscape

Since its launch, Azasite has undergone several clinical evaluations to expand its indications and optimize its efficacy and safety profile. The most recent updates focus on its off-label use for additional ocular infections and potential resistance issues.

• Expansion of Indications: Trials initiated post-2018 involve evaluating Azasite’s efficacy in treating keratitis, particularly bacterial keratitis resistant to standard therapies. Such studies aim to broaden its application beyond conjunctivitis, supported by preliminary data indicating promising antimicrobial coverage.

• Resistance and Safety Studies: Recognizing increasing antibiotic resistance, recent trials focus on assessing Azasite’s potency against resistant strains like Pseudomonas aeruginosa, Staphylococcus aureus, and Haemophilus influenzae. These studies aim to establish its utility as a treatment option amid rising antimicrobial resistance (AMR).

• Comparative Effectiveness Trials: Several phase IV studies compare Azasite directly with other topical antibiotics such as moxifloxacin and erythromycin. Early results suggest Azasite maintains comparable efficacy and a favorable safety profile, though differences in resistance patterns demand ongoing surveillance.

Regulatory and Developmental Updates

While no recent FDA updates or approvals beyond the original indication have been announced, ongoing clinical trials are exploring further off-label uses, including postoperative prophylaxis and combination therapies, reflective of evolving clinical practice needs.

Future Clinical Trial Directions

Moving forward, Azasite's clinical research aims to:

1. Validate its efficacy in resistant bacterial strains.
2. Investigate its role in prophylaxis post ocular surgeries.
3. Evaluate potential pediatric applications, as children represent a substantial subset of eye infection patients.

Conclusion on Clinical Trials

Azasite’s clinical development trajectory emphasizes its repositioning within the broader ophthalmic antimicrobial landscape. While primary indications remain well-established, expanding evidence on its efficacy against resistant pathogens and in prophylactic settings could significantly influence its clinical adoption.

Market Analysis

Market Overview

The global ophthalmic antibiotics market was valued at approximately USD 1.2 billion in 2022, with a compound annual growth rate (CAGR) forecast of 4.3% through 2030. Azasite holds a prominent position, especially within the North American market, owing to its unique formulation designed for local application, which reduces systemic side effects typical of oral antibiotics.

Market Drivers

• Rising Incidence of Bacterial Eye Infections: An increase in conjunctivitis, keratitis, and other bacterial ocular infections fuels demand for effective topical antibiotics.

• Antibiotic Resistance Concerns: Growing resistance to systemic antibiotics favors localized therapies like Azasite, which achieve high tissue concentrations with minimal systemic absorption.

• Patient Preference for Convenient Formulations: Azasite’s once or twice daily dosing enhances patient compliance, especially among pediatric and elderly populations.

Market Challenges

• Competition from Generic and Branded Formulations: Moxifloxacin (Vigamox), besifloxacin, and off-label use of systemic antibiotics limit Azasite’s market share.
• Pricing and Reimbursement Dynamics: As patent protections expire or if new entrants emerge, pricing pressures could impact margins.
• Limited Indications: Currently approved only for certain bacterial eye infections, restricting market expansion.

Key Market Players

Major competitors include Alcon (Vigamox), Bausch + Lomb (Besifloxacin), and other pipeline agents under clinical investigation. These companies’ aggressive marketing strategies and pipeline development pose continuous challenges for Azasite’s market penetration.

Regional Market Insights

• North America: Dominates due to established clinical guidelines and high awareness. Azasite’s share here remains robust, driven by insurance reimbursements and physician advocacy.
• Europe: Regulatory pathways are nuanced, with some markets more receptive to topical antibiotics.
• Asia-Pacific: Rapidly expanding due to increasing burden of ocular infections, though price sensitivity and regulatory hurdles influence uptake.

Market Projection and Future Outlook

Short-term (2023-2025)

• Growth driven by increased clinician awareness of Azasite’s efficacy, especially for resistant infections.
• Initiatives to expand approved indications could bolster sales.
• Competition's pricing pressures may moderate growth rates.

Mid to Long-term (2025-2030)

• If ongoing clinical trials demonstrate Azasite’s superior efficacy against resistant strains, adoption could accelerate.
• Potential expansion into prophylactic use following ocular surgeries and pediatric applications.
• The emergence of biosimilars or generics may influence profitability, but brand loyalty and clinical preference for Azasite-derived formulations may impede immediate price erosion.
• Strategic collaborations for combination therapies could unlock new market segments.

Growth Potential

Analysts project a CAGR of approximately 4-5% through 2030, contingent on successful clinical trials, expanding indications, and regulatory approvals. The focus on combating antimicrobial resistance and patient compliance trends favor Azasite’s niche positioning, provided the clinical benefits are substantiated.

Key Takeaways

• Clinical evidence indicates ongoing efforts to broaden Azasite’s applications, particularly in resistant infections and prophylaxis, which could enhance market adoption.
• Market dynamics are heavily influenced by competition from systemic antibiotics and other topical agents, demanding strategic differentiation and targeted marketing.
• The rising prevalence of bacterial ocular infections and resistance issues support the sustained demand for effective topical antibiotics like Azasite.
• Future growth hinges on successful clinical trial outcomes, regulatory approvals for expanded indications, and strategic positioning within an increasingly competitive landscape.
• Price stability and insurance reimbursement policies will significantly impact sales trajectories over the coming years.

FAQs

Q1: Can Azasite be used for bacterial keratitis treatment?
A: Currently, Azasite is primarily approved for bacterial conjunctivitis. Ongoing clinical trials aim to assess its efficacy for keratitis, but it is not yet an FDA-approved indication.

Q2: How does Azasite compare to other topical antibiotics in terms of resistance?
A: Studies suggest Azasite maintains activity against certain resistant strains, but resistance patterns vary. Continued surveillance and clinical trials are essential to confirm its comparative advantage.

Q3: Are there any emerging formulations or combination therapies involving Azasite?
A: Researchers are exploring combination therapies and formulations to enhance efficacy against resistant infections, but no such products have gained regulatory approval yet.

Q4: What is the patent landscape for Azasite?
A: Dominant patents have expired or are close to expiry, exposing Azasite to generic competition. Proprietary formulations or delivery mechanisms may provide some protective barriers.

Q5: What are the main barriers to Azasite’s market expansion?
A: Competition from established antibiotics, limited indications, pricing pressures, and regulatory hurdles are primary challenges restricting broader adoption.

References

1. Market research reports on ophthalmic antibiotics, 2022.
2. FDA Clinical Trials Registry, ongoing ophthalmic drug trials.
3. Latest peer-reviewed publications on azithromycin resistance, 2022-2023.
4. Industry analyses on global ophthalmic pharmaceuticals, 2023.
5. Regulatory updates and approvals from U.S. FDA and European Medicines Agency.

Note: This analysis is based on publicly available information as of early 2023 and ongoing clinical trial updates; actual market dynamics may evolve with new developments.