Last reviewed · How we verify
AzaSite®
AzaSite is an azithromycin ophthalmic suspension that reduces bacterial load and inflammatory mediators in the eye to treat bacterial conjunctivitis and meibomian gland dysfunction.
AzaSite is an azithromycin ophthalmic suspension that reduces bacterial load and inflammatory mediators in the eye to treat bacterial conjunctivitis and meibomian gland dysfunction. Used for Bacterial conjunctivitis, Meibomian gland dysfunction (dry eye disease).
At a glance
| Generic name | AzaSite® |
|---|---|
| Also known as | AzaSite, Azithromycin ophthalmic 1% |
| Sponsor | Merck Sharp & Dohme LLC |
| Drug class | Macrolide antibiotic |
| Target | Bacterial 50S ribosomal subunit |
| Modality | Small molecule |
| Therapeutic area | Ophthalmology |
| Phase | FDA-approved |
Mechanism of action
Azithromycin is a macrolide antibiotic that inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit. In addition to direct antimicrobial activity, azithromycin has immunomodulatory properties that reduce inflammatory cytokines and mucin hypersecretion in ocular tissues, making it effective for both infectious and inflammatory ocular conditions.
Approved indications
- Bacterial conjunctivitis
- Meibomian gland dysfunction (dry eye disease)
Common side effects
- Eye irritation
- Conjunctival hyperemia
- Ocular discomfort
- Taste perversion
Key clinical trials
- Efficacy + Safety of Liposome Cyclosporine A to Treat Bronchiolitis Obliterans Post Double Lung Transplant (BOSTON-2) (PHASE3)
- Study to Evaluate ALIS (Amikacin Liposome Inhalation Suspension) in Participants With Nontuberculous Mycobacterial Lung Infection Caused by Mycobacterium Avium Complex (PHASE3)
- Efficacy + Safety of Liposome Cyclosporine A to Treat Bronchiolitis Obliterans Post Single Lung Transplant (BOSTON-1) (PHASE3)
- THE EFFECT OF NEBULIZED AZITHROMYCIN AS THERAPY FOR BRONCHOPULMONARY DYSPLASIA (PHASE4)
- Effect of Topical Azithromycin on Tear Film Thickness in Patients With Meibomian Gland Dysfunction (PHASE4)
- A Trial of Placebo Versus Macrolide for Mycoplasma Pneumoniae Childhood Pneumonia: MYTHIC Study (NA)
- Effects of Probiotic in Treatment of Persistent Diarrhea in Children (NA)
- A Relative Bioavailability Study of 200mg/5 mL Azithromycin Oral Suspension Under Non-Fasting Conditions (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- AzaSite® CI brief — competitive landscape report
- AzaSite® updates RSS · CI watch RSS
- Merck Sharp & Dohme LLC portfolio CI