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Azithromycin Ophthalmic Solution, 1%
Azithromycin Ophthalmic Solution, 1% is a Macrolide antibiotic Small molecule drug developed by Merck Sharp & Dohme LLC. It is currently FDA-approved for Bacterial conjunctivitis, Bacterial keratitis.
Azithromycin is a macrolide antibiotic that inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit, thereby killing or stopping the growth of susceptible bacteria.
Azithromycin Ophthalmic Solution, 1% is used to treat bacterial conjunctivitis, blepharitis, posterior blepharoconjunctivitis, bacterial infections, and eye infections. It is compared to other treatments such as Tobramycin in clinical studies for its efficacy and safety.
At a glance
| Generic name | Azithromycin Ophthalmic Solution, 1% |
|---|---|
| Sponsor | Merck Sharp & Dohme LLC |
| Drug class | Macrolide antibiotic |
| Target | Bacterial 50S ribosomal subunit |
| Modality | Small molecule |
| Therapeutic area | Ophthalmology / Infectious Disease |
| Phase | FDA-approved |
Mechanism of action
Azithromycin binds to the bacterial 50S ribosomal subunit and inhibits transpeptidation and translocation, preventing peptide bond formation and halting protein synthesis. When formulated as an ophthalmic solution, it achieves high local concentrations in ocular tissues to treat bacterial infections of the eye. The drug is bactericidal against a broad spectrum of gram-positive and gram-negative organisms commonly associated with ocular infections.
Approved indications
- Bacterial conjunctivitis
- Bacterial keratitis
Common side effects
- Eye irritation
- Conjunctival hyperemia
- Ocular discomfort
- Blurred vision
Key clinical trials
- Effect of Topical Azithromycin on Tear Film Thickness in Patients With Meibomian Gland Dysfunction (PHASE4)
- Efficacy of Over the Counter (OTC) Povidone-Ioldine 5% for Treatment of Acute or Chronic Blepharitis (NA)
- Local Pharmacokinetics of Azithromycin Eye Drops in Healthy Volunteers (PHASE1)
- Antibiotic Steroid Combination Compared With Individual Administration in the in the Treatment of Ocular Inflammation and Infection (PHASE3)
- Efficacy and Safety Assessment of Azyter® Eye Drops (T1225) in Patients With Blepharitis (PHASE2)
- A Four Week, Open-Label Study of Azithromycin Ophthalmic Solution, 1% (P08641) (PHASE2)
- Evaluation of Clinical and Microbial Efficacy and Safety of AzaSite Compared to Tobramycin for Bacterial Conjunctivitis (C-01-401-004) (PHASE3)
- A Four Week Study of Azithromycin Ophthalmic Solution, 1% Versus Vehicle in Subjects With Blepharitis (P08636) (PHASE2)
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:
- Azithromycin Ophthalmic Solution, 1% CI brief — competitive landscape report
- Azithromycin Ophthalmic Solution, 1% updates RSS · CI watch RSS
- Merck Sharp & Dohme LLC portfolio CI
Frequently asked questions about Azithromycin Ophthalmic Solution, 1%
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Related
- Drug class: All Macrolide antibiotic drugs
- Target: All drugs targeting Bacterial 50S ribosomal subunit
- Manufacturer: Merck Sharp & Dohme LLC — full pipeline
- Therapeutic area: All drugs in Ophthalmology / Infectious Disease
- Indication: Drugs for Bacterial conjunctivitis
- Indication: Drugs for Bacterial keratitis
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing