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Gatifloxacin 0.3%
Gatifloxacin 0.3% is an ophthalmic solution developed by Innovative Medical for the treatment of bacterial conjunctivitis. Despite its efficacy, it has not received FDA approval, which may limit its market potential. The drug belongs to the fluoroquinolone class and works by inhibiting bacterial DNA gyrase and topoisomerase IV, essential enzymes for bacterial replication. Common side effects include eye irritation, itching, and redness, occurring in about 5-10% of patients. Due to the lack of FDA approval, its commercial performance is limited, and it faces significant competition from approved alternatives.
At a glance
| Generic name | Gatifloxacin 0.3% |
|---|---|
| Sponsor | Innovative Medical |
| Drug class | Fluoroquinolone |
| Target | DNA gyrase and topoisomerase IV |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | FDA-approved |
Approved indications
Pipeline indications
Common side effects
Key clinical trials
- Efficacy of the Ophthalmic Pazufloxacin 0.6% for Bacterial Conjunctivitis, Compared to Gatifloxacin 0.3%. (PHASE3)
- Safety and Efficacy of PRO-157 vs Moxifloxacin vs Gatifloxacin in Patients With Bacterial Conjunctivitis (Pazufloxacin) (PHASE2)
- Non-Inferiority of Gatifloxacin/Prednisolone Association vs Isolated Administration in Prevention of Ocular Infection/Inflammation (PHASE3)
- Besifloxacin Ophthalmic Suspension Verses Gatifloxacin Ophthalmic Solution in Neonates With Bacterial Conjunctivitis (PHASE3)
- A Clinical Study to Evaluate if Benzalkonium Chloride (BAK) in a Quinolone Eyedrop Reduces the Likelihood of Developing Resistant Organisms (PHASE4)
- Assessment of the Concentrations of Besifloxacin, Moxifloxacin, or Gatifloxacin in the Aqueous Humor of Subjects (PHASE1)
- Concentration of Besifloxacin, Gatifloxacin, and Moxifloxacin in Human Conjunctiva After Topical Instillation (PHASE1)
- Effect of Moxifloxacin Versus Gatifloxacin on Corneal Epithelium Following Pterygium Excision (NA)
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:
- Gatifloxacin 0.3% CI brief — competitive landscape report
- Gatifloxacin 0.3% updates RSS · CI watch RSS
- Innovative Medical portfolio CI