NDAOPHTHALMICSUSPENSION/DROPS
Approved
May 2009
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
8
Data completeness
7/8 — Comprehensive
BESIVANCE (besifloxacin) by Bausch + Lomb is [see microbiology ( )] . Approved for bacterial conjunctivitis. First approved in 2009.
Drug data last refreshed 20h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
BESIVANCE (besifloxacin) is a fluoroquinolone antimicrobial ophthalmic suspension approved by the FDA in May 2009 for the treatment of bacterial conjunctivitis. It demonstrates broad-spectrum activity against common ocular pathogens including Staphylococcus aureus, Haemophilus influenzae, Streptococcus pneumoniae, and Pseudomonas aeruginosa. Administered as topical eye drops, besifloxacin works by inhibiting bacterial DNA gyrase and topoisomerase IV, disrupting DNA replication. BESIVANCE is positioned as a first-line topical antibiotic for acute bacterial conjunctivitis in both pediatric and adult populations.
$0.0BPart D
4.7 years to LOEMechanism of Action
[see Microbiology ( )] .
Pharmacologic Class:
Quinolone Antimicrobial
Indications (1)
Clinical Trials (8)
Clinical and Microbial Efficacy of Besifloxacin Ophthalmic Suspension, 0.6% in the Treatment of Bacterial Conjunctivitis
Started Feb 2013
136 enrolled
Bacterial Conjunctivitis
Safety and Efficacy Study of Besivance™ for Treatment of Congenital Nasolacrimal Duct Obstruction in Children
Started Sep 2011
24 enrolled
Congenital Nasolacrimal Duct Obstruction
Besifloxacin Ophthalmic Suspension Verses Gatifloxacin Ophthalmic Solution in Neonates With Bacterial Conjunctivitis
Started May 2011
33 enrolled
Bacterial Conjunctivitis
2-Site Safety Study of Besivance Versus Vigamox Prophylactically in Routine Cataract Surgery
Started Sep 2010
60 enrolled
Corneal HealthCataract Surgery
Safety of Besivance™ (Besifloxacin Ophthalmic Suspension) 0.6% Compared to Vehicle
Started Jun 2010
518 enrolled
Bacterial Conjunctivitis
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.