NDAOPHTHALMICSUSPENSION/DROPS
Approved
May 2009
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
8
Data completeness
6/8 — Strong
BESIVANCE (besifloxacin) by Bausch + Lomb is [see microbiology ( )] . First approved in 2009.
Drug data last refreshed 10h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Besivance is a fluoroquinolone antibiotic ophthalmic suspension approved in 2009 for bacterial eye infections. It works by inhibiting bacterial DNA gyrase and topoisomerase IV, disrupting DNA replication in susceptible pathogens. The drug is administered as topical eye drops and represents a quinolone class antimicrobial for ocular use.
$0.011BPart D
Peak4.3 years to LOEProduct is at peak lifecycle maturity with modest Part D utilization (~46K claims in 2023), suggesting a stable but limited commercial footprint typical of mature ophthalmic antibiotics.
Mechanism of Action
[see Microbiology ( )] .
Pharmacologic Class:
Quinolone Antimicrobial
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
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.