BESIVANCE (besifloxacin hydrochloride)
BESIVANCE is indicated for the treatment of Bacterial Conjunctivitis.
How BESIVANCE Works
Besifloxacin is a fluoroquinolone that exerts its antibacterial activity by inhibiting bacterial DNA gyrase and topoisomerase IV. DNA gyrase is an essential enzyme involved in the replication, transcription, and repair of bacterial DNA. Topoisomerase IV is required for the partitioning of chromosomal DNA during bacterial cell division. This dual mechanism of action results in the inhibition of bacterial DNA synthesis and subsequent cell death.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2009-05-28
- Patent Cliff
- 2031
- Routes
- OPHTHALMIC
- Dosage Forms
- SUSPENSION/DROPS
BESIVANCE Approval History
What BESIVANCE Treats
1 indicationsBESIVANCE is approved for 1 conditions since its original approval in 2009. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Bacterial Conjunctivitis
BESIVANCE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to BESIVANCE
3 of 7FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
8 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01296191 results posted | 2011-BV-A | Ph 4 | completed | Aqueous Absorption and Pharmacokinetics of Besivance Versus VIGAMOX in Patients Undergoing Phacoemulsification |
| NCT01740388 results posted | 801 | Ph 3 | terminated | Clinical and Microbial Efficacy of Besifloxacin Ophthalmic Suspension, 0.6% in the Treatment of Bacterial Conjunctivitis |
| NCT01330355 results posted | 646 | Ph 3 | terminated | Besifloxacin Ophthalmic Suspension Verses Gatifloxacin Ophthalmic Solution in Neonates With Bacterial Conjunctivitis |
| NCT01175590 results posted | 631 | Ph 3 | completed | Safety of Besivance™ (Besifloxacin Ophthalmic Suspension) 0.6% Compared to Vehicle |
| NCT00972777 results posted | 603 | Ph 2, Ph 3 | completed | Efficacy of Besifloxacin Ophthalmic Suspension in the Treatment of Bacterial Conjunctivitis |
| NCT00824070 results posted | 575 | Ph 1 | completed | Assessment of the Concentrations of Besifloxacin, Moxifloxacin, or Gatifloxacin in the Aqueous Humor of Subjects |
| NCT00905762 | 608 | Ph 1 | completed | Concentration of Besifloxacin, Gatifloxacin, and Moxifloxacin in Human Conjunctiva After Topical Instillation |
| NCT01455233 STB-01 | STB-01 | Ph 4 | completed | 2-Site Safety Study of Besivance Versus Vigamox Prophylactically in Routine Cataract Surgery |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
BESIVANCE FDA Label Details
Indications & Usage
FDA Label (PDF)BESIVANCE is indicated for the treatment of Bacterial Conjunctivitis.
Pro Intelligence Preview
Deep insights for BESIVANCE
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2031
- • 4 active patents
Trial Analysis
- • 8 total trials
- • Stage: Declining
Competitive Landscape
- • 7 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment