Besivance

(Besifloxacin)

ApprovedSmall molecule

BBausch Health Americas, Inc.

Besivance is one of 65 small molecule programs targeting Bacterial Conjunctivitis. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Bacterial ConjunctivitisActive, not recruiting

KeratitisActive, not recruiting

CataractActive, not recruiting

Bacterial ConjunctivitisPhase 3

Active, not recruiting

KeratitisPreclinical

Active, not recruiting

CataractApproved

Active, not recruiting

Competition

Competitive Landscape

219 competitors in Cataract

#DrugCompanyPhaseTrials

Besivance

BBausch Health Americas, Inc.

Approved

2 2

Tetracaine Hydrochloride

BBausch Health Americas, Inc.

Phase 3

1 3

ISV-305

Sun Pharmaceutical Industries Limited

Phase 3

2 4

KPI-121

KKala Pharmaceuticals, Inc.

Phase 3

1 5

Midalozam

Idorsia Pharmaceuticals Ltd.

Phase 3

2 6

XG-102

XXigen SA

Phase 3

2 7

Zolymbus

AbbVie

Preclinical

—8

Neurontin

VViatris Specialty LLC

Preclinical

3 9

Kenalog

BBassett Healthcare

Preclinical

1 10

Xylocaine

MMEDRx USA, Inc.

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Clinical

Trials by Indication[1]

Bacterial Conjunctivitis3 trials

A Study to Investigate the Safety and Efficacy of BOL-303224 in the Treatment of Bacterial Conjunctivitis

Completed·BBausch & Lomb Incorporated·Phase 3·NCT00348348·1,161 enrolled

Clinical and Microbial Efficacy of Besifloxacin Ophthalmic Suspension, 0.6% in the Treatment of Bacterial Conjunctivitis

Terminated·BBausch & Lomb Incorporated·Phase 3·NCT01740388·136 enrolled

Efficacy of Besifloxacin Ophthalmic Suspension in the Treatment of Bacterial Conjunctivitis

Completed·BBausch & Lomb Incorporated·Phase 2/3·NCT00972777·474 enrolled

Concentration2 trials

Concentration of Besifloxacin, Gatifloxacin, and Moxifloxacin in Human Conjunctiva After Topical Instillation

Completed·BBausch & Lomb Incorporated·Phase 1·NCT00905762·119 enrolled

Assessment of the Concentrations of Besifloxacin, Moxifloxacin, or Gatifloxacin in the Aqueous Humor of Subjects

Completed·BBausch & Lomb Incorporated·Phase 1·NCT00824070·105 enrolled

Cataract2 trials

A Comparison of Prophylactic Antibacterial Efficacy of Besivance vs. VIGAMOX Prior to Cataract Surgery

Completed·BBucci Laser Vision Institute·Phase 4·NCT01296542·60 enrolled

Effect of Topical Besifloxacin on Ocular Surface Bacterial Microbiota Prior to Cataract Surgery

Completed·IInstituto de Oftalmología Fundación Conde de Valenciana·Phase 1·NCT04542759·60 enrolled

Absorption1 trial

Aqueous Absorption and Pharmacokinetics of Besivance Versus VIGAMOX in Patients Undergoing Phacoemulsification

Completed·FFrank A. Bucci, Jr., M.D.·Phase 4·NCT01296191·120 enrolled

Keratitis1 trial

Besifloxacin in Bacterial Keratitis

Completed·MMcGill University Health Centre/Research Institute of the McGill University Health Centre·N/A·NCT02497365·32 enrolled

Regulatory

FDA Approval Timeline[4]

May 28, 2009

BESIVANCE

NDA NDA022308

Sources

References

[1]
ClinicalTrials.gov — 9 trial records for Besifloxacin. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Besifloxacin compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Besifloxacin. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA022308). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Besivance. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Bausch Health Americas, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: BBausch Health Americas, Inc.

Patent Landscape[5]

Patent Cliff

Nov 13, 2029

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8937062Nov 13, 2029

8604020Mar 12, 2030

8415342Nov 7, 2030

8481526Jan 9, 2031

Besivance

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Bacterial Conjunctivitis3 trials

Concentration2 trials

Cataract2 trials

Absorption1 trial

Keratitis1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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