1. ImportantSafetyInformationaboutBESIVANCE®
(cont.)
• Aswithotheranti-infectives,prolongeduseofBESIVANCE®
mayresultinovergrowth
ofnon-susceptibleorganisms,includingfungi.Ifsuper-infectionoccurs,discontinue
useandinstitutealternativetherapy.
• Patientsshouldnotwearcontactlensesiftheyhavesignsorsymptomsofbacterial
conjunctivitisorduringthecourseoftherapywithBESIVANCE®
.
• Themostcommonadverseeventreportedin2%ofpatientstreatedwithBESIVANCE®
wasconjunctivalredness.Otheradverseeventsreportedinpatientsreceiving
BESIVANCE®
occurringinapproximately1-2%ofpatientsincluded:blurredvision,eye
pain,eyeirritation,eyepruritusandheadache.
PleaseseeadditionalImportantSafetyInformationon
backandfullPrescribingInformationinpocket.
Concentration,µg/mL
10
100
610
173242
84.7
46.4
10.6
147
0.5
1
4
04812
0.25
0.125
0.06
Time,h
1000
MIC90forS.epidermidis
MIC90forS.aureus
MIC90forS.pneumoniae
MIC90forH.influenzae
MIC90forP.aeruginosa,MRSA-CR,andMRSE-CR
Conjunctiva
Druglayer
• Activemoleculesresideontheocularsurface
toprovideantibioticcoveragelastingupto
12hours.2,6
• BESIVANCE®
demonstratesbothinvitro
antimicrobialpotencyandlong-lastingtear
concentrations.2,7,8
BESIVANCE®
usesDuraSitetechnologydesignedtoadhere
totheocularsurfacetofightpathogens2,6-8
MIC=minimuminhibitoryconcentration;
MRSA-CR=ciprofloxacin-resistantMRSA;MRSE-CR=ciprofloxacin-resistantMRSE.
Clinicalsignificanceoftheseinvitrodatahasnotbeenestablished.
Invitrostudiesdemonstratedcross-resistancebetweenBESIVANCE®
andsomefluoroquinolones.Invitroresistanceto
BESIVANCE®
developsviamultiple-stepmutationsandoccursatageneralfrequencyof<3.3x10-10
forS.aureusand
<7x10-10
forS.pneumoniae.5
AllMIC90
valuesfordepictedorganismswerecollectedfromtheBESIVANCE®
clinicaldevelopmentprogram.
Studydesign:BESIVANCE®
wasadministeredasatopicalocularinstillationtohumansubjectsaspartofasingle-center,
open-labelstudy(N=64).Atpredeterminedintervalsafterdosing,oculartearsampleswerecollectedandanalyzedfor
besifloxacinlevels.2
AgainstPathogensofConcern
BESIVANCE®
tearconcentrationsupto
12hoursweregreaterthantheMIC90
forboth
commonandmoreresistantpathogens2-4
Data reported through 2015 in this open, ongoing study.
JAMA OPHTHALMOLOGY
ARMOR Surveillance Study 2015
OBJECTIVE:
To report resistance rates and trends among common ocular isolates collected
during the first 5 years of the ARMOR study.
STUDY DESIGN:
Ongoing, prospective, multicenter study designed to monitor antibiotic resistance
trends among isolates of 5 common ocular bacterial pathogens.
• 72 ocular centers, university hospitals, and community hospitals across
36 states collected isolates January 1, 2009, through December 31, 2013
• Analysis performed at an independent central laboratory from January 16 to
May 15, 2015
MAIN OUTCOMES AND MEASURES:
Minimum inhibitory concentrations for various antibiotic classes were interpreted
as susceptible, intermediate, or resistant based on established break points.
• 3237 isolates were collected from the conjunctiva, cornea, aqueous humor, and
vitreous humor. 3237 isolates were collected; the anatomical source was known
for 1280 isolates.
RELEVANCE:
Continued surveillance of ocular isolates provides important information
for ophthalmologists and optometrists to consider when selecting topical
antibacterials for empirical therapy.
Antibiotic Resistance Among Ocular
Pathogens in the United States
Five-Year Results From the Antibiotic Resistance Monitoring
in Ocular Microorganisms (ARMOR) Surveillance Study
Asbell PA, Sanfilippo CM, Pillar CM, DeCory HH, Sahm DF, Morris TW.
Indication
BESIVANCE®
(besifloxacin ophthalmic suspension) 0.6% is a quinolone antimicrobial indicated for
the treatment of bacterial conjunctivitis caused by susceptible isolates of the following bacteria:
Aerococcus viridans*, CDC coryneform group G, Corynebacterium pseudodiphtheriticum*,
Corynebacterium striatum*, Haemophilus influenzae, Moraxella catarrhalis*, Moraxella
lacunata*, Pseudomonas aeruginosa*, Staphylococcus aureus, Staphylococcus epidermidis,
Staphylococcus hominis*, Staphylococcus lugdunensis*, Staphylococcus warneri*, Streptococcus
mitis group, Streptococcus oralis, Streptococcus pneumoniae, Streptococcus salivarius*
*Efficacy for this organism was studied in fewer than 10 infections.
Important Safety Information about BESIVANCE®
(cont.)
• BESIVANCE®
is not intended to be administered systemically. Quinolones administered
systemically have been associated with hypersensitivity reactions, even following a single
dose. Patients should be advised to discontinue use immediately and contact their physician
at the first sign of a rash or allergic reaction.
• Safety and effectiveness in infants below one year of age have not been established.
Please see additional Important Safety Information inside and full Prescribing Information in pocket.
*Clinical significance of these in vitro data has not been established.
References: 1. Asbell PA, Sanfilippo CM, Pillar CM, DeCory HH, Sahm DF, Morris TW. Antibiotic Resistance Among Ocular Pathogens in the United
States: Five-Year Results From the Antibiotic Resistance Monitoring in Ocular Microorganisms (ARMOR) Surveillance Study. JAMA Ophthalmol.
2015;133(12):1445-1454. 2. Proksch JW, Granvil CP, Siou-Mermet R, Comstock TL, Paterno MR, Ward KW. Ocular pharmacokinetics of besifloxacin
following topical administration to rabbits, monkeys, and humans. J Ocul Pharmacol Ther. 2009;25(4):335-344. 3. Data on file. Bausch Lomb
Incorporated. 4. Haas W, Gearinger LS, Usner DW, DeCory HH, Morris TW. Integrated analysis of three bacterial conjunctivitis trials of besifloxacin
ophthalmic suspension, 0.6%: etiology of bacterial conjunctivitis and antibacterial susceptibility profile. Clin Ophthalmol. 2011;5:1369-1379.
5. BESIVANCE®
Prescribing Information, September 2012. 6. DuraSite mechanism of action. InSite Vision Inc website. Accessed May 24, 2016.
7. Comstock TL, Morris TW, Gearinger LS, DeCory HH. Clinical outcomes with besifloxacin ophthalmic suspension 0.6% in the treatment of bacterial
conjunctivitis due to potentially consequential pathogens. Clin Optom. 2014;6:25-35. 8. Tepedino ME, Heller WH, Usner DW, et al. Phase III efficacy
and safety study of besifloxacin ophthalmic suspension 0.6% in the treatment of bacterial conjunctivitis. Curr Med Res Opin. 2009;25(5):1159-1169.
Besivance is a trademark of Bausch Lomb Incorporated or its affiliates.
© Bausch Lomb Incorporated. All rights reserved. BES.0080.USA.16
Experience the Broad-Spectrum Coverage
of BESIVANCE®1,5
• The only dual-halogenated chlorofluoroquinolone that provides potent inhibition of
bacterial DNA replication.5
*
• Demonstrated potent in vitro inhibitory activity against common ocular pathogens
tracked in the ARMOR surveillance study, as shown by low MIC90
values.1
*
• Provides long-lasting tear concentrations.2,3
• Flexible TID dosing that allows for up to 12 hours between doses for 7-day treatment.5
• Indicated to treat bacterial conjunctivitis caused by gram+ and gram- pathogens,
including5
:
»» Gram+: S. aureus (MRSA/MRSE), S. epidermidis, S. pneumoniae
»» Gram-: H. influenzae and P. aeruginosa
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patients save on BESIVANCE®

2. Important Safety Information about BESIVANCE®
• BESIVANCE®
is for topical ophthalmic use only, and should not be injected
subconjunctivally, nor should it be introduced directly into the anterior chamber of the eye.
Indication
BESIVANCE®
(besifloxacin ophthalmic suspension) 0.6% is a quinolone antimicrobial indicated for
the treatment of bacterial conjunctivitis caused by susceptible isolates of the following bacteria:
Aerococcus viridans*, CDC coryneform group G, Corynebacterium pseudodiphtheriticum*,
Corynebacterium striatum*, Haemophilus influenzae, Moraxella catarrhalis*, Moraxella
lacunata*, Pseudomonas aeruginosa*, Staphylococcus aureus, Staphylococcus epidermidis,
Staphylococcus hominis*, Staphylococcus lugdunensis*, Staphylococcus warneri*, Streptococcus
mitis group, Streptococcus oralis, Streptococcus pneumoniae, Streptococcus salivarius*
*Efficacy for this organism was studied in fewer than 10 infections.
Besifloxacin showed potent in vitro inhibitory activity against
common and difficult-to-treat ocular pathogens tracked in
the ARMOR study, as demonstrated by low MIC90
values1
Pathogen (% of total isolates) gram +/- Besifloxacin MIC90
(ug/mL)
Staphylococcus aureus
36% (1169/3237)
- MSSA: 58% (676/1169)
- MRSA: 42% (493/1169)
gram+
MSSA: 0.25
MRSA: 2
Coagulase-negative
Staphylococcus
31% (992/3237)
- MSCoNS: 50% (499/992)
- MRCoNS: 50% (493/992)
gram+
MSCoNS: 0.25
MRCoNS: 4
Streptococcus
pneumoniae
10% (330/3237)
gram+ 0.06
Pseudomonas
aeruginosa
12% (389/3237)
gram- 4
Haemophilus influenzae
11% (357/3237)
gram- ≤0.06
Clinical significance of these in vitro data has not been established.
MSSA=methicillin-sensitive Staphylococcus aureus; MRSA=methicillin-resistant Staphylococcus aureus;
MRCoNS=methicillin-resistant coagulase-negative staphylococci; MSCoNS=methicillin-susceptible coagulase-negative staphylococci.
MIC90
=minimum inhibitory concentration 90%. MICs expressed in µg/mL.
ARMOR Study
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