Important Safety Information about BESIVANCE® (cont.)• As with other anti-infectives, prolonged use of BESIVANCE

® may result in overgrowth

of non-susceptible organisms, including fungi. If super-infection occurs, discontinue use and institute alternative therapy.

• Patients should not wear contact lenses if they have signs or symptoms of bacterial conjunctivitis or during the course of therapy with BESIVANCE

®.

• The most common adverse event reported in 2% of patients treated with BESIVANCE®

was conjunctival redness. Other adverse events reported in patients receiving BESIVANCE

® occurring in approximately 1-2% of patients included: blurred vision, eye

pain, eye irritation, eye pruritus and headache.

Please see additional Important Safety Information on back and full Prescribing Information in pocket.

Concentration, µg/m

L

10

100

610173242

84.746.4

10.6

147

0.51

4

04812

0.250.1250.06

Time, h

1000

MIC90 for S. epidermidisMIC90 for S. aureusMIC90 for S. pneumoniaeMIC90 for H. influenzae

MIC90 for P. aeruginosa, MRSA-CR, and MRSE-CR

Conjunctiva

Drug layer

• Active molecules reside on the ocular surface to provide antibiotic coverage lasting up to 12 hours.

2,6

• BESIVANCE® demonstrates both in vitro

antimicrobial potency and long-lasting tear concentrations.

2,7,8

BESIVANCE® uses DuraSite technology designed to adhere

to the ocular surface to fight pathogens2,6-8

MIC = minimum inhibitory concentration;MRSA-CR=ciprofloxacin-resistant MRSA; MRSE-CR=ciprofloxacin-resistant MRSE.

Clinical significance of these in vitro data has not been established.In vitro studies demonstrated cross-resistance between BESIVANCE

® and some fluoroquinolones. In vitro resistance to

BESIVANCE® develops via multiple-step mutations and occurs at a general frequency of <3.3 x 10

-10 for S. aureus and

<7 x 10-10

for S. pneumoniae.5

All MIC90 values for depicted organisms were collected from the BESIVANCE® clinical development program.

Study design: BESIVANCE® was administered as a topical ocular instillation to human subjects as part of a single-center,

open-label study (N=64). At predetermined intervals after dosing, ocular tear samples were collected and analyzed for besifloxacin levels.

2

Against Pathogens of Concern

BESIVANCE® tear concentrations up to

12 hours were greater than the MIC90 for both common and more resistant pathogens

2-4

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 StatesFive-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.

IndicationBESIVANCE® (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 MIC

90 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

Visit BauschAccessProgram.com to help patients save on BESIVANCE®

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.

IndicationBESIVANCE® (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 MIC

90 values1

Pathogen (% of total isolates) gram +/- Besifloxacin MIC90(ug/mL)

Staphylococcus aureus36% (1169/3237)- MSSA: 58% (676/1169)

- MRSA: 42% (493/1169)

gram+MSSA: 0.25MRSA: 2

Coagulase-negative Staphylococcus31% (992/3237)- MSCoNS: 50% (499/992)

- MRCoNS: 50% (493/992)

gram+MSCoNS: 0.25MRCoNS: 4

Streptococcus pneumoniae10% (330/3237)

gram+ 0.06

Pseudomonas aeruginosa12% (389/3237)

gram- 4

Haemophilus influenzae11% (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.MIC

90=minimum inhibitory concentration 90%. MICs expressed in µg/mL.

ARMOR Study

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