IN A PEDIATRIC POPULATION, BESIFLOXACIN DEMONSTRATED in vitro INHIBITORY ACTIVITY AGAINST COMMON AND RESISTANT OCULAR BACTERIAL PATHOGENS1

The ARMOR study found that, in a significant number of isolates obtained from ocular infections in pediatric patients (≤17 years of age), besifloxacin, the active molecule in BESIVANCE, demonstrated the lowest MIC90 values of all ophthalmic antibiotics tested against S. aureus and CoNS, including MR isolates and S. pneumoniae. The ARMOR study measured the minimum inhibitory concentration (μg/mL) that inhibits the growth of 90% of indicated isolates (MIC90).1

AARMOR study results of antibiotic activity against ocular pathogens

Table only includes antibiotics that are available in topical ophthalmic products that have a bacterial conjunctivitis indication. Vancomycin was part of the ARMOR study, but is not indicated for bacterial conjunctivitis. The table is not intended to demonstrate clinical efficacy. Clinical significance of these in vitro data has not been established. Safety and effectiveness in infants below one year of age have not been established

*MSSA n=181; MRSA n = 62.

MSCoNS n=104; MRCoNS n=78.

n=122

§Polymyxin B is used in combination with trimethoprim for bacterial conjunctivitis.

NA = Not available

PEDIATRIC ARMOR DATA LIMITATIONS1:

  • The isolate collection was limited to US sites
  • There is potential for sampling biases as ocular pathogens are not routinely cultured in community-based practices. The pediatric isolate dataset analyzed here may be skewed toward more difficult cases and may not reflect resistance patterns in community-based practices

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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
  • BESIVANCE is not for injection into the eye.
  • 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 approximately 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.
  • Safety and effectiveness in infants below one year of age have not been established.

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References: 1. Alter SJ, Sanfilippo CM, Asbell PA, DeCory HH. Antibiotic resistance among pediatric-sourced ocular pathogens: 8-Year findings from the Antibiotic Resistance Monitoring in Ocular Microorganisms (ARMOR) surveillance study. Pediatr Infect Dis J. 2019;38(2):138-145. 2. Data on file. Bausch & Lomb Incorporated.

 
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
  • BESIVANCE is not for injection into the eye.
  • 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 approximately 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.
  • Safety and effectiveness in infants below one year of age have not been established.

Click here for full Prescribing Information for BESIVANCE.