Home»Clinical Data»Long-lasting Tear Concentrations

BESIVANCE Demonstrates Long-lasting Tear Concentrations1,2

BESIVANCE is formulated with DuraSite technology, which allows the medication to remain on the ocular surface to fight bacterial pathogens.2,3 This allows for flexible dosing with BESIVANCE. Doses can be instilled 4 to 12 hours apart.1

Chart of tear concentrations over 12 hours: Besifloxacin tear concentrations over 12 hours were greater than the MIC for both susceptible and resistant bacterial pathogens
Chart of tear concentrations over 12 hours: Besifloxacin tear concentrations over 12 hours were greater than the MIC for both susceptible and resistant bacterial pathogens

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.5 MIC90 values for P. aeruginosa, S. aureus, S. pneumoniae, MRSE, MRSA, MSCoNS, MRCoNS, and H. influenzae are from the ARMOR 2015 surveillance study. MIC90 values for S. epidermidis are from the BESIVANCE clinical development program.

*MRSA-CR = ciprofloxacin-resistant MRSA; MRSE-CR = ciprofloxacin-resistant MRSE.

Clinical significance of these in vitro data has not been established.

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Learn about the in vitro inhibitory activity of besifloxacin against ocular bacterial pathogens.

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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.

Click here for full Prescribing Information for BESIVANCE.

References: 1. BESIVANCE [package insert]. Tampa, FL: Bausch & Lomb Incorporated; 2018. 2. Data on file. Bausch & Lomb Incorporated. 3. DuraSite mechanism of action. InSite Vision Incorporated website. http://www.insitevision.com/durasite_moa.html. Accessed October 18, 2017. 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. 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. 6. 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.

 
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.

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