Sustained drug delivery increases residence time on the ocular surface1,2
Flexible dosing, from 4 to 12 hours apart1,4
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 MIC90 values for P aeruginosa, S aureus, S pneumoniae, MRSE, MRSA, MSCoNS, MRCoNS, and H influenzae are from the ARMOR 2015 surveillance study.5 MIC90 values for S epidermidis are from the BESIVANCE clinical development program.6 Clinical significance of these in vitro data has not been established.
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. Mah FS, Sanfilippo SM. Besifloxacin: efficacy and safety in treatment and prevention of ocular bacterial infections. Ophthalmol Ther. 2016;5(1):1-20. doi:10.1007/s40123-016-0046-6 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. doi:10.1089/jop.2008.0116 3. Agrahari V, Mandal A, Agrahari V, et al. A comprehensive insight on ocular pharmacokinetics. Drug Deliv Transl Res. 2016;6(6):735-754. doi:10.1007/s13346-016-0339-2 4. BESIVANCE Prescribing information. Bausch & Lomb Incorporated; Rev. 2020. 5. Asbell PA, Sanfilippo CM, Pillar CM, DeCory H, 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. doi:10.1001/jamaophthalmol.2015.3888 6. 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.
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