General Information

Besivance is a fluoroquinolone antibacterial with activity against Gram-positive and Gram-negative bacteria due to the inhibition of both bacterial DNA gyrase and topoisomerase IV. DNA gyrase is an essential enzyme required for replication, transcription and repair of bacterial DNA. Topoisomerase IV is an essential enzyme required for partitioning of the chromosomal DNA during bacterial cell division. Besifloxacin is bactericidal with minimum bactericidal concentrations generally within one dilution of the minimum inhibitory concentrations.

Besivance is specifically indicated for the treatment of bacterial conjunctivitis caused by susceptible isolates of the following bacteria:

Corynebacterium pseudodiphtheriticum

Corynebacterium striatum Haemophilus influenzae

Moraxella lacunata

Staphylococcus aureus

Staphylococcus epidermidis

Staphylococcus hominis

Staphylococcus lugdunensis

Streptococcus mitis group

Streptococcus oralis

Streptococcus pneumoniae

Streptococcus salivarius

Besivance is supplied as a 7.5 mL bottle filled with 5 mL of besifloxacin ophthalmic suspension, 0.6%. The recommended initial dose is one drop in the affected eye(s) 3 times a day, four to twelve hours apart for 7 days.

Clinical Results

FDA Approval
The FDA approval of Besivance was based on the results of a single clinical trial. This randomized, double-masked, placebo controlled, multicenter study enrolled subjects with bacterial conjunctivitis, 1-98 years of age, who were dosed 3 times a day for 5 days with Besivance (n=198) or placebo (n=191). Besivance was superior to its placebo: clinical resolution was achieved in 45% of the Besivance treated group versus 33% of the placebo treated group (difference 12%, 95% CI 3% - 22%). Microbiological outcomes demonstrated a statistically significant eradication rate for causative pathogens of 91% for the Besivance treated group versus 60% for the placebo treated group (difference 31%, 95% CI 23% - 40%).

Side Effects

Adverse events associated with the use of Besivance may include, but are not limited to, the following:

• Conjunctival redness
• Blurred vision
• Eye pain
• Eye irritation
• Eye pruritus
• Headache

Mechanism of Action

Besivance is a fluoroquinolone antibacterial with activity against Gram-positive and Gram-negative bacteria due to the inhibition of both bacterial DNA gyrase and topoisomerase IV. DNA gyrase is an essential enzyme required for replication, transcription and repair of bacterial DNA. Topoisomerase IV is an essential enzyme required for partitioning of the chromosomal DNA during bacterial cell division. Besifloxacin is bactericidal with minimum bactericidal concentrations generally within one dilution of the minimum inhibitory concentrations.

Literature References

Karpecki P, Depaolis M, Hunter JA, White EM, Rigel L, Brunner LS, Usner DW, Paterno MR, Comstock TL Besifloxacin ophthalmic suspension 0.6% in patients with bacterial conjunctivitis: A multicenter, prospective, randomized, double-masked, vehicle-controlled, 5-day efficacy and safety study. Clinical Therapeutics 2009 Mar;31(3):514-26

Tepedino ME, Heller WH, Usner DW, Brunner LS, Morris TW, Haas W, Paterno MR, Comstock TL Phase III efficacy and safety study of besifloxacin ophthalmic suspension 0.6% in the treatment of bacterial conjunctivitis. Current Medical Research and Opinion 2009 May;25(5):1159-69

Ward KW, Lepage JF, Driot JY Nonclinical pharmacodynamics, pharmacokinetics, and safety of BOL-303224-A, a novel fluoroquinolone antimicrobial agent for topical ophthalmic use. Journal of Ocular Pharmacology and Therapeutics : the Official Journal of the Association for Ocular Pharmacology and Therapeutics 2007 Jun;23(3):243-56

Additional Information

For additional information regarding Besivance or bacterial conjunctivitis, please visit the Besivance web page.