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.

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