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Besivance (besifloxacin ophthalmic suspension) 0.6%

besivance

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.

The FDA approval of Besivance was based on a series of 8 clinical trials designed to test efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics. It's efficacy was evaluated in 3 multi-center, randomized, double-masked clinical trials involving nearly 2,400 patients with a clinical diagnosis of bacterial conjunctivitis. In clinical trials, investigators found that Besivance treatment resulted in a greater proportion of patients experiencing clinical resolution and microbial eradication, when compared to its vehicle.1

  • In a randomized, double-masked, multicenter clinical trial, in which patients 1 to 98 years of age were dosed 3 times a day for 5 days, Besivance was superior to its vehicle in patients with bacterial conjunctivitis.

  • Clinical resolution was achieved in 45 percent (90/198) of patients for the Besivance treated group versus 33 percent (63/191) of patients in the vehicle-treated group.

  • The trial demonstrated a statistically significant difference in the bacterial pathogen eradication rates - 91 percent (181/198) for the Besivance treated group versus 60 percent (114/191) for the vehicle treated group.

  • Microbiological eradication does not always correlate with clinical outcome in anti-infective trials.

Important Risk Information

  • Besivance is for topical ophthalmic use only, and should not be injected subconjunctivally, nor should it be introduced directly into the anterior chamber of the eye.
  • As with other anti-infectives, prolonged use of Besivance may result in overgrowth of nonsusceptible 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 2% of patients treated with Besivance was conjuntival redness. Other adverse events reported in patients receiving Besivance occuring in approximately 1-2% of patients included: blurred vision, eye pain, eye irritation, eye pruritus and headache.
  • Besivance is not intended to be administered systemically. Quinolones administered systemically have been associated with hypersensitivity reactions, even following a single dose. Patients should be advised to discontinue use immediately and contact their physician at the first sign of a rash or allergic reaction. 
  • Safety and effectiveness in infants below one year of age have not been established.

Please click here (214.8 KB, PDF)to view the Besivance full Prescribing Information.

1. Besivance Prescribing Information. April 2009.

US/LGX/12/0052(1)