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.
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1. Besivance Prescribing Information. April 2009.