Rx Pharmaceuticals

Besivance™ (besifloxacin ophthalmic suspension) 0.6% is a topical ophthalmic antibacterial indicated for the treatment of bacterial conjunctivitis caused by susceptible isolates of the following bacteria: CDC coryneform group G, 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.

* The asterisk denotes efficacy for these organisms was tested 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 Safety Information

Besivance is for topical ophthalmic use only, and should not be injected subconjunctivally or directly into the anterior chamber of the eye.¹  As with other anti-infectives, prolonged use of Besivance may result in overgrowth of non-susceptible organisms, including fungi.  If superinfection 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.

Although 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.

The most frequently reported adverse event in clinical studies was conjunctival redness, reported in approximately 2% of patients. Other adverse events reported in approximately 1-2% of patients included blurred vision, eye pain, eye irritation, eye pruritus and headache.

The safety and effectiveness of Besivance in infants below one year of age has not been established.

Please see full prescribing information for Besivance.

Besivance will be available by prescription in U.S. pharmacies in the second quarter of 2009.   Besivance will be promoted by both the Bausch & Lomb and Pfizer, Inc. sales forces.

Visit www.besivance.com to learn more.

 

1. Besivance™ Prescribing Information. April 2009.