Reviews Supplements BESIVANCE® : Page 1

BESIFLOXACIN TECHNICAL PAPER 1 BESIVANCE ® (besifloxacin ophthalmic suspension) 0.6%: In Vitro Potency and Broad-spectrum Activity for the Treatment of Bacterial Conjunctivitis ABSTRACT Bacterial conjunctivitis is a common ocular infection that, although usually self-limited, can result in severe cases and develop vision-threatening complications. Diagnosis of bacterial conjunctivitis is generally clinical, and most cases can be managed with empirical antibiotic therapy. Use of a potent, broad-spectrum topical antibiotic is important for treatment. BESIVANCE ® (besifloxacin ophthalmic suspension) 0.6%, a fluoroquinolone developed specifically for topical ocular use and approved for the treatment of bacterial conjunctivitis, provides such an antibiotic choice. As a dual-halogenated topical chlorofluoroquinolone, besifloxacin demonstrates potent in vitro activity against a range of important ocular pathogens, including strains of methicillin-resistant staphylococci, and susceptible isolates of Pseudomonas aeruginosa . Formulated in a mucoadhesive vehicle, BESIVANCE ® also has excellent ocular surface residence time, making it a good choice for the treatment of bacterial conjunctivitis. Ron Melton, OD, FAAO Bacterial conjunctivitis is a common ocular surface infection. In the US, the incidence of bacterial conjunctivitis is estimated at about 1.3%. 1 Typically, bacterial conjunctivitis is acute and self-limited and can resolve spontaneously, but topical antibiotic therapy offers a number of benefits. 2,3 Antibiotic treatment can shorten the course of the disease, and speed the resolution of symptoms and infections. 2 Spectrum of In Vitro Activity and Potency The organisms that most often cause bacterial conjunctivitis include Haemo-philus influenzae , Streptococcus pneumoniae , Staphylococcus aureus , and Staphylococcus epidermidis . 4 Among these, S aureus is typically the most aggressive organism, and the combination of virulence and drug resistance makes methicillin-resistant S aureus (MRSA) an organism of great concern. Although MRSA has moved out into the community, healthcare workers remain at high risk of MRSA colonization because of its prevalence in hospital settings. 5 When confronted by a case of bacterial conjunctivitis, the gold standard for determining the causative pathogen is to culture the conjunctiva. Routine culture of every case of conjunctivitis is impractical in general practice settings, however, and patients with bacterial conjunctivitis diagnosed from signs and symptoms are typically treated empirically with topical ophthalmic antibiotics. To achieve bacterial eradication with empirical therapy, it is important to choose an agent with a wide spectrum of in vitro antimicrobial activity. A Powerful Fluoroquinolone Current generation fluoroquinolones are the antimicrobial agents most often used to treat bacterial conjunctivitis, in large part because they have a broad spectrum of in vitro activity. Despite the overall effectiveness of the class, fluoroquinolone Sponsored by Bausch + Lomb The clinical signficance of in vitro activity has not been established. See Important Safety Information about BESIVANCE ® . Indication BESIVANCE ® 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. Important Safety Information for BESIVANCE ® 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 non-susceptible 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 conjunctival redness. Other adverse events reported in patients receiving BESIVANCE ® occurring 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 see the prescribing information for BESIVANCE® on page 4.

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