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FOR RELEASE 9/19/2012, Wednesday

Besivance® (besifloxacin ophthalmic suspension) 0.6% Receives Additional Indications, Including the Treatment of Bacterial Conjunctivitis Infections Due to Pseudomonas aeruginosa

MADISON, NJ - Bausch + Lomb, the global eye health company, today announced that the U.S. Food and Drug Administration (FDA) has granted additional labeling indications for its Besivance® (besifloxacin ophthalmic suspension) 0.6 percent eye drop, including an indication to treat bacterial conjunctivitis infections caused by susceptible isolates of Pseudomonas aeruginosa*, a rare but potentially virulent pathogen that can be associated with serious eye conditions, such as corneal ulcers and blindness. Three other significant ocular pathogens added to the indications granted for the Besivance eye drop include Aerococcus viridans*, Moraxella catarrhalis* and Staphylococcus warneri*.

Besivance suspension has been approved in the U.S. for the treatment of bacterial conjunctivitis since 2009 and is the first and only dual-halogenated chlorofluoroquinolone in topical ophthalmic use. It has demonstrated potent activity and high rates of eradication against problematic multi-drug resistant Gram positive organisms, such as methicillin-resistant Staphylococcus aureus (MRSA) / methicillin-resistant Staphylococcus epidermidis (MRSE), and Gram negative pathogens, such as Pseudomonas aeruginosa, that can cause serious eye infections.1,2
 
“Many eye care physicians consider Pseudomonas aeruginosa as a more serious threat to ocular health than MRSA,” said professor Terrence P. O’Brien, M.D., with the Bascom Palmer Eye Institute of the University of Miami, FL. “With the additional indication of Pseudomonas aeruginosa as well as the other important ocular pathogens covered by besifloxacin 0.6 percent (Besivance), physicians now have a potent, broad spectrum, branded prescription eye drop to rapidly treat bacterial conjunctivitis caused by the most common serious sight-threatening pathogens.”

Pseudomonas aeruginosa is a big concern for all eye care providers due to its rapid onset and potentially severe outcomes,” said Paul M. Karpecki, O.D., FAAO with the Koffler Vision Group in Lexington, KY.  “Contact lens users who over-wear or take improper care of their lens are at higher risk for this infection, as are patients who are immune-compromised with afflictions such as diabetes, cancer or AIDS. Physicians have to be vigilant in identifying and treating bacterial conjunctivitis infections due to Pseudomonas aeruginosa. This additional indication for Besivance gives eye care professionals a new treatment option to prevent Pseudomonas aeruginosa from causing vision loss.”

About Besivance
Besivance (besifloxacin ophthalmic suspension) 0.6 percent is  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, and Streptococcus salivarius.

*Efficacy for this organism was studied in fewer than 10 infections.

Dosage and Administration
Instill one drop into the affected eye(s) three times a day, four to 12 hours apart for seven days.

Dosage Forms and Strengths
Topical ophthalmic suspension:  besifloxacin ophthalmic suspension, 0.6 percent.

Important Risk Information about 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 report in two percent of patients treated with Besivance   was conjunctival redness.  Other adverse events reported in patients receiving Besivance   occurring in approximately one-two percent 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.

About Bausch + Lomb
Bausch + Lomb is one of the best-known and most respected healthcare companies in the world. Its core businesses include contact lenses and lens care products, ophthalmic surgical devices and instruments, and ophthalmic pharmaceuticals. Founded in 1853, the company is headquartered in Rochester, NY, and employs roughly 11,000 people worldwide. Its products are available in more than 100 countries. More information is available at www.bausch.com.

References
1.  Haas W, Pillar CM, Torres M, Morris TM, Sahm DF. Monitoring antibiotic resistance in ocular microorganisms: results from the Antibiotic Resistance Monitoring in Ocular MicRorganisms (ARMOR) 2009 surveillance study. Am J Ophthalmol. 2011; 152 (4): 567-574 e3. 
2.  Fleiszig SM, Evans DJ. The pathogenesis of bacterial keratitis: studies with Pseudomonas aeruginosa. Clin Exp Optom. 2002;85:271–278.

Besivance® is a registered trademark of Bausch & Lomb Incorporated or its affiliates.
© 2012 Bausch & Lomb Incorporated.

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News Media Contacts:
Jeanie Herbert
Global Surgical Communications, Bausch + Lomb
(949) 521-7948, (714) 325-3584 (mobile) or jeanie.herbert@bausch.com

Elizabeth Murphy
Global Communications, Bausch + Lomb
(585) 338-8528 or elizabeth.murphy@bausch.com

Tad Heitmann
BioComm Network on behalf of Bausch + Lomb
(714) 273-2937 or theitmann@BioCommNetwork.com