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FOR RELEASE 5/29/2009, Friday

Bausch & Lomb Receives FDA Approval of Besivance™, New Topical Ophthalmic Antibacterial for the Treatment of Bacterial Conjunctivitis (“Pink Eye”)


Besivance Adds to Bausch & Lomb’s Expanding Ocular Pharmaceuticals Portfolio and Offers New Therapeutic Option for a Wide Range of Ocular Bacterial Pathogens1

MADISON, N.J. – Bausch & Lomb, a world leader in eye health, today announced that the U.S. Food and Drug Administration (FDA) approved Besivance™ (besifloxacin ophthalmic suspension) 0.6% for the treatment of bacterial conjunctivitis, commonly referred to as “pink eye.”  Besivance™ is a new topical ophthalmic antibacterial, administered via sterile ophthalmic drops, that treats a wide range of eye pathogens including those that most commonly cause bacterial conjunctivitis.4  Bacterial conjunctivitis is one of the most common ocular conditions worldwide.2

In December 2008, an FDA Advisory Committee voted unanimously to recommend approval of Besivance.

Besivance is the first fluoroquinolone specifically developed for ophthalmic use and is the first and only ophthalmic fluoroquinolone with no previous systemic use.  It offers broad-spectrum antibacterial activity, including activity against the strains that are the most common causes of bacterial conjunctivitis.3

"Topical ophthalmic besifloxacin offers physicians the opportunity to provide patients with an anti-infective that treats a broad range of bacterial ocular pathogens,” said Marguerite McDonald, MD, FACS, Clinical Professor of Ophthalmology at NYU School of Medicine, New York, New York.

The FDA approval of Besivance was based on a series of eight clinical trials.  These studies were designed to test the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics with the topical antibacterial.  Its efficacy was evaluated in three multi-center, randomized, double-masked 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.4

“Today’s FDA approval of Besivance provides patients with an advanced therapy that can eradicate bacterial conjunctivitis at its source both safely and effectively,” said Flemming Ornskov, M.D., M.P.H., corporate vice president and global president, Pharmaceuticals, Bausch & Lomb.  “At Bausch & Lomb we are committed to developing innovative eye health products that help enhance patients’ overall quality of life, and we are pleased to offer the medical community a new treatment option for this exceedingly common condition.”

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.


About Bacterial Conjunctivitis

Conjunctivitis is one of the most common eye diseases seen worldwide.2  Often referred to as “pink eye,” bacterial conjunctivitis is an infection of the conjunctiva, the outer-most layer of the eye that covers the white part of the eye.5  This contagious disease occurs in patients of all ages.  Typical signs include a red eye and discharge that persists throughout the day.6  The acute form of contagious conjunctivitis is most frequently seen in infants, schoolchildren and the elderly, generally as a result of bacterial or viral infections.2  Acute red eyes, most frequently diagnosed as acute bacterial conjunctivitis, account for 1 to 4 percent of all physician visits in the developed world.2

 

About Besivance

Besivance (besifloxacin ophthalmic suspension) 0.6%, is indicated for the treatment of bacterial conjunctivitis in patients one year and older, 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.

Besivance is for topical ophthalmic use only, and should not be injected subconjunctivally or directly into the anterior chamber of the eye.4  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.4 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.4  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.4  The safety and effectiveness of Besivance in infants below one year of age has not been established.4

Please see full prescribing information for Besivance at: www.besivance.com.

 

About Bausch & Lomb

Bausch & Lomb is the eye health company dedicated to perfecting vision and enhancing life for people around the world. Its core businesses include contact lenses and lens care products, ophthalmic surgical devices and instruments, and ophthalmic pharmaceuticals.  The Bausch & Lomb name is one of the best-known and most respected healthcare brands in the world. Founded in 1853, the company is headquartered in Rochester, N.Y., and employs more than 10,000 people worldwide.  Its products are available in more than 100 countries. More information is available at www.bausch.com.

 

About Pfizer Ophthalmics

Pfizer Ophthalmics, part of Pfizer’s Specialty Care business unit, is committed to preserving sight and eliminating preventable blindness and expanding its portfolio through licensing and partnerships.  Pfizer Ophthalmics discovers, develops and provides leading treatments in ophthalmology to support patients who are at risk of blindness or suffering from vision impairment, and to serve the health care professionals who treat them.

 

# # #

1.       Cavuoto K, Zutshi D, Karp CL, et al. Update on bacterial conjunctivitis in South Florida.
          Ophthalmology 2008;115:51-6.

2.       Hovding G. Acute bacterial conjunctivitis. Acta Ophthalmol 2008;86:5-17.

3.       Karpecki, P, DePaolis, M, Hunter, J, et al. Besifloxacin Opthalmic Suspension 0.6%  in Patients with
          Bacterial Conjuntivitis: A Multicenter, Prospective, Randomized, Double-Masked, Vehicle-Controlled,
          5-Day Efficacy and Safety Study.  Clinical Therapeutics 2009: 31:3-11

4.       Besivance™ Prescribing Information

5.       MedicineNet.com, Facts About “Pink Eye”. Available at
          http://www.medicinenet.com/script/main/art.asp?articlekey=41786.  Accessed 3/26/2009.

6.       Tarabishy, A, Jeng, B. Bacterial Conjunctivitis: A Review for Internists. Cleveland Clinical Journal of
          Medicine. 2008:  75:7-507.

 

* Besivance™ is a trademark of Bausch & Lomb, Inc.