Bausch & Lomb Receives FDA Approval of Besivance(TM), New Topical Ophthalmic Antibacterial for the Treatment of Bacterial Conjunctivitis ('... (

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

Date:5/29/2009

- Besivance Adds to Bausch & Lomb's Expanding Ocular Pharmaceuticals Portfolio and Offers New Therapeutic Option for a Wide Range of Ocular Bacterial Pathogens(1) -

MADISON, N.J., May 29 /PRNewswire/ -- Bausch & Lomb, a world leader in eye health, today announced that the U.S. Food and Drug Administration (FDA) approved Besivance(TM) (besifloxacin ophthalmic suspension) 0.6% for the treatment of bacterial conjunctivitis, commonly referred to as "pink eye." Besivance(TM) 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. I
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Bausch & Lomb Receives FDA Approval of Besivance(TM), New Topical Ophthalmic Antibacterial for the Treatment of Bacterial Conjunctivitis ('...( - Besivance Adds to Bausch & Lomb...),Health