Bausch & Lomb Receives FDA Approval of Besivance(TM), 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 Pathogens
Bausch & Lomb, a world leader in eye health, today announced June 4th 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. Bacterial conjunctivitis is one of the most common ocular conditions worldwide.
In December 2008, an FDA Advisory Committee voted unanimously to recommend approval of Besivance.† It is 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.
"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.
"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.
As yet no news is available on its availability in the UK
About Bacterial Conjunctivitis
Conjunctivitis is one of the most common eye diseases seen worldwide and is often referred to as "pink eye," bacterial conjunctivitis it is an infection of the conjunctiva, the outer-most layer of the eye that covers the white part of the eye. This contagious disease occurs in patients of all ages.
Typical signs include a red eye and discharge that persists throughout the day. 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. Acute red eyes, most frequently diagnosed as acute bacterial conjunctivitis, account for 1 to 4 percent of all physician visits in the developed world.