FDA grants B+L additional indications approval on Besivance®November 10, 2012
Bausch + Lomb announced that the U.S. Food and Drug Administration (FDA) has granted additional labeling indications for its Besivance® (besifloxacin ophthalmic suspension) 0.6 percent eyedrop, 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 eyedrop include Aerococcus viridians, Moraxella catarrhis and Staphylococcus warneri.
Besivance suspension has been approved in the United States 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 multidrug-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.
“Many eye care physicians consider Pseudomonas aeruginosa as a more serious threat to ocular health than MRSA,” said Prof. Terrence P. O’Brien, M.D., with the Bascom Palmer Eye Institute of the University of Miami in Florida.
“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., 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.”