FDA advisory committee recommends approval of anti-infective eye drop

January 20, 2009

The FDA Dermatologic and Ophthalmic Drugs Advisory Committee has unanimously voted to recommend approval of Bausch & Lomb's besifloxacin ophthalmic suspension 0.6%, according to prepared statements by Bausch & Lomb and InSite Vision.

Alameda, CA, and Rochester, NY

-The FDA Dermatologic and Ophthalmic Drugs Advisory Committee has unanimously voted to recommend approval of Bausch & Lomb’s besifloxacin ophthalmic suspension 0.6%, according to prepared statements by Bausch & Lomb and InSite Vision.

The anti-infective drop, developed specifically for ophthalmic use, will be used as a treatment for bacterial conjunctivitis.

“We are encouraged by this [recent] committee discussion and vote, and [we] look forward to continue working with the FDA to gain final approval,” said Flemming Ornskov, MD, MPH, corporate vice president and global president, Pharmaceuticals, Bausch & Lomb. “Our intent remains to bring this innovative product to market, beginning in the United States, in 2009.”

The drop incorporates a patented drug delivery system (DuraSite, InSite Vision) that allows for targeted and sustained administration, according to that company. The system is designed to increase the time that a therapeutic level of medication remains on the eye’s surface, enabling a less-frequent dosing schedule, an increased patient adherence rate, and increased efficacy.

The FDA recommendation is a key step in the approval review process for a new drug application (NDA), according to InSite Vision.

“This positive recommendation by the FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee further demonstrates the clinical value of the . . . technology in new products promising valuable approaches to treating common eye-care conditions,” said Louis Drapeau, InSite Vision’s chief executive officer. “This new . . . agent has the potential to be the second approved product incorporating our . . . platform. We continue to look for new opportunities to develop pharmaceutical products utilizing this novel technology platform.”

Bausch & Lomb licensed the besifloxacin drug delivery system formulation from InSite Vision in 2003 following phase I clinical studies and continued the development to this NDA filing, according to InSite Vision’s prepared statement.