bromfenac

april 2013

Bausch + Lomb, the global eye health company, today announced that the U.S. Food and Drug Administration (FDA) has approved the company’s New Drug Application (NDA) for Prolensa (bromfenac ophthalmic solution) 0.07 percent prescription eye drop, an innovative once-daily nonsteroidal anti-inflammatory drug (NSAID) for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery. Prolensa will be available in 1.6ml and 3ml bottle sizes.

Prolensa provides powerful and rapid resolution of inflammation and pain by leveraging the unique potency of the bromfenac molecule in a formulation designed to facilitate ocular penetration. The advanced formulation allows for a lower concentration of bromfenac in a once daily dosing regimen. Prolensa is a solution that does not require shaking to deliver a consistent dose in each drop.

“The data show that once-daily dosing with Prolensa provides powerful and rapid control of inflammation and pain following cataract surgery, confirming the potency of this NSAID and the benefits of the new formulation,” said Steven M. Silverstein, M.D., FACS, founder of Silverstein Eye Centers in Kansas City, MO. “Prolensa reduces the amount of medication placed on the healing eye while maintaining a high degree of efficacy and ocular comfort.”

The efficacy of Prolensa was evaluated in two randomized, double-masked, vehicle-controlled studies of patients undergoing cataract surgery. Each randomized patient received Prolensa or vehicle starting with one drop into the surgical eye on the day prior to and the day of surgery, and for 14 days following surgery. The primary efficacy endpoint was complete clearing of ocular inflammation (assessed by the summed ocular inflammation score, SOIS, which includes cells and flare) by day 15. The secondary efficacy endpoint was the number of subjects that were pain free on day one after surgery.

About Bausch + Lomb

Bausch + Lomb is a leading global eye health company that is solely focused on protecting, enhancing, and restoring people’s eyesight. Our core businesses include ophthalmic pharmaceuticals, contact lenses and lens care products, and ophthalmic surgical devices and instruments. We globally develop, manufacture and market one of the most comprehensive product portfolios in our industry, which are available in more than 100 countries. Founded in 1853, our company is headquartered in Rochester, NY, and employs more than 11,000 people worldwide.

Prolensa™ is a trademark of Bausch & Lomb Incorporated or its affiliates.

Bromfenac is a non-steroidal anti-inflammatory drug (NSAID) marketed in the US as an ophthalmic solution (current brand name Bromday, prior formulation brand name Xibrom, which has since been discontinued.) by ISTA Pharmaceuticals for short-term, local use. Bromday® is the once-daily formulation of bromfenac, while Xibrom®, which has since been discontinued, was the twice-daily formulation. Bromfenac is indicated for the treatment of ocular inflammation and pain after cataract surgery, though it may be prescribed in an off-label manner by the physician.

For ophthalmic use, bromfenac has been prescribed more than 20,000,000 times across the world. As an eye drop, it has been available since 2000, starting in Japan where it was sold as Bronuck®. It was first FDA approved for use in the United States in 2005 and it was marketed as Xibrom®, twice-daily. October 2010 was the FDA approval of the new once-daily formulation of bromfenac called Bromday®. The bromfenac molecule will be marketed in Europe and other worldwide markets with agreements from Bausch & Lomb, Croma Pharma, and other companies.

Bromfenac was formerly marketed in the United States by Wyeth-Ayerst in an oral formulation called Duract® for short-term relief of pain (less than 10 days at a time). It was brought to market in July, 1997, and was withdrawn June 22, 1998 following numerous reports of hepatotoxicity in patients who had taken the medication for longer than the recommended 10-day period. The dose was one 25 mg capsule every 6 to 8 hours, or two capsules if taken with a high-fat meal, up to a maximum of 150 mg per day.