B + L submits NDA for new formulation of bromfenac

Madison, NJ-Bausch + Lomb (B + L) has submitted a new drug application (NDA) to the FDA, seeking approval for a bromfenac ophthalmic solution (Prolensa) for the treatment of ocular inflammation and pain following cataract surgery.

The once-daily topical nonsteroidal anti-inflammatory drug (NSAID), developed by recently acquired ISTA Pharmaceuticals, incorporates a lower concentration of bromfenac than the currently available once-daily formulation (Bromday, which has a 0.09% concentration) in a new formulation.

“The new, optimized formulation used for [the solution] allows for a lower concentration of bromfenac while maintaining the convenience of once-daily use currently prescribed with [the existing formulation],” said Calvin Roberts, MD, executive vice president, chief medical officer, B + L.

The U.S. Patent and Trademark Office recently issued a patent, expiring in 2025, for the new product’s formulation and method of use to the licensor, Senju Pharmaceutical Co. Ltd.

“The [NDA] filing is an important step toward bringing safe, effective, and meaningful medical advances to medical professionals and their patients,” said Marvin Garrett, B + L’s vice president of U.S. regulatory affairs, quality assurance, and compliance. “It’s also a timely example of the progress we continue to make on critical [research and development] programs as we work to bring together the best of ISTA Pharmaceuticals and B + L.”

In May 2002, ISTA acquired U.S. ophthalmic rights to bromfenac under a license from Senju Pharmaceuticals Co. Ltd. From 2005 to 2011, ISTA marketed a twice-daily solution of bromfenac 0.09% (Xibrom) in the United States for the treatment of postoperative inflammation and the reduction of ocular pain in patients who have undergone cataract surgery. In October 2010, ISTA received FDA approval for the currently available once-daily formulation; the company discontinued shipments of the twice-daily formulation in February 2011. In June 2012, B + L acquired ISTA.

The current bromfenac solution is the only once-daily treatment option in the U.S. ophthalmic NSAID market.

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