B+L applies for FDA Prolensa drug approval

August 15, 2012

Bausch + Lomb, the global eye health company, announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for Prolensa™ (bromfenac ophthalmic solution), a once-daily topical nonsteroidal anti-inflammatory compound for the treatment of ocular inflammation and pain following cataract surgery.

Prolensa, developed by recently acquired ISTA Pharmaceuticals, Inc., incorporates a lower concentration of bromfenac than the currently available once-daily Bromday™ (bromfenac ophthalmic solution) 0.09%, in a new formulation.

“The new, optimized formulation used for Prolensa allows for a lower concentration of bromfenac, while maintaining the convenience of once-daily use currently prescribed with Bromday,” said Calvin Roberts, M.D., executive vice president, chief medical officer, Bausch + Lomb.

A patent for Prolensa’s formulation and method of use, expiring in 2025, was recently issued to the licensor, Senju Pharmaceutical Co. Ltd., by the United States Patent and Trademark Office.

“The Prolensa filing is an important step toward bringing safe, effective and meaningful medical advances to medical professionals and their patients,” said Marvin Garrett, vice president of U.S. Regulatory Affairs, Quality Assurance and Compliance, Bausch + Lomb. “It’s also a timely example of the progress we continue to make on critical D&R programs as we work to bring together the best of ISTA Pharmaceuticals and Bausch + Lomb.”

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