Pharmacy News Article

Jun 26, 2012 (Datamonitor via COMTEX) Bausch + Lomb, an eyecare company, has submitted a new drug application, or NDA, to the FDA seeking approval for PROLENSA, or 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, or bromfenac ophthalmic solution, 0.09 percent, in a new formulation.

PROLENSA (bromfenac ophthalmic solution) is being developed as a once-daily topical nonsteroidal anti-inflammatory compound for the treatment of ocular inflammation and pain following cataract surgery. PROLENSA incorporates a lower concentration of bromfenac than the company's current once-daily NSAID, BROMDAY (bromfenac ophthalmic solution) 0.09 percent 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," stated Calvin Roberts, 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 US Patent and Trademark Office.

"The PROLENSA filing is an important step towards bringing safe, effective and meaningful medical advances to medical professionals and their patients," said Marvin Garrett, vice president of US 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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