ISTA's Xibrom gets FDA OK to treat cataract surgery pain

By Angela McDaniels

Seattle, Jan. 30 - ISTA Pharmaceuticals Inc. said the Food and Drug Administration has approved the company's supplemental New Drug Application for Xibrom (bromfenac ophthalmic solution) 0.09%, expanding Xibrom's indications to include the treatment of pain following cataract surgery.

Xibrom, a topical, twice-daily, non-steroidal anti-inflammatory solution, was originally approved by the FDA in March 2005 for the treatment of ocular inflammation following cataract surgery.

ISTA launched Xibrom in the United States during the second quarter of 2005.

"Since Xibrom's launch, prescriptions have grown rapidly, and the product has taken a lead position in our portfolio," president and chief executive officer Vicente Anido said in a company news release.

"We are excited to receive this additional approval from the FDA, which we believe will expand the use of our product and greatly facilitate our sales force initiatives reaching the market base of approximately 10,000 ophthalmologists in the United States."

ISTA acquired U.S. marketing rights for Xibrom in May 2002 under a license from Senju Pharmaceuticals Co. Ltd., which has marketed Xibrom in Japan since 2000.

ISTA is a specialty pharmaceutical company based in Irvine, Calif., that develops and commercializes ophthalmic products.

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