IRVINE, Calif. – The nonsteroidal anti-inflammatory drug bromfenac has received U.S. regulators’ approval for a new indication, according to Ista Pharmaceuticals.
The Food and Drug Administration approved a supplemental new drug application to expand the indications for Xibrom (bromfenac 0.09%, Ista) to include pain treatment following cataract surgery, Ista announced in a press release.
Clinical trials found that 75% of cataract patients who experienced postoperative pain after cataract surgery were pain-free within 2 days of being treated with Xibrom, and 98% were pain-free within 6 days, according to the Ista press release.
“We are excited to receive this additional approval from the FDA, which we believe will expand the use of our product and greatly,” said Vicente Anido Jr., PhD, president and chief executive officer of Ista, in the press release.
Xibrom was approved in 2005 for treating postcataract inflammation. The topical NSAID was introduced to the U.S. market in the second quarter of 2005.