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news.The FDA has approved an expanded indication for Ista Pharmaceuticals' Xibrom to cover the use of the drug in the treatment of pain following cataract surgery.
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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.
“Since Xibrom’s launch, prescriptions have grown rapidly, and the product has taken a lead position in our portfolio. We are excited to receive this additional approval from the FDA,” said Dr Vicente Anido, Jr, president and CEO of Ista.
Senju Pharmaceuticals Co has marketed the product in Japan since 2000 with over 7.9 million uses since that time. Ista acquired US marketing rights for Xibrom in May 2002 under a license from Senju.
After licensing the drug, Ista completed two pivotal phase III clinical studies of Xibrom in the US. In these studies involving 527 patients, a statistically significant proportion of patients treated with Xibrom achieved treatment success, defined as the complete absence of ocular inflammation compared to those patients who received placebo.