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news.Sirion Therapeutics, a biopharmaceutical company, has announced that its supplemental new drug application submitted to the FDA seeking market approval of Durezol 0.05% to treat endogenous anterior uveitis has been accepted for review.
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Durezol, developed and marketed by Sirion Therapeutics, was previously approved by the FDA for the treatment of post-operative inflammation and pain associated with ocular surgery.
The supplemental application includes data from several clinical studies, including one recently completed trial in the US of 90 patients with endogenous anterior uveitis that compared Durezol dosed QID to Pred Forte 1%, Allergan, dosed eight times a day.
Two phase III clinical trials, conducted in Japan by Senju Pharmaceuticals were also part of the application. The FDA has issued an action date of October 24, 2009 for the supplemental new drug application (sNDA).
Barry Butler, CEO of Sirion, said: “Uveitis is a debilitating and painful condition, and is one of the leading causes of blindness in the US. We are encouraged that the FDA is reviewing the application for our drug, which has the potential to treat this sight threatening condition.”