Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Sirion Therapeutics has announced that the FDA has approved its new drug application for Durezol 0.05%, a topical steroid for the treatment of postoperative ocular inflammation and pain. The approval came after a six month priority review.
Subscribe to our email newsletter
In two Phase III trials evaluating Durezol in patients diagnosed with significant postoperative inflammation (more than 10 anterior chamber cells), Durezol was found to rapidly reduced inflammation and pain. Mean intraocular pressure for all study groups remained within the normal range throughout the study.
Sirion Therapeutics plans to make Durezol commercially available in late 2008.
Barry Butler, president and CEO of Sirion Therapeutics, said: “We look forward to launching the first innovation in the strong steroid class in more than 35 years, and the first steroid to have an indication for the treatment of postoperative pain.”