FDA accepts Sirion NDA, license acquisition

Rockville, MD-The FDA has accepted Sirion Therapeutics' new drug application (NDA) for difluprednate ophthalmic emulsion 0.05% (Durezol) and has granted it priority review, the Tampa, FL-based company has announced.

The steroid has been tested as a twice-daily treatment for postoperative ocular inflammation. Under the priority review process, the start date for the 6-month review is the date of receipt of the NDA. The FDA has issued an action date of June 26.

Data from two phase III clinical studies of difluprednate will be presented at the annual meeting of the American Society of Cataract and Refractive Surgery next month in Chicago.

Under the terms of this licensing agreement, Sirion will have the rights to manufacture, sell, and distribute norketotifen for ocular use either alone or in combination with other drugs. Clinical trials of the drug are expected to begin in early 2009.

"We are very excited about the medical and market potential of the norketotifen molecule," said Roger Vogel, MD, chief medical officer of Sirion.