Sirion Therapeutics, Inc., a privately held ophthalmic-focused biopharmaceutical company, today announced that its New Drug Application (NDA) for Durezol(TM) has been accepted by the U.S. Food and Drug Administration (FDA) and granted priority review. Sirion Therapeutics is seeking approval from the FDA for its investigational compound Durezol(TM) (difluprednate ophthalmic emulsion) 0.05%, a twice-daily steroid, as a treatment for postoperative ocular inflammation.
Priority review is granted by the FDA to those drugs that have the potential to provide a significant improvement compared to marketed products. This designation results in a review period of six months from the date of receipt of the NDA. The FDA has issued an action date of June 26, 2008 under the Prescription Drug User Fee Act (PDUFA).
Data from two Phase 3 clinical studies in post-operative inflammation will be presented at the American Society of Cataract and Refractive Surgery 2008 Symposium and Congress on Tuesday, April 8, 2008 at 8:32 am in room 176B at McCormick Place West in Chicago, IL.
Durezol(TM) is the trademark of Sirion Therapeutics Inc. and is currently under review by the U.S. Food and Drug Administration and has not yet been cleared as the trade name for commercial use.