Sirion Therapeutics, Inc. has released results of a comparative trial evaluating the efficacy of Durezol(TM) 0.05% dosed four times daily against Allergan’s Pred Forte(R) 1%, dosed eight times daily. A topical ophthalmic corticosteroid, Durezol was indicated by the FDA in June 2008 for treating pain and inflammation related to ocular surgery. At the end of two weeks, the Durezol group achieved a mean cell grade reduction of 2.1, compared to 1.9 in the Pred Forte group, showing the potential of Durezol as a steroid.

Sirion Therapeutics Inc. has received FDA approval for its New Drug Application (NDA) for Durezol(TM). The FDA has granted the drug priority review, which means that the review would be completed in six months from the date of receipt of the NDA. The NDA is for Sirion Therapeutics’ investigational compound Durezol(TM) (difluprednate ophthalmic emulsion) 0.05%, a twice-daily steroid, as a treatment for postoperative ocular inflammation.