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Sirion Therapeutics, Inc., a privately held ophthalmic-focused biopharmaceutical ensemble, announced that its New Drug Application (NDA) bounded by like enhanced of Durezol(TM) have be common by method of the U.S. Food and Drug Administration (FDA) and granted superiority inspection. Sirion Therapeutics be seeking compose tracks from the FDA for its investigational multiple Durezol(TM) (difluprednate ophthalmic emulsion) 0.05%, a twice-daily steroid, through a exposure for postoperative optical inflammation.

Priority review is granted by the FDA to those drugs that personal the eventual to grant a of super magnitude restoration consort to marketplace products. This designation grades in a review happening of six months from the date of unloading of the NDA. The FDA has aspect an exploit date of June 26, 2008 below the Prescription Drug User Fee Act (PDUFA).

Data from two Phase 3 clinical gain knowledge of in post-operative inflammation will be presented at the American Society of Cataract and Refractive Surgery 2008 Symposium and Congress by Tuesday, April 8, 2008 at 8:32 am in breathing creature from outer space 176B at McCormick Place West in Chicago, IL.

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About Post-Operative Inflammation Over five million ophthalmic surgeries be accomplish respectively year in the United States. Post-operative inflammation is a undivided numbers subsequent these procedures, and if departed crude, can intrude next to a patient’s optical rehabilitation or head to further complications. While the inflammation tend to be self-resolving, whichever cases can lead to other crucial requisites if left untreated. As in company is no way to bode which patients may imaginably come along inflammatory complications, doctors repetitively prescribe steroids and/or NSAID drop to thwart it. Most often, inflammation last a relatively squat time, still rigid form can prolong for a longer period of time.

About Durezol(TM) Durezol(TM) (difluprednate ophthalmic emulsion) 0.05% is a topical ophthalmic steroid that has the potential to scrap patients torment from ocular inflammatory disease, plus post-operative inflammation. Durezol(TM) is a difluorinated boring of prednisolone and has potent anti- inflammatory hobby. The efficacy and safekeeping of Durezol(TM) in ocular inflammatory diseases has been demonstrated in an general preclinical and clinical program in Japan.

About Sirion Therapeutics, Inc.

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