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Durezol

Generic name: difluprednate
Treatment for: Postoperative Ocular Inflammation

Update: Durezol Now FDA Approved - June 23, 2008

Sirion Therapeutics Receives NDA Acceptance and Priority Review From the FDA for Durezol in the Treatment of Postoperative Ocular Inflammation

TAMPA, Fla., February 27, 2008 /PRNewswire/ -- Sirion Therapeutics, Inc., a privately held ophthalmic-focused biopharmaceutical company, today announced that its New Drug Application (NDA) for Durezol 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 (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 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.

About Post-Operative Inflammation

Over five million ophthalmic surgeries are performed each year in the United States. Post-operative inflammation is a common occurrence following these procedures, and if left untreated, can interfere with a patient's visual rehabilitation or lead to further complications. While the inflammation tends to be self-resolving, some cases can lead to other serious conditions if left untreated. As there is no way to predict which patients might develop inflammatory complications, doctors often prescribe steroids and/or NSAID drops to prevent it. Most often, inflammation lasts a relatively short time, though severe forms can persist for a longer period of time.

About Durezol

Durezol (difluprednate ophthalmic emulsion) 0.05% is a topical ophthalmic steroid that has the potential to treat patients suffering from ocular inflammatory diseases, including post-operative inflammation. Durezol is a difluorinated derivative of prednisolone and has potent anti- inflammatory activity. The efficacy and safety of Durezol in ocular inflammatory diseases has been demonstrated in an extensive preclinical and clinical program in Japan.

About Sirion Therapeutics, Inc.

Sirion Therapeutics is a privately held biopharmaceutical company pursuing the discovery, development, and commercialization of products addressing unmet medical needs in the protection and preservation of eyesight. Sirion's pipeline includes four compounds: difluprednate, a topical steroid for post- operative inflammation and uveitis; ganciclovir, a topical antiviral for herpetic keratitis; cyclosporine, a topical immunomodulator for dry eye; and fenretinide, a first-in-class oral vitamin A binding protein antagonist for geographic atrophy associated with dry AMD. In addition, Sirion has preclinical programs in back of the eye diseases and allergy.

Posted: February 2008

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