Sirion Therapeutics Announces Clinical Data Presentations at the 2009 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting

TAMPA, Fla., April 30 /PRNewswire/ — Sirion Therapeutics, Inc. announced today that eight presentations related to the Company’s products, pipeline and research will be presented at the 2009 annual meeting of The Association for Research in Vision and Ophthalmology (ARVO) in Ft. Lauderdale, FL.

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These presentations include data related to Durezol(TM) (difluprednate ophthalmic emulsion) 0.05%, fenretinide, and retinal research programs from the Sirion San Diego, CA based drug discovery laboratory.

Durezol (difluprednate ophthalmic emulsion) 0.05% was approved by the U.S. Food & Drug Administration (FDA) after an expedited review in June 2008 for the treatment of post-operative inflammation and pain associated with ocular surgery. A supplemental New Drug Application (sNDA) was filed in December 2008 seeking an approval for Durezol as a treatment for endogenous anterior uveitis based partially on a head to head comparison to Pred Forte(R). The application was accepted in February 2009 by the agency and is under review.

Fenretinide is currently being evaluated in an ongoing phase II clinical trial in the treatment of geographic atrophy (GA) associated with age-related macular degeneration (AMD). The trial is a two year multicenter, randomized, double-masked, placebo controlled, dose-comparison in over 225 patients at 30 sites in the United States. A summary of the preliminary results of a planned interim analysis of this study was provided in a press release made by Sirion on April 15th, 2009. The ARVO presentations on fenretinide contain a more detailed analysis of the data obtained from the interim analysis.

Identified below are the presentations scheduled for the upcoming ARVO meeting.

Dose Uniformity of Prednisolone Acetate Ophthalmic Suspensions Compared to Durezol (difluprednate ophthalmic emulsion) 0.05%

Session Date/Start Time: Monday May 4, 8:30-10:15 am

Posterboard Number: A351 – Program Number: 1461

Durezol Compared to Pred Forte(R) in the Treatment of Endogenous Anterior Uveitis

Session Date/Start Time: Tuesday May 5, 8:30-10:15 am

Posterboard Number: D1106 – Program Number: 2697

Sirion Therapeutics Poster Presentations Featuring Fenretinide

A Phase II Multicenter, Double-Masked, Placebo-Controlled, Dose-Comparison Study of the Safety and Efficacy of Fenretinide in the Treatment of Geographic Atrophy in Subjects with Age-Related Macular Degeneration: Preliminary Demographic Data and Reasons for Screen Failure

Session Date/Start Time: Wednesday May 6, 3:45-5:30 pm

Posterboard Number: A451 – Program Number: 4918

A Phase II, Double-Masked, Placebo-Controlled, Dose-Comparison Study of the Safety and Efficacy of Fenretinide in the Treatment of Geographic Atrophy in Subjects with Age-Related Macular Degeneration: Baseline Lesion Size, Characteristics, and Preliminary Progression Data

Session Date/Start Time: Wednesday May 6, 3:45-5:30 pm

Posterboard Number: A452 – Program Number: 4919

Sirion Therapeutics Poster Presentations Featuring Retinal Research

Accumulation of Toxic Retinal Fluorophores in Various Degenerative Retinal Diseases

Session Date/Start Time: Wednesday May 6, 8:30-10:15 am

Posterboard Number: A444 – Program Number: 4188

Characterization of Fluorophores in the Diseased Retinal Pigment Epithelium

Session Date/Start Time: Wednesday May 6, 8:30-10:15 am

Posterboard Number: A427 – Program Number: 4171

Anti-Angiogenic Properties of N-(4-hydroxyphenyl) Retinamide in Ocular Tissue

Session Date/Start Time: Sunday May 3, 8:30-10:15 am

Posterboard Number: A43 – Program Number: 56

Fenretinide Ameliorates Retinal Pathology in the Ins2Akita Diabetic Mouse

Session Date/Start Time: Sunday May 3, 8:30-10:15 am

Posterboard Number: A42 – Program Number: 55

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 Therapeutic, Inc. has a diverse product portfolio which includes products that address ocular diseases and conditions including uveitis, herpetic keratitis, dry eye, and geographic atrophy associated with dry AMD. For more information, please visit http://www.siriontherapeutics.com.

SOURCE Sirion Therapeutics, Inc.