Sirion Therapeutics Initiates Enrollment Of Phase III Clinical Trials For The Treatment Of Inflammation Following Ocular Surgery

Sirion Therapeutics, Inc., an ophthalmic-focused biopharmaceuticals company, announced today that it has begun enrollment of two phase III clinical trials, which will evaluate ST-601 (difluprednate) in the treatment of inflammation following ocular surgery.

ST-601 (difluprednate) was acquired by Sirion last year through an exclusive licensing agreement with Senju Pharmaceutical Co., Ltd. of Japan. The agreement gives Sirion the U.S. rights to develop and market a topical ophthalmic emulsion containing the steroid compound difluprednate for the treatment of inflammatory eye diseases.

"Initiating patient enrollment in our phase III clinical trials for difluprednate is another important milestone for Sirion," said Barry Butler, President and Chief Executive Officer of Sirion Therapeutics, Inc. The company recently announced the initiation of a phase II proof of concept trial for ST- 602 (fenretinide) for the treatment of geographic atrophy. "Difluprednate is a good strategic fit with our company mission of finding treatments for sight threatening diseases and conditions. Inflammation of the eye that is untreated or undertreated can contribute to loss of sight. We hope that difluprednate will offer help to the millions of people in the U.S. that have eye surgery each year," concluded Butler.

About Sirion Therapeutics, Inc. and Sirion Holdings, Inc.

Sirion Therapeutics is a Tampa, Florida based biopharmaceutical company, with additional offices in La Jolla, California, dedicated to the development and commercialization of innovative ophthalmic products. Sirion Holdings, Inc. is Sirion's parent company. For more information regarding Sirion and the matters announced in this press release, please visit Sirion's website at http://www.siriontherapeutics.com/.

Forward-Looking Statements

This press release contains forward-looking statements and information about Sirion Holdings, Inc.'s and Sirion Therapeutics, Inc.'s business, product candidates, and product development schedule. These forward-looking statements are only predictions, are uncertain and involve substantial known and unknown risks, uncertainties and other factors which may cause actual results to be materially different from the results anticipated, expressed or implied by these forward-looking statements. Among the factors that could cause actual results to differ materially are the following: the success or failure of research, development and marketing activities, decisions by regulatory authorities regarding whether and when to approve our drug applications, and the speed with which regulatory authorizations may be achieved. Please see Sirion Holdings, Inc.'s public filings with the Securities and Exchange Commission for further discussion of these risks, uncertainties and related cautionary statements regarding our business and such forward-looking statements.

Sirion Therapeutics, Inc.
http://www.siriontherapeutics.com/