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 siriontherapeutics/.
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.
siriontherapeutics/