TAMPA, Fla., June 22 /PRNewswire/ -- Sirion Therapeutics, Inc., an ophthalmic-focused pharmaceutical company, announced today that it has reached an exclusive licensing agreement with Senju Pharmaceutical Co., Ltd. of Japan for the U.S. rights to develop and market a topical ophthalmic emulsion containing the steroid compound difluprednate for the treatment of inflammatory eye diseases.
"We are excited about the potential that this product brings to Sirion," said Roger Vogel, MD, Sirion's Chief Medical Officer. "We believe that this strong steroid can fill a gap in the current treatment options for moderate and severe inflammatory diseases of the eye."
Adds Dr. Glenn Jaffe, Professor of Ophthalmology and Director of the Uveitis Service at Duke University: "Difluprednate ophthalmic emulsion would become the first high potency steroid launched in ophthalmology in over a decade. This has the potential to be a significant addition to our treatment options for serious inflammatory eye diseases that cause blindness."
Under the agreement, Sirion will have the rights to develop, use, obtain governmental approval for, manufacture, sell, distribute and promote difluprednate formulated as an ophthalmic emulsion and/or suspension throughout the U.S. and all U.S. territories and possessions. Terms were not disclosed.
Sirion Chairman and CEO Barry Butler said the company expects to file an Investigational New Drug (IND) application for difluprednate ophthalmic emulsion with the U.S. Food and Drug Administration (FDA) by the end of 2006, and plans to commence Phase III trials in the U.S. during the first half of 2007.
About Sirion Therapeutics
Sirion Therapeutics is a Tampa, FL-based company dedicated to the development and commercialization of innovative ophthalmic products. For more information, visit http://www.siriontherapeutics.com .
Sirion Therapeutics, Inc.