Icon’s Melphalan Intraocular Injection Granted U.S. Orphan Drug Status Designation for the Treatment of Retinoblastoma
Sunnyvale, CA – January 3, 2013 – Icon Bioscience, Inc., (IBI), a privately held biopharmaceutical company that specializes in the development and commercialization of novel ophthalmic pharmaceuticals, today announced that melphalan intraocular injection, the company’s investigational product for the treatment of retinoblastoma, has been granted Orphan Drug Designation by the U.S. Food & Drug Administration (FDA).
Orphan Drug Designation is generally granted to drugs or biologics intended for treatment of rare diseases and disorders, i.e., those affecting fewer than 200,000 people in the U.S. This designation conveys special incentives to the sponsor, including tax credit for fifty percent of the cost of clinical trials, prescription drug user fee waiver, and seven years of U.S. market exclusivity for the drug or biologic upon FDA approval.
About Melphalan Intraocular Injection
Icon’s melphalan intraocular injection is formulated using its proprietary Verisome® drug delivery technology. It is designed to safely deliver therapeutic levels of the drug for an extended period of time using a single intravitreal injection.
About the Verisome Drug Delivery Technology
The Verisome® drug delivery technology was invented by the Founder of Icon Bioscience, Inc., Vernon G. Wong, MD. The technology encompasses over 20 related, but distinct, novel and proprietary drug delivery systems. Highly versatile, it is capable of incorporating a broad range of active agents including small molecules, proteins and monoclonal antibodies and can deliver drugs in a controlled release manner for up to a year with a single injection.
About Icon Bioscience, Inc.
Icon Bioscience, Inc., (IBI), is a privately held biopharmaceutical company that specializes in the development and commercialization of novel ophthalmic pharmaceuticals based on its Verisome® drug delivery platform technology. IBI is developing a broad portfolio of clinically superior specialty pharmaceuticals targeting all major ophthalmic indications including macular edema, glaucoma, age-related macular degeneration and cataract surgery. IBI has also entered into agreements with multiple international pharmaceutical companies interested in the use of the Verisome® technology for their own ophthalmic products. For more information, please refer to www.iconbioscience.com.
Category: Icon Bioscience