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Retinoblastoma treatment granted orphan drug designation

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The U.S. Food and Drug Administration has granted orphan drug designation to Icon Bioscience for melphalan intraocular injection, its investigational product for treatment of retinoblastoma, according to a company news release.

The injection is formulated using Icon’s proprietary Verisome drug delivery technology and is designed to safely deliver therapeutic levels of the drug for an extended period via a single intravitreal injection.

The orphan drug designation provides incentives, such as extended market exclusivity, for companies to develop treatments for diseases that affect fewer than 200,000 people in the United States.