Aldeyra Therapeutics, Inc. (ALDX) Thursday said that the European Medicines Agency (EMA) has granted orphan drug designation for ADX-2191 for the treatment of primary large B-Cell lymphomas of immune-privileged sites, including primary vitreoretinal lymphoma, a rare, aggressive, high-grade cancer .
ADX-2191 has already received orphan drug designation from the FDA for the treatment of primary vitreoretinal lymphoma and retinitis pigmentosa, and from the EMA for the treatment of inherited retinal dystrophies of the rod-dominant phenotype, including retinitis pigmentosa.
Orphan designation allows companies certain benefits, including reduced regulatory fees, clinical protocol assistance, research grants, and up to 10 years of market exclusivity in the European Union.
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