Potentially competing with gene therapy in the unmet medical need of retinitis pigmentosa (RP), Aldeyra Therapeutics, Inc. reported statistical significance across multiple measures in a small Phase II study of its intravitreal injection formulation of methotrexate on 29 June, data the biotech said it hopes will lead to a pivotal Phase II/III study for ADX-2191 in RP.
The data came roughly a week after the US Food and Drug Administration issued a complete response letter for the drug candidate in a rare cancer, primary vitreoretinal lymphoma. In that case, Aldeyra had filed a “paper NDA” without data from new clinical studies in the sought indication, basing its application instead on “more than three decades of published literature” about the use of methotrexate in primary vitreoretinal lymphoma
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