Aldeyra receives FDA Special Protocol Assessment for ADX-2191 in primary vitreoretinal lymphoma

Aldeyra Therapeutics, Inc.

SPA agreement provides FDA alignment on clinical trial design for ADX-2191 (methotrexate injection) to treat PVRL, a rare and fatal cancer with no approved therapy.
Trial will randomize up to 20 patients 1:1 to a single intravitreal injection vs. eight injections; primary endpoint is cancer cell clearance at 30 days.
Trial expected to start H2 2025 and conclude in 2026; positive SPA may support NDA resubmission with one adequate and well-controlled study plus literature.
Prior NDA for ADX-2191 received a Complete Response Letter in June 2023 due to insufficient literature-based efficacy evidence.
ADX-2191 is a novel, vitreous-compatible methotrexate formulation designed for intraocular injection potentially reducing injection volume vs. compounded methotrexate.

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