Aldeyra (ALDX) announced receipt of a special protocol assessment agreement letter from the FDA for ADX-2191, an investigational drug candidate, for the treatment of primary vitreoretinal lymphoma, a rare and potentially fatal cancer currently lacking FDA-approved therapy. The clinical trial proposed in the special protocol assessment will compare cancer cell clearance after 30 days of therapy in up to 20 patients following 1:1 randomization to receive either a single intraocular injection or eight intraocular injections of ADX-2191. The frequency of methotrexate injections has been linked to cancer cell clearance in patients with PVRL, and approximately five injections are required on average to achieve cancer cell clearance. The clinical trial is expected to begin in the second half of 2025 and conclude in 2026.
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