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Investing.com -- Aldeyra Therapeutics (NASDAQ:ALDX) stock surged 8% after the company announced it received a Special Protocol Assessment Agreement Letter from the U.S. Food and Drug Administration (FDA) for its investigational drug candidate ADX-2191 for the treatment of primary vitreoretinal lymphoma (PVRL).
The agreement outlines the design for a clinical trial that will compare cancer cell clearance in patients receiving either a single intraocular injection or eight intraocular injections of ADX-2191. This trial is expected to begin in the second half of 2025 and conclude in 2026.
ADX-2191 is a novel, vitreous-compatible formulation of methotrexate specifically designed for intraocular injection, which potentially allows for a reduced injection volume compared to current compounding methods.
"Primary vitreoretinal lymphoma is treated today off label with intravitreal injections of compounded methotrexate," stated Todd C. Brady, M.D., Ph.D., President and Chief Executive Officer of Aldeyra.
The FDA had previously accepted a literature-based New Drug Application (NDA) for ADX-2191 for Priority Review in March 2023. However, in June 2023, the company received a Complete Response Letter stating that available literature was insufficient to demonstrate efficacy and that controlled trials were required for approval.
Jones Trading analyst Catherine Novack reiterated a Buy rating and $6.00 price target on Aldeyra Therapeutics. The analyst commented, "Approval could help pave the way for ALDX-2191 in more prevalent indications, such as retinitis pigmentosa."
PVRL is a rare and potentially fatal cancer that currently lacks FDA-approved therapy.
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