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Aldeyra Therapeutics Reports First-Quarter 2023 Financial Results and Recent Corporate Highlights
Top-Line Results from the Phase 2 Clinical Trial of ADX-2191 in Retinitis Pigmentosa Expected in the Second Quarter of 2023 Top-Line Results from the Phase 2
About this update from Aldeyra Therapeutics, Inc.
[{"type":"text","content":"\n\nTop-Line Results from the Phase 2 Clinical Trial of ADX-2191 in Retinitis Pigmentosa Expected in the Second Quarter of 2023\n\n\n\nTop-Line Results from the Phase 2 Clinical Trial of ADX-629 in Chronic Cough Expected in the Second Quarter of 2023\n\n\n\nTop-Line Results from the Phase 3 INVIGORATE-2 Trial of Reproxalap in Allergic Conjunctivitis Expected in the Second Quarter of 2023\n\n\n\nNDA Priority Review PDUFA Date for ADX-2191 for the Treatment of Primary Vitreoretinal Lymphoma is June 21, 2023\n\n\n\nNDA PDUFA Date for Reproxalap for the Treatment of Dry Eye Disease is November 23, 2023\n\n\n\nCash and Cash Equivalents of $165.0 Million as of March 31, 2023\n\n\n\n LEXINGTON, Mass.--(BUSINESS WIRE)--\nAldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to discovering and developing innovative therapies designed to treat immune-mediated diseases, today reported recent corporate highlights and financial results for the quarter ended March 31, 2023.\n\n\n“Aldeyra continues to build a robust pipeline of novel drug candidates for the treatment of immune-mediated diseases,” stated Todd C. Brady, M.D., Ph.D., President and Chief Executive Officer of Aldeyra. “Multiple regulatory and clinical catalysts are planned for the coming quarters, including PDUFA dates for ADX-2191 and reproxalap, top-line results from our Phase 2 clinical trials in retinitis pigmentosa and chronic cough, and top-line results from our Phase 3 INVIGORATE-2 trial in allergic conjunctivitis.”\n\n\n\n\nRecent Corporate Highlights\n\n\n\nEnrollment Completed in the Phase 2 Clinical Trial of ADX‑2191 in Retinitis Pigmentosa: The open-label, single-center Phase 2 clinical trial enrolled a total of eight retinitis pigmentosa patients with rhodopsin gene mutations, including the P23H gene mutation. Patients receive either monthly or twice-monthly intravitreal doses of ADX‑2191 for three months. The primary endpoint of the trial is safety. Secondary endpoints include change from baseline in visual acuity; retinal function, as assessed by foveal microperimetry, electroretinography, and dark adaptation; and retinal morphology, as assessed by optical coherence tomography. ADX-2191, an investigational drug candidate, is a novel intravitreal formulation of methotrexate, which in preclinical models of retinitis pigmentosa facilitates...