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Aldeyra Therapeutics Reports Third-Quarter 2022 Financial Results and Recent Corporate Highlights
New Drug Application (NDA) Submission of Reproxalap for the Treatment of Dry Eye Disease on Schedule for the Fourth Quarter of 2022 Pre-NDA Meeting with the
About this update from Aldeyra Therapeutics, Inc.
[{"type":"text","content":"\n\nNew Drug Application (NDA) Submission of Reproxalap for the Treatment of Dry Eye Disease on Schedule for the Fourth Quarter of 2022\n\n\nPre-NDA Meeting with the U.S. Food and Drug Administration (FDA) Scheduled for the Fourth Quarter of 2022 to Discuss NDA Submission of ADX-2191 for the Treatment of Primary Vitreoretinal Lymphoma\n\n\nTop-Line Results from the Phase 2 Clinical Trial of Oral RASP Modulator ADX-629 in Acute Alcoholic Hepatitis Expected by the End of 2022\n\n\nType C Meeting with the FDA Planned for the First Half of 2023 to Discuss Completion of Clinical Development of ADX-2191 for the Treatment of Proliferative Vitreoretinopathy\n\n\nTop-Line Results from the Phase 2 Clinical Trial of ADX-2191 in Retinitis Pigmentosa Expected in the First Half of 2023\n\n\nCash, Cash Equivalents, and Marketable Securities Exceeding $185 Million as of September 30, 2022\n\n\nManagement to Host Conference Call at 8:00 a.m. ET Today\n\n\n LEXINGTON, Mass.--(BUSINESS WIRE)--\nAldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a clinical-stage biotechnology company developing innovative therapies designed to treat immune-mediated diseases, today reported recent corporate highlights and financial results for the quarter ended September 30, 2022.\n\n“Now with two product candidates that could generate revenue as soon as next year, Aldeyra remains a leader in the development of systems-based therapeutic approaches for the treatment of diseases characterized by inflammation,” stated Todd C. Brady, M.D., Ph.D., President and CEO of Aldeyra.\n\n\nRecent Corporate Highlights\n\n\nPre-NDA Meeting with the FDA for Reproxalap in Dry Eye Disease: Following the receipt of official minutes from its pre-NDA meeting with the FDA, Aldeyra remains on schedule to submit an NDA requesting marketing approval of the novel RASP modulator reproxalap in the fourth quarter of 2022. With results from five adequate and well-controlled completed clinical trials, Aldeyra intends to submit the NDA with data for ocular dryness symptom score, ocular redness, Schirmer test, and Schirmer test ≥10 mm responder analysis. The NDA efficacy package is expected to include activity ranging from within minutes of drug administration to up to 12 weeks of treatment, crossover and parallel-group clinical trial designs, and assessment in dry eye chamber challenge and natur...