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Aldeyra Therapeutics Reports Second-Quarter 2022 Financial Results and Recent Corporate Highlights
Pre-NDA (New Drug Application) Meeting with the U.S. Food and Drug Administration (FDA) Scheduled for the Third Quarter of 2022 to Discuss NDA Submission of
About this update from Aldeyra Therapeutics, Inc.
[{"type":"text","content":"\n\nPre-NDA (New Drug Application) Meeting with the U.S. Food and Drug Administration (FDA) Scheduled for the Third Quarter of 2022 to Discuss NDA Submission of Reproxalap for the Treatment of Dry Eye Disease\n\n\nPre-NDA Meeting with the FDA Planned for the Second Half of 2022 to Discuss NDA Submission of ADX-2191 for the Treatment of Primary Vitreoretinal Lymphoma\n\n\nTop-line Results from Phase 3 GUARD Trial of ADX-2191 in Proliferative Vitreoretinopathy Expected in the Second Half of 2022\n\n\nTop-line Results from Phase 2 Clinical Trial of Oral RASP Modulator ADX-629 in Acute Alcoholic Hepatitis Expected in the Second Half of 2022\n\n\nCash, Cash Equivalents, and Marketable Securities of $196.7 Million as of June 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 June 30, 2022.\n\n“The second half of 2022 is highlighted by planned new drug applications in dry eye disease and primary vitreoretinal lymphoma, two diseases that are currently sub-optimally treated,” stated Todd C. Brady, M.D., Ph.D., President and CEO of Aldeyra. “In addition, we look forward to announcing the results of the Phase 3 GUARD trial of ADX-2191 in proliferative vitreoretinopathy later this year, as well as the Phase 2 results of the oral RASP modulator ADX-629 in a challenge model of acute alcoholic hepatitis.”\n\n\nRecent Corporate Highlights\n\n\nPositive Results from the Dry Eye Disease Chamber Crossover Clinical Trial: Reproxalap was statistically superior to vehicle for each of the two prespecified primary endpoints, ocular redness in a dry eye chamber (P=0.0004) and Schirmer test (P=0.0005), a measure of tear production, after a single day of dosing. The secondary endpoint of Schirmer test ≥10 mm responder analysis, which was multiplicity-controlled and has been reported to correlate with symptomatic improvement in dry eye disease,1 was also achieved (P=0.0361). Rapid and statistically significant reductions in patient-reported ocular discomfort and dryness were observed in the dry eye disease chamber.\n\n\nPositive Results from th...