Business
Aldeyra Therapeutics Announces Positive Dry Eye Disease Pre-NDA Meeting with the FDA and Highlights Upcoming Corporate Milestones
Dry Eye Disease NDA for Reproxalap Expected to be Submitted in the Fourth Quarter of 2022 Pre-NDA Meeting for ADX-2191 for the Treatment of Primary
About this update from Aldeyra Therapeutics, Inc.
[{"type":"text","content":"\nDry Eye Disease NDA for Reproxalap Expected to be Submitted in the Fourth Quarter of 2022\n\nPre-NDA Meeting for ADX-2191 for the Treatment of Primary Vitreoretinal Lymphoma Scheduled for the Fourth Quarter of 2022\n\nResults from Part 1 of the Phase 3 GUARD Trial of ADX-2191 in Proliferative Vitreoretinopathy Expected in the Third or Fourth Quarter of 2022\n\nResults from the Phase 2 Clinical Trial of ADX-2191 in Retinitis Pigmentosa Expected in the First Half of 2023\n\nResults from the Phase 3 INVIGORATE-2 Trial of Reproxalap in Allergic Conjunctivitis Expected in 2023\n\n LEXINGTON, Mass.--(BUSINESS WIRE)--\nAldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced that, following the recent receipt of official minutes from its pre-NDA (New Drug Application) meeting with the U.S. Food and Drug Administration (FDA), the Company remains on schedule to submit an NDA in the fourth quarter of 2022 requesting marketing approval of the novel RASP modulator reproxalap, an investigational new drug, for the treatment of dry eye disease.\n\n“Based on the outcome of our pre-NDA meeting, we believe that we have aligned with the FDA on the content of the regulatory package that will support what we expect to be a uniquely comprehensive NDA submission for the treatment of dry eye disease, encompassing data demonstrating improvement that may occur within minutes of drug administration in symptoms and three different objective signs,” stated Todd C. Brady, M.D., Ph.D., Aldeyra’s President and Chief Executive Officer. “In contrast to currently available dry eye therapies that may require weeks of administration to achieve even modest benefit, the rapid onset of activity of reproxalap observed in clinical trials represents a potential paradigm shift in the treatment of dry eye disease.”\n\n\nConsistent with prior guidance, 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 natural environment settings. In addition to...