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Aldeyra Therapeutics Announces that Post-Hoc Analysis Using Computer Automated Grading of Phase 3 TRANQUILITY Trial Digital Photography Demonstrated Statistical Significance in Favor of Reproxalap Over Vehicle for Primary Endpoint of Ocular Redness
Post-Hoc Analysis Using Computer Automated Grading Indicated that Reproxalap is Statistically Superior to Vehicle (p=0.020) in Reducing Dry-Eye Associated
About this update from Aldeyra Therapeutics, Inc.
[{"type":"text","content":"\n\nPost-Hoc Analysis Using Computer Automated Grading Indicated that Reproxalap is Statistically Superior to Vehicle (p=0.020) in Reducing Dry-Eye Associated Ocular Redness, the Primary Endpoint of Phase 3 TRANQUILITY Trial\n\n\nStatistical Superiority of Reproxalap over Vehicle (p=0.003) for the Primary Endpoint of Ocular Redness in the Previously Announced Phase 2 Dry Eye Chamber Trial Confirmed Using Post-Hoc Computer Automated Grading\n\n\nPending Discussion with the U.S. Food & Drug Administration (FDA), Aldeyra Intends to Include Ocular Redness as an Objective Sign of Dry Eye Disease for New Drug Application (NDA), Expected to be Submitted Mid-2022\n\n\nTRANQUILITY-2 Top-Line Results Expected in the Second Quarter of 2022\n\n\n LEXINGTON, Mass.--(BUSINESS WIRE)--\nAldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today reported that a post-hoc analysis using computer automated grading of digital photography from the completed Phase 3 TRANQUILITY dry eye chamber trial demonstrated statistical significance (p=0.020) in favor of reproxalap over vehicle for the primary endpoint of reduction of ocular redness. As previously announced, the Phase 3 TRANQUILITY trial failed to meet the primary endpoint of ocular redness as assessed by independent central reviewers.\nThis press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220517006326/en/Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) on May 18, 2022 reported that a post-hoc analysis using computer automated grading of digital photography from the completed Phase 3 TRANQUILITY and Phase 2 clinical trials demonstrated statistical significance in favor of reproxalap over vehicle for the primary endpoint of reduction of ocular redness. (Graphic: Aldeyra Therapeutics)\nWhen applied to Aldeyra’s Phase 2 dry eye chamber trial, which was completed in late 2021, the computer automated grading assessment (p=0.003) confirmed the previously announced achievement of the primary endpoint of ocular redness (p=0.016), which, similar to the Phase 3 TRANQUILITY trial, was originally assessed by independent central reviewers. Aldeyra intends to discuss the results of the post-hoc analyses, as well as the algorithm used for the computer automated assessment of ocular redness,1 with the FDA prior to NDA submission.\n\nThe computer automated grading of ...