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

Aldeyra 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.

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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)

When 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.

The computer automated grading of redness in the completed Phase 3 TRANQUILITY and Phase 2 clinical trials of reproxalap is based on digital images captured by portable cameras fitted with eye cups to standardize distance, lighting, focus, hue, and contrast. The assessment consisted of automated selection of temporal conjunctiva from images of subjects focusing on nasal targets in the eye cup. Redness intensity was averaged across all pixels in the selected region, and combined with vessel geometry to generate a theoretical maximum score of 255. The average baseline score from the post-hoc analyses of the Phase 3 TRANQUILITY and Phase 2 clinical trials was approximately 18.