Aldeyra's Dry Eye Candidate Tops Vehicle In Post-Hoc Analysis Using Computer Automated Grading In Ocular Redness

Aldeyra Therapeutics Inc ALDX reported a post-hoc analysis from the completed Phase 3 TRANQUILITY dry eye chamber trial of reproxalap for dry eye disease.
Using computer-automated grading of digital photography from the trial demonstrated statistical significance in favor of reproxalap over the vehicle for the primary endpoint of reducing ocular redness.
As previously announced, the Phase 3 TRANQUILITY trial failed to meet the primary endpoint of ocular redness.
Aldeyra intends to discuss the post-hoc analyses and the algorithm used with the FDA before submitting a marketing application.
Also See: Aldeyra's Dry Eye Disease Trial Meets Primary Endpoint, But Misses On Secondary Endpoint.
Top-line results from another Phase 3 trial, TRANQUILITY-2, are expected in Q2 of 2022.
Pending discussion with the FDA and enrollment of the ongoing 12-month safety trial in dry eye disease patients, marketing application submission for dry eye disease is expected to occur in mid-2022.
Aldeyra intends to include ocular redness as an objective sign of dry eye disease for a marketing application.
Price Action: ALDX shares are down 6.82% at $2.46 during the market session on the last check Wednesday.