- Aldeyra Therapeutics Inc (NASDAQ: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.
