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

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  • Aldeyra Therapeutics Inc (NASDAQ: ALDXreported 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.

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