Aldeyra's Dry Eye Disease Trial Meets Primary Endpoint, But Misses On Secondary Endpoint

  • Aldeyra Therapeutics Inc's ALDX reproxalap achieved the primary endpoint of ocular redness in the Phase 2 trial in patients with dry eye disease.
  • The ocular redness scores in the reproxalap group were statistically lower than those of vehicle.
  • Mean visual analog scale ocular dryness and discomfort scores were lower in reproxalap-treated subjects than in vehicle-treated subjects. However, differences did not reach statistical significance. 
  • Tear RASP level results from the trial are expected to be available later this quarter. 
  • No safety or tolerability concerns were observed in the trial.
  • The most common adverse event was mild and transient instillation site discomfort lasting less than one minute, similar to many prescribed topical ophthalmic medications.
  • Two Phase 3 trials of reproxalap in patients with dry eye disease, TRANQUILITY, and TRANQUILITY-2, are ongoing. 
  • For each trial, the planned enrollment is 300 patients, and the primary endpoint is ocular redness.
  • Results from the TRANQUILITY trials are expected to be released by the end of the year.
  • Price Action: ALDX shares are down 9.42% at $8.37 during the market session on the last check Tuesday.

Posted In: Briefsdry eye diseasePhase 2 TrialBiotechNewsHealth CareSmall CapMoversTrading IdeasGeneral

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