- 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.
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