- Aldeyra Therapeutics Inc's ALDX Phase 3 TRANQUILITY-2 trial of reproxalap for dry eye disease has achieved the primary endpoint.
- Reproxalap was statistically superior to the vehicle for each of the two prespecified primary endpoints, Schirmer test and ≥10 mm Schirmer test responder proportions after a single day of dosing.
- The Schirmer test, a measure of ocular tear production, is the dry eye disease objective sign most commonly utilized for drug approval.
- Related: Aldeyra's Dry Eye Candidate Tops Vehicle In Post-Hoc Analysis Using Computer Automated Grading In Ocular Redness.
- A Type B Pre-NDA meeting will be held with the FDA in Q3 of 2022, followed by a potential NDA submission, pending enrollment in the ongoing 12-month safety trial and results from a dry eye chamber crossover trial.
- Enrollment in the crossover dry eye disease trial is complete, and results are expected in Q3 of 2022.
- Price Action: ALDX shares are up 12.2% at $3.60 during the market session on the last check Wednesday.
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