- TRANQUILITY Primary Endpoint of Ocular Redness Not Met, but Statistical Significance Achieved for Secondary Endpoint of Schirmer Test (p=0.0001), an Approvable Sign of Dry Eye Disease
- Primary Endpoint of TRANQUILITY-2 Trial Modified to be Met if Either Ocular Redness or Schirmer Test Achieved; Target Enrollment Increased from 300 to up to 400 Patients; Top-Line Results Expected Mid-2022
- Dry Eye Disease NDA Submission Expected Mid-2022, Pending Safety Trial Enrollment and Outcome of TRANQUILITY-2
- Company to Host Conference Call at 5:00 p.m. ET Today
LEXINGTON, Mass.--(BUSINESS WIRE)-- Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra or the Company), a biotechnology company developing novel immune-modulating therapies to treat ocular and systemic diseases, today announced top-line results from the Phase 3 TRANQUILITY Trial of 0.25% reproxalap ophthalmic solution (reproxalap), an investigational product candidate for the treatment of dry eye disease.
Although the primary endpoint of ocular redness was not met in TRANQUILITY, statistical significance (p=0.0001) was achieved for the dry eye disease sign of Schirmer test, a secondary endpoint. Statistical significance (p