Aldeyra reproxalap meets primary endpoint in Phase 3 dry eye chamber trial; NDA resubmission planned mid-2025

Aldeyra Therapeutics, Inc.

Reproxalap statistically superior to vehicle on ocular discomfort (LS mean diff -6.5, P=0.002) in Phase 3 chamber trial (n=58 per arm).
No notable baseline differences across treatment arms; Aldeyra believes data address FDA CRL from April 2025.
NDA resubmission anticipated mid-2025 pending Type A meeting; review expected six months.
A recent field trial was numerically supportive but did not reach statistical significance; will be submitted as supportive.
No safety signals or treatment-related discontinuations; reproxalap well tolerated in over 2,900 patients studied.

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