regulatory
confidence high
sentiment neutral
materiality 0.60
Aldeyra plans reproxalap NDA resubmission for dry eye disease in H2 2024
Aldeyra Therapeutics, Inc.
- Dry eye chamber trial to start H1 2024; NDA resubmission expected H2 2024 if positive.
- FDA review period expected to be six months for potential resubmission.
- Cash $142.8M as of Dec 31, 2023; projected to fund operations beyond 2026.
- Primary endpoint: ocular discomfort; trial design from four prior reproxalap chamber trials.