Aldeyra hopes new data for dry-eye disease drug will satisfy FDA

Title

Aldeyra Aims for FDA Approval with New Phase 3 Data for Dry-Eye Drug Reproxalap

Keywords

Aldeyra Therapeutics
Reproxalap
FDA approval
Dry eye disease
Phase 3 clinical trial
NDA resubmission
Complete Response Letter (CRL)
Ocular symptoms
Efficacy studies
Clinical trial results

Key Facts

Aldeyra Therapeutics is seeking FDA approval for its dry-eye disease treatment, reproxalap, after previous setbacks, including two FDA rejections3 4.
The FDA's latest Complete Response Letter indicated that previous submissions failed to demonstrate efficacy in well-controlled studies for treating dry-eye symptoms, requesting at least one additional adequate and well-controlled trial4 5.

- In response, Aldeyra initiated several new studies:
a dry eye chamber trial, another chamber trial, and a six-week symptom field trial to meet FDA requirements4.
- The company has reported achieving the primary endpoint in its latest Phase 3 trial for dry eye disease symptoms1.
- Pending results from ongoing trials, Aldeyra plans to resubmit its New Drug Application (NDA) for reproxalap in mid-2025, with an anticipated six-month FDA review period1 3 5.
- Top-line results from these key clinical trials are expected in the second quarter of 2025, which will inform the planned NDA resubmission2 5.
- Reproxalap is noted as a late-stage topical ocular therapy that has shown potential for reducing both ocular redness and discomfort, significant signs and symptoms of dry eye disease5.