DIET & NUTRITION 
PATIENT EDUCATION 
OBESITY/WEIGHT MANAGEMENT 
EXERCISE/TRAINING 
LEGAL MATTERS 
GUIDELINES/RECOMMENDATIONS The FDA rejected Aldeyra’s reproxalap NDA for dry eye disease, citing inconsistent trial results and failure to demonstrate efficacy across adequate, well-controlled studies. The agency raised serious concerns about the reliability of positive findings, effectively leaving the dry eye pipeline without this candidate.
Professional Impact
- The FDA found the totality of clinical evidence did not support reproxalap’s effectiveness, a high bar that signals tighter scrutiny of dry eye endpoints.
- No safety or manufacturing issues were cited, meaning the rejection rests entirely on efficacy reliability, an important distinction for pipeline watchers.
- Aldeyra does not plan additional trials and will seek a Type A meeting within 30 days to identify a path to approval.
- With $70 million in reserves through 2028, the company retains capacity to respond, but the timeline for any resubmission remains undefined.
Action Items
- Inform patients awaiting reproxalap that the drug remains unavailable with no approval timeline confirmed.
- Review current dry eye treatment protocols given continued unmet need in this therapeutic space.
- Monitor Aldeyra’s Type A meeting outcomes for signals on revised efficacy endpoints or trial design.
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