Aldeyra Seeks FDA Feedback on Reproxalap After Multiple Complete Response Letters
- Aldeyra Therapeutics seeks FDA feedback on reproxalap after three complete response letters regarding its efficacy.
- The latest CRL requested proof of 'totality' of evidence, without requiring additional clinical trials.
- An upcoming Type A meeting will provide preliminary FDA comments, with an investor update expected 30 days later.
Aldeyra Therapeutics (ALDX) focuses on its dry eye disease candidate reproxalap as it seeks feedback from the FDA following three complete response letters (CRLs) questioning the efficacy of the drug.
Navigating the FDA's Feedback
CEO Todd Brady mentions that the latest CRL did not require additional clinical trials but requested proof of the 'totality' of evidence for approval. The company anticipates receiving preliminary comments from the FDA, to be discussed in an upcoming Type A meeting.
An update for investors is expected 30 days after this meeting. While the likelihood of a reconsideration of the approval seems low based on past interactions, the company may appeal the FDA’s decision through the Formal Dispute Resolution Request if necessary.
Clinical Trial Findings Under Scrutiny
Recently, the FDA identified five clinical trials related to reproxalap that were included in the CRL. Aldeyra concurs that two of these trials did not yield statistically significant results, but disputes the conclusions drawn from three others.
Commitment to Transparency
Brady emphasizes transparency by allowing investors to review the data and findings from the trials in question as the company navigates this critical period.
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