Throughout 2024 and 2025, Aldeyra's made forward-looking statements regarding the development and regulatory prospects of reproxalap for the treatment of dry eye disease. Management described the NDA submission and review process in terms that conveyed optimism about the likelihood of FDA approval. The Company's August 19, 2025 8-K filing and subsequent public communications continued to present the reproxalap program as a central focus of its pipeline and a key driver of near-term commercial potential.
The FDA's Complete Response Letter on March 17, 2026 stated that reproxalap had not demonstrated sufficient efficacy. Prior to the CRL, the Company's public statements emphasized positive aspects of the drug's clinical data and regulatory prospects. Levi & Korsinsky is investigating whether Aldeyra failed to disclose material information about efficacy risks that would have altered the forward-looking picture presented to shareholders.
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