Aldeyra Therapeutics, Inc. revealed that it got a complete response letter from the US Food and Drug Administration on 27 November for its new drug application for reproxalap in dry eye disease, but told an investor call the following day that it has a strategy to meet the agency’s request for additional data on the drug’s efficacy in symptoms of the disease and possibly refile the application by mid-2024.
Key Takeaways
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Aldeyra got a complete response letter for reproxalap in dry eye disease, but had already been planning on a new trial to obtain needed symptom data.
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If the FDA approves Aldeyra’s proposed trial design, the company thinks it can refile its NDA during the first half of 2024
The CRL requests an additional study demonstrating efficacy in an ocular symptom of dry eye disease and Aldeyra said it has filed for a special protocol assessment that would allow it to conduct a quick and small chamber crossover trial that would largely replicate the successful TRANQUILITY-2 study, which yielded positive data on both signs and symptoms of dry eye disease in July 2022
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