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.
Aldeyra Plans Quick Response To FDA’s CRL For Reproxalap
Aldeyra already has a special protocol assessment under review at the FDA for a trial to provide the symptom data the agency said is needed for approval of the RASP modulator in dry eye disease.
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