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Aldeyra Plans Quick Response To FDA’s CRL For Reproxalap

 
• By Joseph Haas

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.

Dry eye disease
Aldeyra hopes it can quickly refile its NDA for dry eye disease • Source: Shutterstock

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

  • 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.

    ...

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...

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