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Dry Eye Crossover Study Could Allow Aldeyra A Quick Response To US FDA’s CRL For Reproxalap

 
• By Joseph Haas

Aldeyra’s bid to rely on a single Phase III trial after an initial one failed is rejected by FDA, but firm already has a special protocol assessment under review for a trial that could provide the symptom data it says agency needs to approve the RASP modulator in dry eye. 

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

Aldeyra Therapeutics, Inc. revealed on 27 November that it got a complete response letter from the US Food and Drug Administration for its new drug application for reproxalap in dry eye disease, but told an investor call the following day that can quickly 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...

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