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Aldeyra Plans To File Reproxalap Again With New Dry Eye Symptom Data

 
• By Joseph Haas

The biotech hopes a third time will be the charm after two FDA complete responses, with plans to position its eye drop as offering quicker onset of action.

Woman using eye lotion
Aldeyra plans to take its dry eye candidate to the FDA for a third shot at approval • Source: Alamy

Roughly a month after receiving its second US Food and Drug Administration complete response letter, Aldeyra said on 5 May that it believes new Phase II data will meet the agency’s requirements and intends to refile a new drug application for reproxalap in dry eye disease in mid-2025. If it can get to market, reproxalap could be highly competitive in dry eye disease.

Key Takeaways
  • Aldeyra obtains positive Phase III dry eye disease symptom data and hopes to refile an NDA for reproxalap, already the subject of two FDA complete response letters.

On a 6 May analyst call, CEO Todd Brady said the reactive aldehyde species (RASP)-modulating eye drop demonstrated superiority to...

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