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Aldeyra Expects Mid-2025 Refiling Of Reproxalap After Second CRL

 
• By Joseph Haas

Aldeyra’s dry eye candidate reproxalap received a second FDA complete response letter, but the firm expressed confidence about refiling quickly based on two ongoing studies.

EyeDrops
Aldeyra hopes ongoing trials will provide data finally for FDA approval of reproxalap • Source: Shutterstock

Despite a second complete response letter from the US Food and Drug Administration to its new drug application for reproxalap in dry eye disease, Aldeyra expects to refile for approval during the middle of 2025 and anticipates a six-month review. On a 3 April analyst call, the company noted that the second CRL cited agency concerns about baseline imbalance in ocular discomfort scores in the trial backing the resubmitted NDA.

Key Takeaways
  • Aldeyra’s dry eye candidate reproxalap gets a second FDA complete response, this time expressing concerns about baseline disease states in treatment and vehicle arms of...

Reproxalap, a topical reactive aldehyde species (RASP) modulator, initially was filed for FDA approval in dry eye disease in 2023, backed by four pivotal studies, two each intended to demonstrate...

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