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Aldeyra Readies Reproxalap For Dry Eye Refiling After Chamber Study Success

Awaiting Word From AbbVie On Option Exercise

 
• By Mandy Jackson

The company said earlier this year that it would resubmit reproxalap for US FDA approval before the end of 2024 once it completed another Phase III trial and is eyeing both acute and chronic use.

Woman applying eye drops on light background, closeup
Reproxalap's rapid efficacy may be differentiating in dry eye disease • Source: Shutterstock

Aldeyra Therapeutics, Inc. plans to resubmit reproxalap for US Food and Drug Administration approval to treat dry eye disease based on the positive outcome of a Phase III dye eye chamber clinical trial that the agency required before it would reconsider the company’s new drug application (NDA). Aldeyra plans to refile the NDA before the end of 2024 and expects a six-month review as it promised investors back in March when the FDA cleared the design of its chamber trial design.

Key Takeaways

  • Aldeyra reported Phase III data from a dry eye chamber study that will support resubmission of reproxalap to the US FDA.

  • The company believes...

The agency issued a complete response letter (CRL) in November 2023, denying approval of reproxalap, a reactive aldehyde species (RASP) modulator, saying that another clinical trial was needed to show...

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