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Aldeyra Hopes To Refile Dry Eye Drug Reproxalap Later In 2024

 
• By Joseph Haas

Following an FDA complete response letter last November, Aldeyra has agreed with the agency on a trial design to demonstrate efficacy in ocular discomfort, which the company can complete this year.

Eye
Aldeyra will launch new Phase III study in dry eye to respond to FDA CRL

Aldeyra Therapeutics, Inc. will run an additional dry eye chamber trial of reproxalap with a primary endpoint of ocular discomfort, using a parallel group design, that will allow it to refile for approval later this year, per an agreement with the US Food and Drug Administration.

Key Takeaways

  • Aldeyra will initiate a Phase III dry eye chamber trial during the first half of 2024 to demonstrate reproxalap’s efficacy against ocular discomfort, a symptom of dry eye disease.

The FDA issued a complete response letter (CRL) for reproxalap last November, requesting further demonstration of efficacy on a symptom...

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Pipeline Watch: Five Approvals And Two Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

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