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
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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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