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Aldeyra’s Dry Eye Drug Gets Another Rejection from the FDA

According to the FDA, the NDA ‘failed to demonstrate efficacy in adequate and well-controlled studies in treating ocular symptoms associated with dry eyes.’

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By: Charlie Sternberg

Associate Editor

Image courtesy of Mario from Pixabay.

Aldeyra Therapeutics Inc., a biotechnology company devoted to discovering and developing innovative therapies designed to treat immune-mediated and metabolic diseases, has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for the resubmission of the New Drug Application (NDA) of reproxalap, an investigational drug candidate, for the treatment of dry eye disease. Although no manufacturing or safety issues with reproxalap were identified, the FDA stated that t...

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