Aldeyra Therapeutics Says That The FDA Stated That Reproxalap For Signs And Symptoms Of Dry Eye Disease Does Not Appear To Have Data To Support The Clinical Relevance Of The Ocular Signs To Support The Dry Eye Indication - 8K
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Aldeyra Therapeutics has been informed by the FDA that its drug, Reproxalap, for signs and symptoms of dry eye disease, lacks sufficient data to support its clinical relevance. The FDA has suggested that Aldeyra conduct an additional clinical trial to satisfy efficacy requirements. This could delay the approval of the NDA for Reproxalap beyond the target action date of November 23, 2023.
October 16, 2023 | 12:11 pm
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NEGATIVE IMPACT
Aldeyra Therapeutics' drug Reproxalap may face delays in FDA approval due to insufficient data. This could impact the company's timeline and potential revenues from the drug.
The FDA's feedback on Aldeyra's Reproxalap indicates that the drug lacks sufficient data to support its clinical relevance for dry eye disease. This could lead to delays in approval, which would impact the company's timeline for bringing the drug to market and potential revenues from the drug. This is a significant setback for Aldeyra, hence the negative score.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100