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The FDA rejected Aldeyra's resubmission for reproxalap, citing efficacy concerns. The company plans another trial and aims to resubmit the NDA by mid-2025.

The Company expects to have topline data from 2 trials assessing the effect of reproxalap on dry eye disease symptoms available in the second quarter of 2025.

Aldeyra Therapeutics has announced it received a complete response letter (CRL) from the FDA for its investigational topical drug reproxalap at a 0.25% dose for use in dry eye disease due to ...

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The FDA has accepted for review the resubmitted New Drug Application for reproxalap for the signs and symptoms of dry eye disease.

Aldeyra Therapeutics has resubmitted a new drug application for topical reproxalap for the treatment of signs and symptoms of dry eye disease, the company announced in a press release.“If ...