FDA accepts Aldeyra's NDA for reproxalap for dry eye disease; PDUFA Nov 23, 2023

Aldeyra Therapeutics, Inc.

FDA accepted NDA for reproxalap, a first-in-class RASP modulator, for signs and symptoms of dry eye disease.
PDUFA target action date set for November 23, 2023.
FDA noted no filing review issues identified and no advisory committee meeting currently planned.
NDA supported by five adequate and well-controlled trials; reproxalap studied in over 2,000 patients with no major safety concerns.
Aldeyra believes reproxalap could address need for rapid, durable therapy for dry eye patients dissatisfied with current options.

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