Aldeyra to appeal FDA's March 16 CRL for reproxalap dry eye; cash runway extended to 2029

Aldeyra Therapeutics, Inc.

Plans Formal Dispute Resolution Request to FDA's Office of New Drugs appealing the March 16, 2026 Complete Response Letter denying approval of reproxalap for dry eye disease.
FDRR submission and OND meeting expected in Q4 2026; FDA has issued three CRLs for reproxalap after the original NDA and two resubmissions.
Most recent CRL did not request further trials but said totality of evidence from completed trials does not support effectiveness; prior two CRLs recommended an additional clinical trial.
Aldeyra cites data from nine adequate and well-controlled clinical trials, five of which achieved all multiplicity-controlled primary endpoints.
Reported $45.1M cash and equivalents as of June 30, 2026; projected operational cash runway extended into 2029.

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