Aldeyra Therapeutics plans FDA dispute resolution request for reproxalap
ALDX•Aldeyra Therapeutics plans to submit a formal FDA dispute resolution request for reproxalap, appealing the March 16, 2026, complete response letter; the company expects to submit the request and meet with the FDA in Q4 2026.
1. Planned FDA appeal
Aldeyra Therapeutics said it plans to submit a formal dispute resolution request to the FDA for reproxalap, its treatment for dry eye disease. The request will appeal the agency’s March 16, 2026, complete response letter denying the drug’s application; Aldeyra expects to submit the request and meet with the FDA in Q4 2026.
