Aldeyra Therapeutics presents reproxalap regulatory update in corporate overview
ALDX•Aldeyra Therapeutics submitted a formal dispute resolution request for reproxalap in dry eye disease after three FDA complete response letters; a meeting with the FDA’s Office of New Drugs is expected in the fourth quarter of 2026. The company reported $41 million in cash as of September 30, 2026, and an AbbVie licensing option that includes up to $200 million in payments.
1. FDA dispute request
Aldeyra Therapeutics submitted a formal dispute resolution request for reproxalap in dry eye disease following three FDA complete response letters. The latest letter found insufficient evidence of effectiveness but did not request further clinical trials. A meeting with the FDA’s Office of New Drugs is expected in the fourth quarter of 2026.
2. Cash and licensing option
Aldeyra reported cash and cash equivalents of $41 million as of September 30, 2026, sufficient to fund operations into 2029. AbbVie’s licensing option includes a $100 million upfront payment less option fees, with a further $100 million contingent on FDA approval.
