Aldeyra plunges after FDA declines to approve experimental dry eye drug

Shares of biotech firm Aldeyra Therapeutics ALDX.O fall 74% to $1.12 premarket

Co says the FDA declined to approve its application for experimental dry eye drug, reproxalap, citing lack of reliable evidence it works

FDA in its so-called complete response letter flagged inconsistent results across trials and said studies did not clearly show benefit on signs and symptoms - ALDX

Agency found no safety or manufacturing issues, but advised ALDX to analyze failed trials and patient subgroups, co says

Co says it will not run new trials and plans to seek a meeting with the FDA to discuss next steps

Dry eye disease is a common condition where the eyes do not make enough tears or the right quality of tears, causing irritation and blurred vision

Shares up ~4% in 2025