08:45 AM EDT, 06/17/2025 (MT Newswires) -- Aldeyra Therapeutics ( ALDX ) said Tuesday it resubmitted a new drug application to the US Food and Drug Administration for reproxalap, an investigational eye drop for dry eye disease.
The company said the resubmission follows a prior rejection by the US health agency, citing methodological concerns with the earlier data.
The resubmission was based on new data from the phase 2 study in which the drug achieved the primary endpoint, with no major safety issues reported, it said.
Aldeyra Therapeutics ( ALDX ) said the FDA review is expected to be completed within six months.
Shares were 2% higher in recent premarket activity.