07:39 AM EDT, 07/17/2025 (MT Newswires) -- Aldeyra Therapeutics ( ALDX ) said Thursday the US Food and Drug Administration accepted its resubmitted New Drug Application for reproxalap to treat signs and symptoms of dry eye disease.

The FDA set a Prescription Drug User Fee Act target action date of Dec. 16, the company said.

The resubmission included a clinical trial that met the primary endpoint of reducing ocular discomfort relative to vehicle control, Aldeyra said.

The company also said the trial was conducted in agreement with the FDA, which had requested additional data to support symptom efficacy.

Shares of the company were up 3.1% in recent Thursday premarket activity.