Aldeyra Therapeutics (NASDAQ:ALDX) shares plummeted more than 70% after the biotechnology company received a letter of refusal from the Food and Drug Administration (FDA) for its investigational dry eye disease therapy reproxalap.
The company said the rejection was based on insufficient evidence of efficacy in treating ocular symptoms associated with dry eye disease.
The FDA requested additional clinical trials to address methodological issues and demonstrate a positive effect on symptoms.
The company expects to re-submit its application in mid-2025 after completing additional clinical trials.
“Reproxalap remains the only late-stage topical ocular therapy suitable for chronic administration to have potentially demonstrated acute reduction in ocular redness, as well as reduction in ocular discomfort, highlighting rapid and broad activity for both the signs and symptoms of dry eye disease,” Aldeyra CEO Todd Brady said in a statement.
This marks the second FDA rejection for reproxalap. After receiving a Complete Response Letter in 2023 citing similar concerns, the company conducted additional trials but failed to meet the FDA's standards for efficacy in its second submission.
Shares of Aldeyra fell 73.7% to $1.40 on Thursday.