Aldeyra Therapeutics announced on Tuesday that the U.S. Food and Drug Administration (FDA) has declined to approve its drug for treating an eye disease, causing the company's stock to plunge 65% in pre-market trading.

The drug, named reproxalap, is intended for the treatment of dry eye disease (DED), a condition characterized by insufficient or poor-quality tear production that leads to eye discomfort and potential vision issues.

In its complete response letter, the FDA indicated that the drug failed to demonstrate sufficient efficacy to warrant approval. Aldeyra stated that the regulatory agency did not raise concerns regarding the drug's safety or manufacturing processes.

This marks the third consecutive setback for Aldeyra. Since 2023, the company has faced multiple regulatory challenges concerning reproxalap.

The company mentioned it currently has no plans to conduct additional clinical trials. Instead, it will request a Type A meeting with the FDA to discuss the requirements necessary for obtaining approval.