FDA Declines Aldeyra Eye Drug Sending Shares Down 65 Percent
The FDA declined to approve reproxalap for dry eye disease citing insufficient efficacy. Aldeyra shares fell 65 percent after the third regulatory setback.
Aldeyra Therapeutics, Inc. shares plummeted 65% in premarket trading on Tuesday after the United States Food and Drug Administration (FDA) declined to approve its treatment for dry eye disease. The drug, reproxalap, was designed to address the condition where eyes fail to produce sufficient tears, causing discomfort and potential vision impairment. In its complete response letter, the FDA indicated that the drug did not demonstrate enough efficacy for approval. Aldeyra noted that the regulator raised no concerns regarding safety or manufacturing. This rejection is the third consecutive setback for the company since 2023 involving reproxalap. Aldeyra reported that it does not currently plan to conduct further clinical trials but will instead request a Type A meeting with the FDA to discuss the requirements for eventual approval.