Overview
- The new Complete Response Letter is the third rejection of reproxalap since 2023.
- The FDA raised no safety or manufacturing concerns in the letter.
- The agency did not request new trials, instead urging analysis of failed studies and potential responder subgroups.
- Aldeyra plans to request a Type A meeting to discuss potential steps toward approval.
- Shares fell about 69% to near a 52-week low, while the company reported roughly $70 million in cash expected to fund operations into 2028.