The FDA issued a third complete response letter to Aldeyra Therapeutics for reproxalap, the company’s dry‑eye candidate, citing inconsistent efficacy across trials and a lack of substantial evidence to support approval. The agency highlighted discordant results between controlled chamber studies and field trials, questioning the reliability and meaningfulness of positive signals. Aldeyra said it will request a Type A meeting to clarify next steps. The CRL follows prior rejections and underscores regulatory scrutiny on reproducibility and clinically meaningful endpoints in ocular surface disease trials; Aldeyra’s future path will depend on identifying responsive subpopulations or new trial designs acceptable to FDA reviewers.