The FDA issued a third complete response letter to Aldeyra Therapeutics for reproxalap, the company’s dry eye disease candidate, citing inconsistent and insufficient evidence of efficacy across its clinical program. The agency concluded that the totality of trials did not demonstrate reliable, clinically meaningful benefit and noted mixed Phase 3 field trial outcomes. Aldeyra said the agency did not request a new trial but recommended the company explore why some studies failed and identify subpopulations that might benefit. The biotech plans to request a Type A meeting to clarify next steps. Drug developers should note the agency’s emphasis on consistent, well‑controlled evidence for symptomatic ophthalmology endpoints and the challenge of reconciling chamber‑based efficacy signals with real‑world field trial results when seeking approval.