Aldeyra Therapeutics Inc.’s (ALDX) drug candidate Reproxalap, proposed for the treatment of dry eye disease, is back at the FDA altar again, with a decision expected on March 16, 2026. Reproxalap is a first-in-class small-molecule modulator of RASP (reactive aldehyde species), formulated as an eye drop. Reproxalap has been twice rejected by the FDA for the treatment of dry eye disease. In November 2023, the regulatory agency turned down the New Drug Application (NDA), saying that the drug candidate did not demonstrate sufficient efficacy in treating ocular symptoms associated with dry eyes. The FDA requested at least one additional adequate and well-controlled study to support the drug's effectiveness. In response, Aldeyra completed a phase 3 dry eye chamber trial and resubmitted the NDA in October 2024.However, the second attempt also fell short, with the FDA refusing to approve Reproxalap again in April 2025, stating that it "failed to demonstrate efficacy in adequate and well-controlled studies" and reiterated the need for further clinical evidence focused on symptom relief. Addressing the concerns, the company resubmitted the NDA for Reproxalap in June 2025 and was initially assigned a decision date of December 16, 2025. In December 2025, the FDA extended the decision date to March 16, 2026.ALDX closed Tuesday’s (Feb.24, 2026) trading at $5.2, up 4.41%.