Aldeyra Therapeutics Inc. (ALDX), which, being twice denied FDA approval for its first-in-class investigational eye drop, Reproxalap, is back at the altar, with a decision due on December 16, 2025.Reproxalap is proposed for the treatment of signs and symptoms of dry eye disease, a condition that affects 39 million Americans. The disease is characterised by insufficient moisture and lubrication in the anterior surface of the eye, leading to dryness, inflammation, pain, discomfort, irritation, diminished quality of life, and in severe cases, permanent vision impairment. Reproxalap faced FDA rejection for the first time in November 2023, when the agency concluded that the submitted New Drug Application (NDA) 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.In April 2025, the FDA issued another Complete Response Letter (CRL), again stating that the NDA "failed to demonstrate efficacy in adequate and well-controlled studies" and reiterated the need for further clinical evidence focused on symptom relief.Aldeyra addressed the agency's concerns and resubmitted the NDA in June 2025 and now awaits the FDA’s final decision.ALDX closed Wednesday’s (November 26, 2025) trading at $5.59, up 6.27%.