Aldeyra’s reproxalap achieves primary endpoint in Phase 3 dry eye disease trial

Aldeyra (ALDX) announced the achievement of the primary endpoint in a Phase 3 dry eye chamber trial of 0.25% reproxalap ophthalmic solution, an investigational new drug candidate, for the treatment of dry eye disease. For the prespecified primary endpoint of ocular discomfort, a symptom of dry eye disease, reproxalap was statistically significantly superior to vehicle on ocular discomfort symptom score from 80 to 100 minutes after chamber entry. Aldeyra believes that the dry eye chamber trial results, which included no notable differences in baseline scores across treatment arms, potentially address the FDA feedback received in April in response to the prior NDA. The letter identified concerns with a previously completed dry eye chamber trial that may have affected the interpretation of the results. Pending a Type A meeting with the FDA, NDA resubmission is anticipated mid-2025, and the review period is expected to be six months. There were no safety signals or treatment-related discontinuations observed in either of the recently completed clinical trials, and reproxalap was observed to be well tolerated. Reproxalap has now been studied in over 2,900 patients.