Aldeyra Therapeutics' Dry Eye Disease Drug Review Extended to March 16, 2026

The FDA has extended the review timeline for Aldeyra Therapeutics' reproxalap New Drug Application for dry eye disease. The extended target action date is March 16, 2026. The FDA requested submission of the Clinical Study Report, which was previously submitted to the Investigational New Drug file. The FDA plans to communicate proposed labeling requests and any anticipated postmarketing requirements by February 16, 2026. Aldeyra Therapeutics shares fell 12.1% to close at $3.99 on Monday.