Biotechnology company Aldeyra Therapeutics Inc (Nasdaq: ALDX) announced on Monday that the FDA has accepted for review its New Drug Application (NDA) for reproxalap, an investigational drug for dry eye disease. The FDA set a Prescription Drug User Fee Act (PDUFA) target date of 2 April 2025 for a decision.

In parallel, Aldeyra has expanded its exclusive option agreement with pharmaceutical company AbbVie Inc. Under this arrangement, AbbVie may secure a co-exclusive U.S. license for reproxalap, which would include a USD100m upfront payment (less USD6m in previously paid fees). If FDA approval is granted, Aldeyra could also receive up to USD300m in regulatory and commercial milestone payments, including a USD100m milestone at approval. The profits from commercialisation would be split 60% to AbbVie and 40% to Aldeyra.

Reproxalap is a small-molecule modulator of reactive aldehyde species (RASP), implicated in ocular inflammation. It has shown significant efficacy in late-phase trials with over 2,500 patients and demonstrated a strong safety profile, with mild site irritation as the most common adverse event.