FX.co ★ Aldeyra Therapeutics Says FDA Accepts NDA For Reproxalap In Dry Eye Disease

Aldeyra Therapeutics, Inc. (ALDX) has announced that the U.S. Food and Drug Administration (FDA) has accepted the resubmitted New Drug Application (NDA) for topical ocular reproxalap, an innovative investigational drug candidate aimed at addressing the symptoms of dry eye disease. The FDA has set a Prescription Drug User Fee Act (PDUFA) date for April 2, 2025.

In parallel with the NDA acceptance, Aldeyra has expanded its exclusive option agreement with AbbVie, Inc. (ABBV). Under this agreement, established on October 31, 2023, AbbVie has the option to obtain a co-exclusive license to develop, manufacture, and market reproxalap within the United States.

Should AbbVie exercise this option, the terms stipulate a $100 million upfront cash payment to Aldeyra, adjusted by $6 million in previously paid option fees. Furthermore, Aldeyra stands to gain up to $300 million in regulatory and commercial milestone payments, which includes a $100 million payout contingent upon FDA approval of reproxalap for dry eye disease.

In terms of commercialization within the U.S., Aldeyra and AbbVie will share profits and losses, with AbbVie receiving 60% and Aldeyra 40%. The expanded agreement mandates that Aldeyra will start certain pre-commercial activities, funded 60% by AbbVie and 40% by Aldeyra upon execution of the option.

AbbVie has independently begun certain pre-commercial planning activities as well. The option's expiration has been amended to extend to 10 business days following any potential FDA approval of reproxalap for dry eye disease.