Aldeyra Therapeutics (ALDX) said Monday that the US Food and Drug Administration has accepted its resubmitted new drug application for its topical ocular reproxalab, a treatment for dry eye disease.
The company said the FDA has assigned a Prescription Drug User Fee Act date of April 2.
Aldeyra has also expanded its option agreement with AbbVie (ABBV), which was entered into in October and could give the latter a co-exclusive license to develop, manufacture and commercialize the drug candidate in the US.
If AbbVie exercises the option, Aldeyra will receive a $100 million upfront payment, plus up to $300 million in milestone payments.
The company said it would share profits from the commercialization of reproxalap in the US under a split of 60% for AbbVie and 40% for Aldeyra.
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