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Aldeyra Therapeutics' Resubmitted Marketing Application for Eye Disease Drug Accepted by FDA
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Aldeyra Therapeutics' Resubmitted Marketing Application for Eye Disease Drug Accepted by FDA
Nov 18, 2024 11:20 PM

08:01 AM EST, 11/18/2024 (MT Newswires) -- 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 ( ABBV ) 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 ( ABBV ) and 40% for Aldeyra.

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