Aldeyra’s dry eye drug gets a rejection from the FDA

The FDA hand­ed down a com­plete re­sponse let­ter to Aldeyra Ther­a­peu­tics for its dry eye dis­ease drug re­prox­alap, fol­low­ing months of spec­u­la­tion about whether the drug would be ap­proved.

The com­pa­ny said the agency re­quest­ed an­oth­er clin­i­cal tri­al to fur­ther in­ves­ti­gate the drug’s ef­fi­ca­cy. Aldeyra had pre­vi­ous­ly in­formed in­vestors of that pos­si­bil­i­ty ear­li­er this year, and said Mon­day that the pro­posed tri­al is es­ti­mat­ed to cost less than $2 mil­lion, with topline da­ta ex­pect­ed in the first half of next year.

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