Aldeyra braces for po­ten­tial dry eye dis­ease re­jec­tion af­ter FDA says more da­ta are nec­es­sary

Aldeyra Ther­a­peu­tics is brac­ing for a po­ten­tial re­jec­tion of re­prox­alap months af­ter bold­ly tout­ing its ap­pli­ca­tion as “the most com­pre­hen­sive NDA pack­age ever sub­mit­ted for dry eye dis­ease.”

The FDA has sug­gest­ed an ad­di­tion­al clin­i­cal tri­al will be nec­es­sary for re­prox­alap to “sat­is­fy ef­fi­ca­cy re­quire­ments,” Aldeyra an­nounced Mon­day in a se­cu­ri­ties fil­ing. While the com­pa­ny has at­tempt­ed to ad­dress reg­u­la­tors’ con­cerns, it said the FDA “has not di­rect­ly opined on the suf­fi­cien­cy of the in­for­ma­tion sub­mit­ted.”

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