'Ap­prov­abil­i­ty has been put to bed': Aldeyra says eye drop clears three dry eye sig­nals en route to FDA

Aldeyra’s at­tempt at treat­ing dry eye dis­ease has seen a few ups and downs in re­cent years, but the biotech’s sight to ap­proval got a lit­tle clear­er Tues­day with a crossover tri­al suc­cess that will pad its case to the FDA this quar­ter.

In De­cem­ber 2021, the com­pa­ny’s drug, re­prox­alap, failed to reach sta­tis­ti­cal sig­nif­i­cance in re­duc­ing eye red­ness in a Phase III tri­al, but Aldeyra scrapped that pri­ma­ry end­point in a sep­a­rate late-stage study. The tri­al end­ed up achiev­ing the new pri­ma­ry end­point, a test mea­sur­ing tear pro­duc­tion, last month.

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