'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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