Aldeyra’s sights set on November PDUFA; Synbio startup scores cash
Aldeyra Therapeutics has a date at the FDA, specifically Nov. 23 for its dry eye disease drug.
After boldly claiming “approvability has been put to bed” last summer with a crossover study win, Aldeyra said Tuesday morning the US agency accepted its drug, reproxalap, for review.
Reproxalap failed a Phase III trial in late-2021, but the drug’s maker followed up with another late-stage study testing a new primary endpoint and succeeded last June. A month later, the drug cleared a crossover study, in which it met the primary endpoints tested in both of the previous Phase III trials.
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