Aldeyra to run another trial for its dry eye disease drug as part of resubmission plans
28 Mar 2024
NDA
Aldeyra Therapeutics is planning to resubmit an NDA for its dry eye disease drug in the second half of this year, though it’ll have to run another clinical trial.
The company said Thursday that the resubmission for reproxalap is contingent on positive data from another dry eye chamber clinical trial that is set to start by June. Once Aldeyra resubmits the NDA, the FDA’s review period is expected to be six months, representing about a 12-month delay to the original launch plans.
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Source: EndPoints
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