Aldeyra plans NDA re-filing as reproxalap hits Phase III goal
US ophthalmic drug developer Aldeyra Therapeutics (Nasdaq: ALDX) saw its shares climb almost 22% to $5.10 on Friday, when it released new clinical trial data.
Aldeyra announced the achievement of the primary endpoint in a Phase III randomized, double-masked, vehicle-controlled dry eye chamber clinical trial of 0.25% reproxalap ophthalmic solution, an investigational new drug candidate, for the treatment of dry eye disease.
Reproxalap was statistically superior to vehicle for the prespecified primary endpoint of ocular discomfort (P=0.004), a US Food and Drug Administration (FDA)-accepted symptom of dry eye disease.
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