Aldeyra Therapeutics (ALDX) announced the resubmission of a New Drug Application to the FDA for topical ocular reproxalap, an investigational new drug candidate, for the treatment of signs and symptoms of dry eye disease. The company said the resubmission includes positive results from a recently completed dry eye disease symptom trial requested by the FDA following review of the previously submitted NDA, as well as a draft label reflecting acute activity in reducing dry eye symptoms in a dry eye chamber trial, chronic activity in reducing dry eye symptoms in a field trial, and acute activity in reducing ocular redness in two dry eye chamber trials.
"If approved, reproxalap would have the potential to be the first dry eye disease therapy for chronic use with pivotal data demonstrating acute activity in reducing dry eye symptoms and ocular redness, two characteristics of dry eye disease of primary importance to patients," said Todd Brady, CEO.
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