Aldeyra Therapeutics resubmits reproxalap new drug application for the treatment of dry eye disease

Aldeyra Therapeutics

3 October 2024 - Aldeyra Therapeutics today announced the resubmission of a new drug application to the US FDA for topical ocular reproxalap, an investigational new drug candidate, for the treatment of signs and symptoms of dry eye disease. 

The resubmission includes previously disclosed positive results from a recently completed dry eye disease symptom trial requested by the FDA following review of the previously submitted new drug application, 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.

Read Aldeyra Therapeutics press release

Michael Wonder

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Michael Wonder

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Medicine , US , Dossier