Therapy Areas: Inflammatory Diseases
US FDA approves of Vanda Pharmaceutical's VSJ-110 Investigational New Drug application
27 October 2020 -

The United States Food and Drug Administration (FDA) has approved the Investigational New Drug application (NDA) from Vanda Pharmaceuticals Inc (Nasdaq: VNDA), a specialty pharmaceutical company, to assess Vanda's Cystic Fibrosis Transmembrane Conductance Regulator activator, VSJ-110, intended for the treatment of allergic conjunctivitis, it was reported on Monday.

The initial Phase II study in human volunteers is to assess the acute anti-inflammatory effects of the product in an ocular allergic challenge model, and will evaluate the prosecretory effects using standard tear production assessments.

The outcomes from this Phase II study are intended to help guide the product's further development to treat various ocular inflammatory conditions, including dry eye. Other potential indications include chronic inflammatory eye conditions, such as atopic keratoconjunctivitis, which remain poorly addressed with current treatment options.

Vanda plans to initiate enrolment in the Phase II study by the end of 2020 and anticipates results of this study in 2021.



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