IND application for ISTA
ISTA Pharmaceuticals has submitted an Investigational New Drug (IND) application to the FDA for its eye drop formulation of bepotastine for the treatment of allergic conjunctivitis.
ISTA Pharmaceuticals has submitted an Investigational New Drug (IND) application to the FDA for its eye drop formulation of bepotastine for the treatment of allergic conjunctivitis.
Bepotastine has three primary mechanisms of action. It is a non-sedating, selective antagonist of the histamine 1 (H1) receptor; it has a stabilizing effect on mast cells and it suppresses the migration of eosinophils into inflamed tissues. ISTA plan to initiate Phase II/III clinical trials in the US during the first quarter of 2007.
An oral formulation of bepotastine has been approved in Japan since July 2000 for the treatment of allergic rhinitis.
