Phase 1/2 clinical study of bepotastine besilate nasal spray initiated for seasonal allergic rhinitis

Jul 14 2010

ISTA Pharmaceuticals, Inc. (Nasdaq: ISTA), today announced it has initiated a Phase 1/2 clinical study of bepotastine besilate nasal spray for the treatment of symptoms associated with seasonal allergic rhinitis, the inflammation of the nasal passages caused by allergies.  The randomized, placebo-controlled, parallel-group study will evaluate the safety and efficacy of three concentrations of bepotastine besilate, dosed twice daily, in an Environmental Exposure Chamber (EEC) model of allergic rhinitis caused by natural exposure to seasonal allergens.  The study also will assess the pharmacokinetics (PK) of the investigational nasal sprays.

Following initial screening, 96 patients will be randomized into the Phase 1/2 clinical study.  During the study, patients will be exposed to pollen in the EEC and will grade their individual symptoms at select time intervals prior to and following dosing with bepotastine besilate nasal spray or placebo.  Reported symptoms will include both nasal symptoms and ocular symptoms.  Safety will be evaluated based on several variables, including adverse events, electrocardiograms, and the mean grades for questions on a brief satisfaction and tolerability questionnaire completed at the end of the study.  In addition, PK data on the three dose concentrations of bepotastine besilate nasal spray will be assessed based on blood draws from a subset of patients.

"This milestone attests to the continuing momentum of our programs addressing the allergy market," stated Vicente Anido, Jr., Ph.D., President and Chief Executive Officer of ISTA.  "Last year, we received FDA approval for BEPREVE, our eye drop treatment for itching associated with allergic conjunctivitis.  We now are looking forward to potentially expanding our allergy franchise with a formulation that can treat nasal allergies."

ISTA expects to complete the Phase 1/2 clinical study of bepotastine besilate nasal spray and announce preliminary results from the study in the fall of 2010.