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news.ISTA Pharmaceuticals has commenced a randomised, placebo-controlled, parallel-group Phase 1/2 Bepotastine Besilate nasal spray clinical study for the treatment of symptoms associated with seasonal allergic rhinitis.
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In the study, ISTA Pharma is expected to 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 is also expected to investigate the pharmacokinetics (PK) of the investigational nasal sprays. 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.
Vicente Anido, president and CEO of ISTA Pharma, said: “This milestone attests to the continuing momentum of our programs addressing the allergy market. 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.”