BEPOMAX^TM  Bepotastine Nasal Spray

In the ISTA allergy product development program, we are developing a proprietary nasal formulation of bepotastine for the treatment of allergic rhinitis. In September 2007, we obtained exclusive North American rights to nasal dosage forms of bepotastine, an investigational product for the treatment of allergy symptoms, from Mitsubishi Tanabe Pharma Corporation (formerly Tanabe Seiyaku Co., Ltd.). Based upon 2011 data from IMS, we estimate the U.S. allergic rhinitis market to be approximately $2.5 billion in sales, with the nasal antihistamine component comprising about 16% of all prescriptions.

In October of 2010, ISTA announced positive, preliminary results from the Phase 1/2 Clinical Study of bepotastine besilate nasal spray for the treatment of symptoms associated with seasonal allergic rhinitis. As a result of the positive outcomes, ISTA submitted an Investigational New Drug (IND) Application to the U.S. Food and Drug Administration (FDA) in November 2010 and initiated Phase 2 clinical studies of BEPOMAX in December 2010. The company announced positive preliminary data for BEPOMAX in April of 2011.
 

BEPOSONE^TM  Bepotastine/Steroid Nasal Spray Combination
In addition to the bepotastine nasal spray, we are developing a combination antihistamine / steroid nasal spray, with bepotastine as the antihistamine component, for the treatment of allergic rhinitis. Based on 2011 data from IMS Health, we estimate the U. S. allergic rhinitis market to be approximately $2.5 billion in sales, with the nasal steroid component comprising about 86% of all prescriptions.

ISTA initiated a follow-on Phase 2 study to the BEPOMAX nasal study with the combination formulation, BEPOSONE, in January of 2012 during the Mountain Cedar pollen season. The company expects to announce preliminary results the first half of 2012.