ISTA commences bepotastine besilate nasal spray Phase 2 study in seasonal allergic rhinitis

Dec 14 2010

ISTA Pharmaceuticals, Inc. (Nasdaq: ISTA), today announced it has initiated a Phase 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 environmental study will evaluate the safety and efficacy of bepotastine besilate, dosed twice daily, in patients presenting with allergic rhinitis caused by one of the most potent seasonal allergy triggers, Mountain Cedar pollen.

ISTA expects to enroll approximately 600 patients in Texas who will be treated with either bepotastine besilate nasal spray or placebo for two weeks. Patients will grade both individual nasal and ocular symptoms on a daily basis.

"This nasal spray drug candidate represents an expansion of our focus in prescription allergy treatments, which currently includes BEPREVE® (bepotastine besilate ophthalmic solution) 1.5% for the treatment of ocular itching associated with allergic conjunctivitis,"  commented Vicente Anido, Jr., Ph.D., President and Chief Executive Officer of ISTA. "The results from our Phase 1/2 clinical study of bepotastine besilate nasal spray, announced in October 2010, showed a robust patient response to the nasal spray without serious side effects.  We expect to have preliminary data from this Phase 2 Mountain Cedar pollen study during the first half of 2011."

ISTA submitted the Investigational New Drug (IND) Application to the U.S. Food and Drug Administration (FDA) for bepotastine besilate nasal spray in November 2010.