ISTA Pharmaceuticals, Inc. (Nasdaq: ISTA), today announced positive preliminary results from a Phase 1/2 clinical study of bepotastine besilate nasal spray conducted in Canada for the treatment of symptoms associated with seasonal allergic rhinitis, the inflammation of the nasal passages caused by allergies. The findings demonstrated two of the three bepotastine besilate concentrations tested were effective in relieving patients' nasal symptoms after exposure to seasonal allergens. The safety data showed the drug to be well-tolerated, with adverse events consistent with those observed with other antihistamine nasal sprays and generally rated as mild. As a result of the positive outcomes, ISTA plans to submit an Investigational New Drug (IND) Application to the U.S. Food and Drug Administration (FDA) and to initiate Phase 2 clinical studies of bepotastine besilate nasal spray before the end of 2010.
Commenting on the results of the study, Timothy R. McNamara, Pharm.D., Vice President of Clinical Research and Medical Affairs of ISTA Pharmaceuticals, said, "During the clinical trials for BEPREVE®, our twice-daily prescription eye drop for ocular itching associated with allergic conjunctivitis, patients noted improvement in nasal symptoms. The Phase 1/2 study data with bepotastine besilate nasal sprays supports our initial findings with the BEPREVE ophthalmic solution on the efficacy of bepotastine for the treatment of nasal symptoms.
"The results of our nasal bepotastine Phase 1/2 clinical study in Canada show a robust patient response to the nasal spray without serious side effects, giving us confidence to move forward into Phase 2 clinical trials. We plan to file an IND application for bepotastine nasal spray and start a Phase 2 trial in Texas before year-end 2010, using one of the most potent seasonal allergy triggers, Mountain Cedar pollen. Assuming timely filing of the IND application and timely commencement and completion of the Phase 2 studies, we expect to report preliminary Phase 2 data from the Mountain Cedar pollen study during the first half of 2011."
ISTA Pharmaceuticals, Inc.