ISTA Pharmaceuticals has announced results from a Phase 2 randomized, placebo-controlled, parallel-group environmental clinical study of its Beposone bepotastine besilate/steroid nasal spray for the treatment of seasonal allergic rhinitis. According to the company, the study showed that Beposone produced statistically significant improvements in nasal symptoms of patients exposed to Mountain Cedar pollen than did a placebo nasal spray. Significant improvement began on day 1 of therapy and and continued over the two-week treatment period. A subgroup of patients who performed frequent evaluation of nasal symptoms also showed significant improvement within 15 minutes after dosing.
ISTA VP of Clinical Research and Medical Affairs Timothy R. McNamara said, “We are very encouraged by the results of the Beposone Phase 2 pilot study, which shows promise for the use of a combination bepotastine besilate/steroid nasal spray for treatment of allergic rhinitis. Since antihistamines and steroids are often prescribed at the same time to patients for the treatment of seasonal allergic rhinitis, we believe there is a need for a combination product that brings together these two effective treatments in one convenient nasal spray formulation.”
The company expects to complete several more Phase 2 studies of Beposone and the single-agent Bepomax nasal spray before beginning its Phase 3 program in 2013.
In March of this year, ISTA agreed to be acquired by Bausch + Lomb, and the two companies recently announced that they have received early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 and that they expect the deal to close during the second quarter of 2012.
Read the ISTA press release on the study.
Read the ISTA and Bausch + Lomb press release on termination of the waiting period
