ISTA Pharma Reports Positive Results From Phase 2 Trial Of BEPOSONE Nasal Spray

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5/1/2012 7:55 AM ET

ISTA Pharmaceuticals Inc. (ISTA: Quote) announced positive results from its Phase 2 randomized, placebo-controlled, parallel-group environmental clinical study of BEPOSONE nasal spray for the treatment of symptoms associated with seasonal allergic rhinitis, the inflammation of the nasal passages caused by allergies. As per the trial findings, BEPOSONE nasal spray showed highly statistically significant improvements compared to placebo in patients' nasal symptoms following exposure to one of the most potent seasonal allergy triggers, Mountain Cedar pollen.

Also, statistically significant improvement was witnessed for BEPOSONE within 15 minutes after dosing in a small subgroup of subjects who frequently evaluated their nasal symptoms for 4 hours after their first nasal spray dose. Further, safety data demonstrated BEPOSONE was well-tolerated as a nasal spray, with an adverse event profile similar to placebo and generally consistent with those observed with bepotastine besilate dosed as a nasal spray in prior clinical trials and with other antihistamine nasal sprays, the company said.

The Phase 2 trial was a randomized, multi-center, double-masked, placebo-controlled, parallel-group environmental trial to evaluate the safety and efficacy of BEPOSONE, dosed twice daily, in patients presenting with allergic rhinitis caused by Mountain Cedar pollen.

Commenting on the Phase 2 study, Timothy McNamara, Vice President of Clinical Research and Medical Affairs of ISTA Pharmaceuticals stated, "The study was intended to provide key information for making strategic decisions on appropriate Phase 3 study designs with our bepotastine besilate nasal spray franchise. Based on these results and the positive Phase 2 results from our single-agent antihistamine nasal spray of bepotastine besilate, BEPOMAX™, which were reported last year, we expect to complete some additional Phase 2 studies ahead of our Phase 3 pivotal program covering both products, slated to begin in 2013."

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