7:30AM ISTA Pharm reports 'positive', topline results from its Phase 2 clinical trial of BEPOSONE nasal spray for the treatment of symptoms associated with seasonal allergic rhinitis (ISTA) 9.05 : According to 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. These improvements were seen as early as Day 1 of therapy and were sustained through the two-week treatment period. Statistically significant improvement was also seen 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. "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. BEPOSONE and BEPOMAX represent exciting potential expansions of our prescription allergy product line, currently focused on BEPREVE (bepotastine besilate ophthalmic solution) 1.5% for the treatment of ocular itching associated with allergic conjunctivitis."
surf's up......crikey
