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Analysis of integrated Phase III trials supports the efficacy of bepotastine besilate ophthalmic solution (BBOS) for treatment of ocular itching associated with allergic conjunctivitis.
Results of two Phase III, double-blind, placebo-controlled trials suggest that BBOS gives greater relief from ocular itching associated with allergic conjunctivitis than placebo three minutes after application and that its superior effects last for more than eight hours.
Such ocular itching was induced by conjunctival allergen challenge (CAC). The studies compared BBOC 1.5% with placebo in 157 patients.
The difference in efficacy of BBOS solution and placebo between three minutes and eight hours reached significance, with p<0.0001.
Post-hoc analyses also demonstrated superior activity of BBOS, over placebo, in patients with “more severe itching response at screening” and in patients with “complete or near complete resolution of CAC-induced itching.
Lead author E Meier and co-authors wrote in the journal Allergy Asthma Proceedings: “BBOS 1.5% is safe and effective in the treatment of ocular itching associated with allergic conjunctivitis within three minutes of a CAC and with a sustained duration of action of at least eight hours.”