ISTA Provides Update On Bepreve

ISTA Pharmaceuticals has presented additional results from Bepreve (bepotastine besilate ophthalmic solution) 1.5% Phase 3 clinical studies. Bepreve is a non-sedating, highly selective antagonist of the histamine (H1) receptor.

Integrated results from two Phase 3 studies demonstrated that Bepreve 1.5% was as effective in suppressing ocular itching in patients with more severe itching as in patients with all grades of ocular itching.

The result was presented in ‘Treatment of Ocular Itching with Bepotastine Besilate Ophthalmic Solution 1.5% for Subjects with More Severe Itching Response in a Conjunctival Allergen Challenge (CAC) Clinical Model of Allergic Conjunctivitis.’

The study shows that a total of 157 patients were enrolled in two 7-week, masked, randomised, placebo-controlled CAC clinical studies (1 single site, 1 multi-site). 113 patients exhibited bilateral ocular itching grades greater than or equal to 3 at screening during study visit 2. Individuals were assessed at 15 minutes, 8 hours, or 16 hours following instillation at study visits spaced two weeks apart during the enrollment period.

The difference in mean itching grades (placebo-active) for the more severely affected subjects was within plus or minus 0.1 unit of the differences for the entire intent-to-treat (ITT) population.

Bepreve was approved by the FDA for the treatment of ocular itching associated with allergic conjunctivitis. Bepotastine has been approved in Japan for systemic use in the treatment of allergic rhinitis since 2000 and urticaria/pruritus since 2002. It is marketed in Japan by Mitsubishi Tanabe Pharma under the brand name Talion.