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Data on Xeomin® (incobotulinumtoxinA) in the Treatment of Blepharospasm to be Presented at the 115th Annual Meeting of the American Academy of Ophthalmology
Date:10/25/2011

between 18 and 80 years of age at 34 sites in the U.S. and Canada, from October 2006 to May 2008. Eligible patients (n=109) were randomized in a 2:1 ratio to receive XEOMIN or placebo and were followed up to 20 weeks. The selection of doses, dilution, volume and injection sites for treatment was based on the last two Botox® treatments (+/- 10%) prior to the start of the study. Up to 50 Units per eye was allowed.

At each visit, the severity and frequency of blepharospasm symptoms were assessed by the Jankovic Rating Scale (JRS), and the Blepharospasm Disability Index (BSDI) was used to evaluate the effect of XEOMIN on patients' functional impairment. The BSDI evaluates six specific activity items, including watching TV, shopping, walking, reading, driving a vehicle and doing everyday activities. In addition, JRS scores were determined by daily patient self-assessments.

A significant difference was observed in the primary efficacy variable (change in JRS severity subscore rated by an independent rater six weeks following treatment), favoring XEOMIN by 1.0 point (P<.001). No patients discontinued the study prematurely because of insufficient treatment efficacy or adverse events.

All patients who completed the placebo-controlled trial (n=102) were eligible to enter the OLEX, which involved repeat treatment with XEOMIN (up to five treatment sessions) over a period of up to 48 weeks. Investigators determined dosing (up to 50 Units per eye) and frequency of injections, with at least six weeks between sessions.

About XEOMINIn nature, Clostridium botulinum produces botulinum toxin in association with ancillary accessory proteins. Manufacturers utilize this naturally occurring protein complex to produce therapeutic botulinum toxin products. XEOMIN (incobotulinumtoxinA) is manufactured using a proprietary process that isolates the therapeutic component and removes accessory proteins.

More than 250,000 patients have be
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SOURCE Merz Pharmaceuticals
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1. FDA Approves Merz Pharmaceuticals Xeomin® (incobotulinumtoxinA) for the Treatment of Cervical Dystonia and Blepharospasm
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