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XEOMIN® Efficacy - Blepharospasm

Adults With Blepharospasm

Disease
Overview
Clinical
Trials
Efficacy Safety Dosing

Proven Efficacy in Treatment-Naïve Adults with Blepharospasm

XEOMIN® demonstrated significant improvements in the primary endpoint, the Jankovic Rating Scale (JRS) severity subscore at week 6 compared with placebo1,2

XEOMIN 50 units demonstrated significant improvements when compared with placebo at week 6 (P=0.0004)1,2

Significant reductions from baseline in JRS severity subscore vs placebo1,2

*XEOMIN 25 units was not statistically significant when compared with placebo at week 6 (P=0.1452)1,2

Proven Efficacy in Adults with Blepharospasm Pretreated with Botox®

XEOMIN demonstrated significant improvements in the Jankovic Rating Scale (JRS) Severity Subscore at week 6 compared with baseline and placebo3†

Efficacy of XEOMIN vs placebo

*Missing values replaced with last observation carried forward

Comparison of the XEOMIN group with the placebo group was statistically significant at P<0.001. Examination of age and gender subgroups did not identify substantial differences in response to XEOMIN among these subgroups. There were too few African-American patients to assess efficacy in that population.2

Proven Efficacy in XEOMIN vs Active Comparator (Botox) in Adults with Blepharospasm

XEOMIN efficacy proven noninferior to the active comparator (Botox) in adults with blepharospasm

Efficacy of XEOMIN vs active comparator of Botox®

The potency units of XEOMIN are specific to the preparation and assay method used and are not interchangeable with other preparations of botulinum toxin products. Therefore, Units of biological activity of XEOMIN cannot be compared to or converted into Units of any other botulinum toxin products.

XEOMIN and Botox had similar durations of effect in adults with blepharospasm4

§Patient-reported outcome: onset and waning of effect were subjectively estimated by the patient at control and end of study visits.

In this non-inferiority study, duration of effect was calculated based on the time between the initial injection and the end of study visit (when the subject and the investigator agreed that a new injection was needed).

The duration of effect in patients with Blepharospasm was comparable between XEOMIN and Botox4

References

  1. Mitsikostas DD, Dekundy A, Sternberg K, Pagan F. Safety and Efficacy of IncobotulinumtoxinA for the Treatment of Blepharospasm in Botulinum Toxin-Naïve Subjects. Neurology. 2019;92(suppl 15):S28.005
  2. XEOMIN® [Package insert]. Raleigh, NC: Merz Pharmaceuticals, LLC; 2019.
  3. Jankovic J, Comella C, Hanschmann A, Grafe S. Efficacy and safety of incobotulinumtoxinA (NT 201, Xeomin) in the treatment of blepharospasm–a randomized trial. Mov Disord. 2011;26(8):1521-1528.
  4. Roggenkamper P, Jost WH, Bihari K, Comes G, Grafe S. Efficacy and safety of a new botulinum toxin type A free of complexing proteins in the treatment of blepharospasm. J Neural Transm. 2006;113(3):303-312.