XEOMIN® Efficacy | Blepharospasm

Adults With Blepharospasm

In treatment–naïve patients*

XEOMIN Demonstrated Significant Improvements in the Jankovic Rating Scale (JRS) Severity Subscore vs Placebo at Week 61,2

  • XEOMIN 50 U demonstrated significant improvements when compared with placebo at week 6 (P=0.0004)1,2
Change from baseline JRS severity sub score. Pinch to zoom

*Patients were defined as treatment–naïve if at least 12 months had passed since their last botulinum toxin treatment for blepharospasm.
†XEOMIN 25 Units was not statistically significant when compared with placebo at week 6 (P=0.1452)1,2

In patients pretreated with Botox®

XEOMIN Significantly Reduced Mean Symptom Severity as Measured by JRS Severity Subscore3

Efficacy of XEOMIN® vs placebo Pinch to zoom

‡Missing values replaced with last observation carried forward.

Noninferiority study: XEOMIN vs active comparator (Botox)

XEOMIN Was Proven Noninferior to Botox

  • XEOMIN and Botox were similarly effective in treating blepharospasm as measured by the JRS sum score at week 34
Efficacy of XEOMIN® vs active comparator of Botox® Pinch to zoom

§P<0.0001

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

Noninferiority study: XEOMIN vs active comparator (Botox)

XEOMIN and Botox Had Similar Onset, Waning, and Duration of Effect5

Onset, waning, and duration of effect between XEOMIN® and Botox. Pinch to zoom

‖Patient–reported outcome: onset and waning of effect were subjectively estimated by the patient at control and end of study visits.
¶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, Althaus M, Pagan F. Long-term safety and efficacy of incobotulinumtoxinA for the treatment of blepharospasm in botulinum toxin–naïve subjects: results of a phase III study. Poster presented at: Toxins; January 16–19, 2019; Copenhagen, Denmark.
  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. Roggenkämper P, Jost WH, Bihari K, Comes G, Grafe S; for the NT 201 Blepharospasm Study Team. Efficacy and safety of a new botulinum toxin type A free of complexing proteins in the treatment of blepharospasm. J Neural Transm (Vienna). 2006;113(3):303–312.
  5. Data on file. Raleigh, NC: Merz North America, Inc.; 2019.