XEOMIN for Blepharospasm

“When XEOMIN came out, it helped me. I can keep my eyes open right now; before I had no control… to have to keep trying to keep my eyes open was exhausting. Now I am in control.”
Dona, 59, blepharospasm patient

Reduces severity of disease symptoms, including involuntary eye closure

XEOMIN® (incobotulinumtoxinA) is indicated for the treatment of adults with blepharospasm with onabotulinumtoxinA (Botox®) prior treatment.1

Proven effective in the treatment of blepharospasm

Efficacy vs placebo

XEOMIN demonstrated significant improvements in the Jankovic Rating Scale (JRS) Severity Subscore at week 6 compared with baseline and placebo.2*

Studied in nearly 400 patients with blepharospasm in clinical trials worldwide.3

Nearly all patients (99%) were pretreated with another neurotoxin therapy as per the indication for XEOMIN in the treatment of blepharospasm.3

Study design

Phase 3, multicenter, double-blind study in which 109 patients (ITT population) were randomized 2:1 to receive a single treatment with XEOMIN (n=75) or placebo (n=34). Male and female patients 18–80 years of age were eligible if they had bilateral benign essential blepharospasm previously treated with Botox, a JRS Severity Subscore ≥2, and at least 10 weeks had passed since their previous administration of onabotulinumtoxinA. Each patient in the XEOMIN group received a dose of XEOMIN that was similar to their most recent onabotulinumtoxinA injection sessions prior to study entry. The mean dose of XEOMIN was approximately 33 units per eye. Change in JRS Severity Subscore from baseline was the primary efficacy endpoint.2


*Missing values replaced with last observation carried forward.

Patient population

Patients with any significant neuromuscular disease that might interfere with the study were excluded from enrollment. Patients were randomized (2:1) to receive a single administration of XEOMIN (n=75) or placebo (n=34). The mean age of the study patients was 62 years, and 65% of the patients were women.

Methods

Each patient in the XEOMIN group received a XEOMIN treatment (dose, volume, dilution, and injection sites per muscle) that was similar to the most recent onabotulinumtoxinA injection sessions prior to study entry. The highest dose permitted in this study was 50 units per eye; the mean XEOMIN dose was 33 units per eye. Patients were assessed during clinic visits at weeks 3 and 6, and then by telephone or at clinic visits every 2 weeks up to week 20.1

Results

The study was completed by 94% of study patients. Approximately one-third of patients had other dystonic phenomena; in all but 1% this was limited to facial, cervical, perioral, and mandibular muscles. No patients discontinued the study prematurely due to adverse events.1

The primary efficacy endpoint was the change in JRS Severity Subscore from baseline to week 6 post-injection, in the ITT population, with missing values replaced by the patient’s most recent value (i.e., last observation carried forward). In the ITT population, the difference between the XEOMIN group and the placebo group in the change of the JRS Severity Subscore from baseline to week 6 was -1.0 (95% CI -1.4; -0.5) points. 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.

Efficacy vs active comparator (Botox)

XEOMIN and Botox were similarly effective in treating the symptoms of blepharospasm as measured by the JRS Sum Score at week 3. 4

Study design

A randomized, double-blind, multicenter trial in subjects previously treated with onabotulinumtoxinA (Botox). The mean total doses of study medication injected were similar in the 2 groups (XEOMIN: 39.6 units, SD: 13.3 units; Botox: 40.8 units, SD: 14.2 units).4 Dose used was equivalent to the last 2 treatments with Botox (maximum 35 U/eye).4

References

  1. XEOMIN® [package insert]. Raleigh, NC: Merz North America, Inc; 2015.
  2. 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.
  3. Data on file. Raleigh, NC: Merz North America, Inc.
  4. Roggenkämper 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.