Clinical efficacy and tolerability of Xeomin in the treatment of blepharospasm.

BACKGROUND AND PURPOSE

Blepharospasm is classified as a focal dystonia, and botulinum toxin type A (BoNT/A) has been shown to be a highly effective and well-tolerated symptomatic treatment. Xeomin, the latest addition to BoNT/A preparations, is a purified, freeze-dried BoNT/A that is free from complexing proteins.

METHODS AND RESULTS

In a double-blind, parallel-group, multicentre study, 300 patients with blepharospasm received either Xeomin or Botox 15-80 U (J Neural Transm 2006; 113: 303). Both treatments produced statistically significant improvements from baseline in the Jankovic Rating Scale at week 3 (primary efficacy variable; Xeomin: -2.90; Botox: -2.67; P < 0.0001 from baseline for both), with the difference between treatments (-0.23) indicating that Xeomin was clinically non-inferior to Botox. No significant differences were found between Xeomin and Botox for all secondary variables. There were no clinically relevant differences between Xeomin and Botox in safety parameters, with 40 of 148 patients (27.0%) treated with Xeomin reporting adverse events versus 45 of 155 patients (29.0%) treated with Botox. The most common adverse event was ptosis (6.1% Xeomin and 4.5% Botox).

CONCLUSION

Clinical evidence to date suggests that Xeomin is an effective treatment for blepharospasm that does not differ from Botox in terms of its potency, duration of effect or adverse reaction profile.