Efficacy and Safety of IncobotulinumtoxinA for the Treatment of Blepharospasm: A Multicenter, Phase 3 Study in Japan.

ABSTRACT: This open-label, uncontrolled, single-arm, multicenter, phase 3 study evaluated the efficacy and safety of incobotulinumtoxinA in Japanese patients with blepharospasm. Eligible patients received incobotulinumtoxinA injections at fixed doses (50, 75, or 100 units [U] for those who had previously received botulinum toxin treatment; 50 U for treatment-naïve patients), followed by flexible doses up to 100 U for 48 weeks, with at least 6-week intervals. In total, 29 Japanese patients were enrolled (26 [89.7%] women, mean age 64.6 years, mean baseline Jankovic Rating Scale [JRS] severity score 3.24). The primary endpoint, the least squares mean of change in JRS severity scores from baseline to 6 weeks after the first injection, was -2.08 (95% confidence interval: -2.49, -1.66), meeting the presp

SUBMITTER: Goseki T 

PROVIDER: S-EPMC12945157 | biostudies-literature | 2026 Feb

REPOSITORIES: biostudies-literature