Posted by Michael Wonder on 14 May 2019
FDA approves broadened indication for Xeomin (incobotulinumtoxinA) as first-line treatment for blepharospasm (involuntary blinking) in adult patients
13 May 2019 - Merz Americas announced today that the U.S. FDA has approved the supplemental biologics license application for Xeomin (incobotulinumtoxinA), broadening its indication to be a first-line treatment of blepharospasm (involuntary blinking) in adult patients.
The approval is based on a Phase 3, randomised, double-blind, placebo-controlled, multi-center trial in a total of 61 treatment-naïve patients who had a diagnosis of blepharospasm with a baseline Jankovic Rating Scale Severity sub-score ≥2.
