The Food and Drug Administration (FDA) has approved Xeomin (incobotulinumtoxinA; Merz) as a first-line treatment for blepharospasm in adults.
The approval was based on data from a phase 3 study that included 61 treatment-naïve patients who had a diagnosis of blepharospasm with a baseline Jankovic Rating Scale (JRS) Severity subscore ≥2; JRS is a clinical scale used to measure blepharospasm severity and frequency. The primary outcome measure of the study was the change from baseline in JRS Severity subscore at Week 6.
Results showed that treatment with Xeomin (50 units) was associated with a statistically significant improvement compared with placebo (treatment difference: -1.2; P =.0004). With regard to safety, findings were similar to those seen in previous studies with Xeomin.
“Merz is proud to offer a first-line treatment option for blepharospasm, a devastating condition that has no cure and affects up to 50,000 patients in the US,” said Kevin O’Brien, Vice President and US Head of Neurosciences, Merz.
In addition to blepharospasm, Xeomin is also indicated for chronic sialorrhea, upper limb spasticity, cervical dystonia, and for the temporary improvement in the appearance of glabellar lines associated with corrugator and/or procerus muscle activity.
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