FDA Approves Xeomin® as First-Line Treatment for Focal Eye Dystonia

The US Food & Drug Administration (FDA) has approved the use of the botulinum neurotoxin Xeomin® (incobotulinumtoxinA) as a first-line treatment of blepharospasm in adults, as announced in a press release from Merz.

Blepharospasm is a focal dystonia that causes muscles around the eyes to contract involuntarily. Individuals with blepharospasm may experience excessive blinking, light sensitivity, dry eyes, eye irritation and watering eyes.

The approval is based on a Phase 3, randomized, double-blind, placebo-controlled, multi-center trial in patients who had a diagnosis of blepharospasm with a baseline clinical scale to measure severity and frequency of blepharospasm.

Xeomin® was first approved by the FDA in 2010 for the treatment of blepharospasm in adults previously treated with onabotulinumtoxinA, and for the treatment of cervical dystonia. Xeomin® is used off-label to treat other focal dystonias. Xeomin® is additionally approved for upper limb spasticity and excessive drooling (chronic sialorrhea).

Click here for more information about botulinum neurotoxin therapy for dystonia.