Medication Monitor



Generic Name (Trade Name—Company)
Notes
June 12, 2019

Incobotulinumtoxin A

(Xeomin—Merz)
FDA approves broadened indication for blepharospasm in adults

Merz Americas announced FDA approval of a new indication for incobotulinumtoxinA as first-line treatment of blepharospasm (involuntary blinking) in adult patients.

Blepharospasm causes muscles around the eyes to contract involuntarily. Patients can experience symptoms including excessive blinking, light sensitivity, dry eyes, and eye irritation and watering eyes, and symptoms may worsen over time.

Approval for this indication was based on a Phase III, randomized, double-blind, placebo-controlled, multicenter trial in 61 treatment-naive patients who had a diagnosis of blepharospasm with a baseline Jankovic Rating Scale (JRS) Severity subscore of 2 or higher. JRS is the most commonly used clinical scale to measure severity and frequency of blepharospasm. Patients were defined as treatment-naive if at least 12 months had passed since their last toxin treatment.

The primary efficacy endpoint was the change from baseline in JRS Severity subscore determined at week 6 after the injection. The 50-unit treatment group demonstrated statistically significant improvement compared with placebo. The safety findings were similar to previous studies and in line with the product's known safety profile.

IncobotulinumtoxinA was first approved by FDA in 2010 for treatment of blepharospasm (previously treated with onabotulinumtoxinA) and cervical dystonia in adult patients and later in 2015 for upper limb spasticity in adult patients. Most recently, the agent gained a new approval in July 2018 to treat chronic sialorrhea (excessive drooling) in adult patients.