17 May 2019 - - The US Food and Drug Administration 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, German pharmaceutical company Merz Pharma's US-based Merz Americas business said.

Blepharospasm causes muscles around the eyes to contract involuntarily.

Patients suffering from blepharospasm can experience symptoms including excessive blinking, light sensitivity, dry eyes, eye irritation and watering eyes, and symptoms may worsen over time.

The approval is based on a Phase 3, randomized, 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 subscore ≥2.

JRS is the most commonly used clinical scale to measure severity and frequency of blepharospasm. Patients were defined as treatment-naïve 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 six after the Xeomin injection.

The 50 unit treatment group demonstrated statistically significant improvement compared to placebo, with a difference of -1.2 (p=0.0004). The safety findings were similar to previous studies and in line with the known safety profile of Xeomin.

Xeomin was first approved by the FDA in 2010 for the 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, Xeomin was approved by the FDA in July 2018 to treat chronic sialorrhea (excessive drooling) in adult patients.

Merz has a direct presence in six countries in the Americas, as well as a network of selected professional distribution partners in South and Central America and the Caribbean.

Merz in the Americas is headquartered in Raleigh, North Carolina, and has facilities in Mesa, Arizona, Franksville, Wisconsin as well as affiliate offices in Toronto, Canada, Mexico City, Bogotá, Colombia, São Paolo, Brazil and Buenos Aires, Argentina.