FDA OKs Merz Drug for Involuntary Blinking

Merz logo

Raleigh-based Merz North America has received approval from the U.S. Food and Drug Administration to market a treatment for blepharospasm, or involuntary blinking, in adults.

The treatment, Xeomin, is a botulinum toxin. It is used cosmetically for smoothing frown lines between the eyebrows but is increasingly being used for other indications.

“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 U.S.,” said Kevin O’Brien, vice president and U.S. head of neurosciences for Merz. “This milestone, along with the July 2018 approval of Xeomin for the treatment of chronic sialorrhea (drooling) in adults, reinforces our commitment to providing comprehensive care for patients living with movement disorders.”

The FDA approved Merz’s supplemental Biologics License Application for Xeomin, or incobotulinumtoxinA, based on a Phase 3 clinical trial of 61 patients with blepharospasm. Patients receiving the drug showed statistically significant improvement in severity and frequency of spasms compared to placebo six weeks after injection.

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

Xeomin is proving to be a versatile product for Merz. It was first approved by the FDA in 2010 for treating blepharospasm in patients previously treated with onabotulinumtoxinA, and for cervical dystonia, an involuntary contraction of neck muscles that causes the head to twist or turn to one side. In 2015 it was approved for treating upper limb spasticity.

Most recently, Xeomin was approved by the FDA in July 2018 to treat chronic sialorrhea.

Merz North America headquarters
Merz North America headquarters building in Raleigh. -- Merz photo

Merz North America is a division of privately owned Merz Pharma Group, an international specialty health care company based in Frankfurt, Germany, that is focused on aesthetics and neuroscience products to help patients “live better, feel better and look better.”

Nearly 300 employees of Merz North America celebrated the 110th anniversary of Merz’s founding in 2018 at the company’s offices on Six Forks Road in North Raleigh.

Merz established its North America division in Greensboro in 1995 and kept it there until January 2015, when it consolidated operations at a 60,000 square-foot facility in Raleigh. 

Merz has a direct presence in six countries in the Americas, as well as a network of distribution partners in South and Central America and the Caribbean. The company has facilities in Mesa, Ariz., and Franksville, Wis., as well as affiliate offices in Toronto, Mexico City, Bogotá, São Paolo and Buenos Aires.

In 2017-18 Merz Pharma Group reported about $1.2 billion in global revenues with almost a third coming from North America sales.

Barry Teater, NCBiotech Writer
Tue, 05/14/2019 - 12:08