The FDA has approved a supplemental biologics license application for Xeomin as a first-line treatment for blepharospasm, according to a press release from Merz.
Xeomin (incobotulinumtoxinA) was first approved to treat blepharospasm in 2010.
A randomized, double-blind, placebo-controlled, phase 3 clinical trial of 61 patients showed treated subjects had a –1.2 improvement in blepharospasm severity subscore as measured on the Jankovic rating scale compared to placebo-treated subjects (P = .004).
“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.,” Kevin O’Brien, vice president and U.S. head of neurosciences, Merz, said. “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.”