Officials with the FDA have expanded the indication for Merz Americas’ incobotulinumtoxinA (Xeomin) to include first-line treatment of blepharospasm in adult patients, through the approval of its supplemental Biologics License Application (sBLA).
Blepharospasm causes muscles around the eyes to contract involuntarily. Patients suffering from blepharospasm can experience symptoms that include excessive blinking, light sensitivity, dry eyes, eye irritation and watering eyes, and symptoms may worsen over time.
IncobotulinumtoxinA is a botulinum toxin type A that is injected into muscles or salivary glands.
“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 US,”1 said Kevin O’Brien, Vice President and US Head of Neurosciences, Merz., in a prepared statement.
The milestone, O’Brien said, reinforces Merz’ commitment to providing comprehensive care for patients with movement disorders.
IncobotulinumtoxinA was first approved by the FDA in 2010, and its use was subsequently expanded in 2015 and 2018. In addition to first-line treatment of blepharospasm, the drug is indicated for adult patients with cervical dystonia, upper limb spasticity, and chronic sialorrhea, or excessive drooling.
The new sBLA approval is based on a Phase 3, randomized, double-blind, placebo-controlled, multicenter trial in 61 treatment-naïve patients who had a diagnosis of blepharospasm with a baseline Jankovic Rating Scale (JRS) Severity subscore ≥2, according to Merz. JRS is the most commonly used clinical scale to measure severity and frequency of the condition. 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 6 after the incobotulinumtoxinA 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 the drug.
incobotulinumtoxinA may cause serious adverse effects that include problems with swallowing, speaking or breathing, as well as spread to toxin effects. The most common adverse effects in patients with blepharospasm include drooping of the eyelid, dry eye, vision problems, and dry mouth.
FDA Approves Broadened Indication for XEOMIN® (IncobotulinumtoxinA) as First-Line Treatment for Blepharospasm (Involuntary Blinking) in Adult Patients [news release]. Raleigh, NC; May 13, 2019: Merz website. https://www.merzusa.com/news/fda-approves-broadened-indication-for-xeomin-incobotulinumtoxina-as-first-line-treatment-for-blepharospasm-involuntary-blinking-in-adult-patients/. Accessed May 14, 2019.