Anne Barmettler, MD, Director of Ophthalmic Plastic and Reconstructive Surgery and Principal Investigator at Montefiore Einstein and Professor of Ophthalmology and Visual Sciences at Albert Einstein College of Medicine, is spearheading a clinical study evaluating the safety and efficacy of daxibotulinumtoxinA-lanm (Daxxify™) in patients with benign essential blepharospasm (BEB) and hemifacial spasm (HFS), two neurologic facial movement disorders that can significantly impair quality of life. By directly comparing Daxxify™ with patients’ prior botulinum toxin treatment histories, the study aims to generate practical clinical evidence to inform treatment strategies for these conditions.

Botulinum neurotoxin injections have transformed the management of BEB and HFS and are widely used as the standard of care; however, the need for frequent repeat injections remains a limitation for many patients. This study is designed to assess whether treatment with Daxxify™, a peptide-formulated, longer-acting neuromodulator, demonstrates clinically meaningful benefit compared with patients’ prior treatment histories using onabotulinumtoxinA (Botox®).

The trial employs a single-arm, crossover design conducted at Montefiore Einstein, in which each participant serves as their own historical control. Patients with a documented history of treatment with Botox® for BEB or HFS are crossed over to receive Daxxify™ using a 2:1 unit conversion ratio, enabling within-subject comparison of treatment response. Participant selection and longitudinal data collection are supported through Montefiore Einstein’s electronic medical record system, ensuring comprehensive clinical documentation and real-world clinical insight. The primary objectives are to evaluate treatment response and to determine the percentage of patients achieving a clinical response. Therapeutic response, the primary outcome measure, is assessed as the difference between baseline and peak efficacy scores using the Jankovic Rating Scale (JRS) following treatment.

Post-treatment effects observed one to two weeks later are categorized based on clinical response, including complete relief of spasms, partial relief to a tolerable level, mild to moderate ocular irritation or ptosis. Overall response is further characterized by duration of symptom control and the interval before a repeat injection is required. Adverse events are closely monitored throughout the study, and treatment is discontinued in any patient for whom side effects outweigh potential clinical benefit.

Benign essential blepharospasm and hemifacial spasm are characterized by involuntary, repetitive contractions of the orbicularis oculi (eye muscle) and other facial muscles. In BEB, spasms typically involve bilateral eyelid closure, while HFS often presents unilaterally and may extend to other muscles of facial expression. In both conditions, involuntary muscle contractions can lead to intermittent or sustained eyelid closure, interfering with vision, daily activities and overall quality of life. Botulinum toxin works by inhibiting the release of acetylcholine at the neuromuscular junction, resulting in reduced muscle contraction.

This trial reflects Montefiore Einstein’s ongoing commitment to clinical investigation and to advancing therapeutic options for conditions that affect vision, function and quality of life.

For information about enrolling a patient into this clinical trial, please call 718-920-2020.

ClinicalTrials.gov ID: NCT06195241