Efficacy and Safety Study of Botulinum Toxin Type A Against Placebo to Treat Abnormal Contraction or Twitch of the Eyelid

Inclusion Criteria:

• Male or female out-patients age ≥ 18 and ≤ 80 years.

• A clinical diagnosis of bilateral BEB characterized by spontaneous, spasmodic,intermittent or persistent involuntary contractions of orbicular oculi muscles.

• A need for injection of BTX defined as a Jankovic Rating Scale [JRS] severity subscore ≥ 2.

• Treatment-naïve subject defined as at least 12 months without BTX of any serotype forthe treatment of BEB before administration of IP.

Exclusion Criteria:

• Subject with any previous unsuccessful treatment with BTX of any serotype for thetreatment of BEB.

• Atypical variant of BEB (e.g., apraxia of the eyelid opening) caused by inhibition oflevator palpebrae muscle.

• Neuroleptic-induced blepharospasm.

• Myotomy or denervation surgery in the affected muscles (e.g., peripheral denervation,spinal cord stimulation) and surgery in the upper face.

• Generalized disorders of muscles activity (e.g., myasthenia gravis in particularocularis, Lambert-Eaton-Syndrome, amyotrophic lateral sclerosis) or any othersignificant neuromuscular dysfunction which might interfere with the study.