A Report by the American Academy of Ophthalmology Ophthalmic Technology Assessment Committee Oculoplastics and Orbit Panel: Jurij R. Bilyk, MD,1 Michael T. Yen, MD,2 Elizabeth A. Bradley, MD,3 Edward J. Wladis, MD,4 Louise A. Mawn, MD5
Ophthalmology, © 2018 by the American Academy of Ophthalmology. Click here for free access to the OTA.
Purpose: To review the medical literature on the outcomes and complications of various Food and Drug Administration-approved botulinum toxins for benign essential blepharospasm (BEB) and hemifacial spasm (HFS).
Methods: Literature searches were last conducted in February 2017 in PubMed for articles published in English and in the Cochrane Library database without language limitations; studies published before 2000 were excluded. The combined searches yielded 127 citations. Of these, 13 articles were deemed appropriate for inclusion in this assessment, and the panel methodologist assigned ratings to them according to the level of evidence.
Results: A combined total of 1523 patients (1143 with BEB and 380 with HFS) were included in the 13 studies. Five studies provided level I evidence, 2 studies provided level II evidence, and 6 studies provided level III evidence. Pretarsal injections were more efficacious than preseptal injections (96% vs. 86%, respectively). Pretarsal injections also resulted in a higher response rate on clinical scales (P < 0.05) and a longer duration of maximum response for both HFS and BEB. Patients with HFS require lower overall doses of onabotulinumtoxinA than patients with BEB for a similar duration of effect. Adverse events were dose related, and they occurred more frequently in patients who were given more units.
Conclusions: Level I evidence supports the efficacy of Botox (Allergan Corp., Irvine, CA), Meditoxin, and Xeomin (Merz Pharmaceuticals, Frankfurt am Main, Germany) for the treatment of BEB. Meditoxin and Botox have equivalent effectiveness and incidence of adverse events for BEB and HFS. Dysport (Ipsen Biopharmaceuticals, Inc, Paris, France) seems to have efficacy similar to Botox and Meditoxin for BEB and HFS, but any definitive conclusions from the 2 level II studies in this review are limited by differences in the methodologies used. Higher doses of Botox and Dysport result in more adverse events. Repeated treatments using Botox seem to maintain efficacy for treatment of facial dystonias over a follow-up period of at least 10 years, based on level III evidence.
1 Wills Eye Hospital, Philadelphia, Pennsylvania.
2 Cullen Eye Institute, Baylor College of Medicine, Houston, Texas.
3 Department of Ophthalmology, Mayo Clinic, Rochester, Minnesota.
4 Ophthalmic Plastic Surgery, Lions Eye Institute, Department of Ophthalmology, Albany Medical Center, Albany (Slingerlands), New York.
5 Vanderbilt Eye Institute, Vanderbilt University, Nashville, Tennessee.