{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,20]],"date-time":"2026-02-20T17:01:59Z","timestamp":1771606919652,"version":"3.50.1"},"reference-count":27,"publisher":"MDPI AG","issue":"2","license":[{"start":{"date-parts":[[2026,2,20]],"date-time":"2026-02-20T00:00:00Z","timestamp":1771545600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Teijin Pharma Limited"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Toxins"],"abstract":"<jats:p>This open-label, uncontrolled, single-arm, multicenter, phase 3 study evaluated the efficacy and safety of incobotulinumtoxinA in Japanese patients with blepharospasm. Eligible patients received incobotulinumtoxinA injections at fixed doses (50, 75, or 100 units [U] for those who had previously received botulinum toxin treatment; 50 U for treatment-na\u00efve patients), followed by flexible doses up to 100 U for 48 weeks, with at least 6-week intervals. In total, 29 Japanese patients were enrolled (26 [89.7%] women, mean age 64.6 years, mean baseline Jankovic Rating Scale [JRS] severity score 3.24). The primary endpoint, the least squares mean of change in JRS severity scores from baseline to 6 weeks after the first injection, was \u22122.08 (95% confidence interval: \u22122.49, \u22121.66), meeting the prespecified efficacy criteria. The secondary endpoint results (JRS severity, frequency, and total scores for 48 weeks; Blepharospasm Disability Index; Patient Evaluation of Global Response; and fast blinking test) supported the efficacy of repeated incobotulinumtoxinA injections. Adverse events (AEs) occurred in 19 (65.5%) patients, with eyelid ptosis being the most common treatment-related AE (4 [13.8%] patients). No severe or serious AEs were reported. IncobotulinumtoxinA demonstrated sustained efficacy in Japanese patients with blepharospasm, without new safety concerns. (Japan Registry of Clinical Trials identifier, jRCT2031230711)<\/jats:p>","DOI":"10.3390\/toxins18020109","type":"journal-article","created":{"date-parts":[[2026,2,20]],"date-time":"2026-02-20T15:57:11Z","timestamp":1771603031000},"page":"109","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Efficacy and Safety of IncobotulinumtoxinA for the Treatment of Blepharospasm: A Multicenter, Phase 3 Study in Japan"],"prefix":"10.3390","volume":"18","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9016-8015","authenticated-orcid":false,"given":"Toshiaki","family":"Goseki","sequence":"first","affiliation":[{"name":"Department of Ophthalmology, International University of Health and Welfare, Atami Hospital, Atami 413-0012, Japan"},{"name":"Department of Ophthalmology, Kitasato University, Sagamihara 252-0375, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yoshihito","family":"Mochizuki","sequence":"additional","affiliation":[{"name":"Department of Ophthalmology, Hyogo Medical University, Nishinomiya 663-8501, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Akiko","family":"Masuda","sequence":"additional","affiliation":[{"name":"Department of Ophthalmology, Hyogo Medical University, Nishinomiya 663-8501, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Motohiro","family":"Kiyosawa","sequence":"additional","affiliation":[{"name":"Jiyugaoka Kiyosawa Eye Clinic, Tokyo 152-0035, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6434-9541","authenticated-orcid":false,"given":"Ryosuke","family":"Miyamoto","sequence":"additional","affiliation":[{"name":"Department of Neurology, Tokushima University Hospital, Tokushima 770-8503, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Masato","family":"Wakakura","sequence":"additional","affiliation":[{"name":"Department of Ophthalmology, Inouye Eye Hospital, Tokyo 101-0062, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Akiko","family":"Yamagami","sequence":"additional","affiliation":[{"name":"Department of Ophthalmology, Inouye Eye Hospital, Tokyo 101-0062, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2930-5003","authenticated-orcid":false,"given":"Yohei","family":"Mukai","sequence":"additional","affiliation":[{"name":"Department of Neurology, National Center of Neurology and Psychiatry, Tokyo 187-8551, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2795-8430","authenticated-orcid":false,"given":"Akihiro","family":"Shinkai","sequence":"additional","affiliation":[{"name":"Department of Ophthalmology, Faculty of Medicine, Graduate School of Medicine, Hokkaido University, Sapporo 060-8648, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mutsumi","family":"Iijima","sequence":"additional","affiliation":[{"name":"Department of Neurology, School of Medicine, Tokyo Women\u2019s Medical University, Tokyo 162-8666, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0008-1137-870X","authenticated-orcid":false,"given":"Kousuke","family":"Baba","sequence":"additional","affiliation":[{"name":"Department of Neurology, Graduate School of Medicine, The University of Osaka, Osaka 565-0871, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hideki","family":"Chuman","sequence":"additional","affiliation":[{"name":"Department of Ophthalmology, Faculty of Medicine, University of Miyazaki, Miyazaki 889-1692, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Masahiro","family":"Hashizuka","sequence":"additional","affiliation":[{"name":"Clinical Development Department, Teijin Pharma Limited, Tokyo 100-8585, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shohei","family":"Tateishi","sequence":"additional","affiliation":[{"name":"Clinical Development Control Department, Teijin Pharma Limited, Tokyo 100-8585, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Akiko","family":"Kimura","sequence":"additional","affiliation":[{"name":"Kind Eye Clinic, Kobe 650-0022, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1968","published-online":{"date-parts":[[2026,2,20]]},"reference":[{"key":"ref_1","unstructured":"Titi-Lartey, O.A., and Patel, B.C. 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