{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,5]],"date-time":"2026-11-05T17:33:46Z","timestamp":1793900026537,"version":"4.8.0"},"reference-count":21,"publisher":"MDPI AG","issue":"9","license":[{"start":{"date-parts":[[2025,4,28]],"date-time":"2025-04-28T00:00:00Z","timestamp":1745798400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCM"],"abstract":"<jats:p>Background\/objectives: The efficacy and safety of the XEN45 gel stent implant in patients with glaucoma have been amply demonstrated. XEN63 is a new device that has been developed with a larger bore. This multicenter, observational, retrospective study assessed the efficacy and safety of XEN63 in patients with glaucoma. Methods: Medical records from six participating centers were screened to identify patients meeting the inclusion criteria. The primary outcome was mean IOP at 6 months after surgery. Results: The study included 114 eyes from 102 patients (XEN63 alone: 68 eyes, and XEN63 + Phaco: 46 eyes); 92% of patients had primary open-angle glaucoma. Baseline IOP for all patients was a median of 23.0 mmHg (IQR: 18.5\u201327.5 mmHg), which decreased significantly on day one post-surgery to 7.0 mmHg (IQR: 4.5\u20139.5 mmHg) and gradually stabilized at around 13.5 mmHg (IQR: 10.5\u201316.5 mmHg) by 6 months with no significant differences between groups at 6 months. The number of ocular hypertensive medications (OHMs) reduced significantly from a baseline median of 2.7 \u00b1 1.1 to 0.5 \u00b1 1.0 at 6 months in the entire cohort. The XEN63 alone group showed a significantly lower need for OHMs at 3 and 6 months. The surgical success rate was comparable between the two groups (54.4% vs. 47.8%, p = 0.05, XEN63 alone and XEN63 + Phaco). There was no statistically significant difference in survival outcomes between the XEN63 (0.59, 95% CI: 0.49\u20130.73) and XEN63 + Phaco groups (0.55, 95% CI: 0.42\u20130.72) (p = 0.89). Conclusions: In the largest study with XEN63 to date, the device appears to significantly decrease the IOP and the OHMs. Simultaneous XEN63 implant and phacoemulsification showed similar outcomes compared to XEN63 alone.<\/jats:p>","DOI":"10.3390\/jcm14093036","type":"journal-article","created":{"date-parts":[[2025,4,28]],"date-time":"2025-04-28T09:39:47Z","timestamp":1745833187000},"page":"3036","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["Efficacy and Safety of XEN63 Gel Stent Implant over 6 Months for Treatment of Glaucoma"],"prefix":"10.3390","volume":"14","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6399-3140","authenticated-orcid":false,"given":"Matteo","family":"Sacchi","sequence":"first","affiliation":[{"name":"Department of Medicine, Surgery and Pharmacy, University of Sassari, Viale San Pietro 43, 07100 Sassari, Italy"},{"name":"Ophthalmology Unit, Azienda Ospedaliero-Universitaria di Sassari, 07100 Sassari, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5260-0126","authenticated-orcid":false,"given":"Sara","family":"Giammaria","sequence":"additional","affiliation":[{"name":"IRCCS Fondazione Bietti, 00198 Rome, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gloria","family":"Roberti","sequence":"additional","affiliation":[{"name":"IRCCS Fondazione Bietti, 00198 Rome, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0006-8386-9132","authenticated-orcid":false,"given":"Davide","family":"Tomaselli","sequence":"additional","affiliation":[{"name":"Eye Clinic, San Giuseppe Hospital, IRCCS Multimedica, University of Milan, 20123 Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0005-4790-6031","authenticated-orcid":false,"given":"Gianluca","family":"Monsellato","sequence":"additional","affiliation":[{"name":"Eye Clinic, San Giuseppe Hospital, IRCCS Multimedica, University of Milan, 20123 Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1625-6305","authenticated-orcid":false,"given":"Luca","family":"Agnifili","sequence":"additional","affiliation":[{"name":"Ophthalmology Clinic, Department of Medicine and Aging Sciences, University \u201cG. D\u2019Annunzio\u201d of Chieti-Pescara, 66100 Chieti, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0222-5177","authenticated-orcid":false,"given":"Chiara","family":"Posarelli","sequence":"additional","affiliation":[{"name":"Ophthalmology Unit, Department of Surgery, Medicine, Molecular and Emergency, University of Pisa, 56127 Pisa, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giacomo","family":"Abbruzzese","sequence":"additional","affiliation":[{"name":"SS Cosma e Damiano Hospital, 51017 Pescia, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lorenza","family":"Ronchi","sequence":"additional","affiliation":[{"name":"Ophthalmology Unit, Azienda Ospedaliero-Universitaria di Sassari, 07100 Sassari, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8630-0367","authenticated-orcid":false,"given":"Filippo","family":"Tatti","sequence":"additional","affiliation":[{"name":"Eye Clinic, Department of Surgical Sciences, University of Cagliari, 09124 Cagliari, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stefano","family":"Dore","sequence":"additional","affiliation":[{"name":"Department of Medicine, Surgery and Pharmacy, University of Sassari, Viale San Pietro 43, 07100 Sassari, Italy"},{"name":"Ophthalmology Unit, Azienda Ospedaliero-Universitaria di Sassari, 07100 Sassari, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2617-0289","authenticated-orcid":false,"given":"Giuseppe","family":"Giannaccare","sequence":"additional","affiliation":[{"name":"Eye Clinic, Department of Surgical Sciences, University of Cagliari, 09124 Cagliari, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4036-703X","authenticated-orcid":false,"given":"Paolo","family":"Nucci","sequence":"additional","affiliation":[{"name":"Department of Clinical Sciences and Community Health, University of Milan, 20122 Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3052-2662","authenticated-orcid":false,"given":"Antonio","family":"Pinna","sequence":"additional","affiliation":[{"name":"Department of Medicine, Surgery and Pharmacy, University of Sassari, Viale San Pietro 43, 07100 Sassari, Italy"},{"name":"Ophthalmology Unit, Azienda Ospedaliero-Universitaria di Sassari, 07100 Sassari, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2243-9033","authenticated-orcid":false,"given":"Michele","family":"Figus","sequence":"additional","affiliation":[{"name":"Ophthalmology Unit, Department of Surgery, Medicine, Molecular and Emergency, University of Pisa, 56127 Pisa, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2504-0004","authenticated-orcid":false,"given":"Francesco","family":"Oddone","sequence":"additional","affiliation":[{"name":"IRCCS Fondazione Bietti, 00198 Rome, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2025,4,28]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"1788","DOI":"10.1016\/S0140-6736(23)01289-8","article-title":"Glaucoma: Now and beyond","volume":"402","author":"Jayaram","year":"2023","journal-title":"Lancet"},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"2081","DOI":"10.1016\/j.ophtha.2014.05.013","article-title":"Global prevalence of glaucoma and projections of glaucoma burden through 2040: A systematic review and meta-analysis","volume":"121","author":"Tham","year":"2014","journal-title":"Ophthalmology"},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"271","DOI":"10.7326\/0003-4819-158-4-201302190-00008","article-title":"Comparative effectiveness of treatments for open-angle glaucoma: A systematic review for the U.S. Preventive Services Task Force","volume":"158","author":"Boland","year":"2013","journal-title":"Ann. 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