Safety and Effectiveness of a Gel Stent in Refractory Glaucoma in China: Real-World Evidence at 12 Months

Purpose

The XEN gel stent (XEN Glaucoma Treatment System®; AbbVie Inc., North Chicago, IL, USA) is a minimally invasive bleb-forming device implanted ab-interno to lower intraocular pressure. The gel stent is approved to treat refractory glaucoma in China since 2020, based on interim real-world study data from patients at Hainan Boao Super Hospital. Final study data on the gel stent's effectiveness and safety in those patients are presented. Patients and methods: The single-center, single-arm, open-label, phase 3b Hainan study collected data from Chinese patients with refractory glaucoma (ie, failed surgical treatment or primary open-angle/pseudoexfoliative/pigmentary glaucoma unresponsive to medical therapy) who underwent ab-interno gel stent implantation. This study was designed for both retrospective and prospective collection of real-world data. Primary effectiveness outcome: Proportion of study eyes at 12 months achieving ≥20% intraocular pressure (IOP) reduction from baseline without increasing the number of IOP-lowering medications and without secondary surgical intervention. Secondary effectiveness outcomes: mean IOP and mean number of IOP-lowering medications used over time. Safety outcomes: intraoperative complications and postoperative treatment-emergent adverse events (TEAEs), postoperative needling, and ophthalmic safety assessments.