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. Results: Fifty-nine patients were enrolled that composed the effectiveness (n=59 eyes) and safety (n=62 eyes) populations. Among the 59 study eyes, 53 (89.8%) completed the 12-month visit. Mean IOP decreased from 23.7 mmHg on 3.3 IOP-lowering medications at baseline (47.5% of patients requiring ≥4 medications; 59.3% with prior glaucoma surgery) to 17.4 mmHg on 1.0 IOP-lowering medication at month 12. 49.0% (95% CI: 34.8-63.4) of the study eyes achieved the primary effectiveness outcome based on observed data. Among study eyes with baseline IOP ≥20 mmHg (n=31/59; 52.5%), IOP decreased from 30.4 mmHg on 3.4 medications (baseline) to 17.2 mmHg on 0.6 medications (month 12), and 17/28 (60.7%) achieved the primary outcome. No intraoperative complications or ocular TEAEs leading to study discontinuation were reported. Excluding expected inflammatory TEAEs following filtration surgery, IOP decreased (8.1%) and IOP increased (33.9%) were the most common TEAEs ≤7 and >7 days after surgery, respectively. Conclusions: The gel stent effectively lowered IOP and IOP-lowering medication burden in Chinese patients with refractory glaucoma, with no new unexpected safety findings, supporting its use as a minimally invasive bleb-forming surgical option in this population. Future considerations may include larger, prospective, comparative studies.