A Prospective Evaluation of the 2-Year Efficacy and Safety of INTERCIL: A Novel Uveal Spacer for Open-Angle Glaucoma.

INTRODUCTION: Intraocular pressure (IOP) reduction is the most commonly therapeutically modifiable risk factor in glaucoma. Minimally invasive glaucoma surgeries are generally considered safe but ineffective, constrained by physiological pressure. Invasive bleb-forming filtration surgeries are effective, but associated with high risk and high rates of failure. Technologies utilizing uveoscleral rely on creation of a cyclodialysis cleft. This study evaluated a novel supraciliary uveal spacer (INTERCIL®) designed to enhance uveoscleral outflow, avoiding anterior and posterior chamber entry or bleb formation. METHODS: SAFARI 3, a prospective, single-center, single-arm study included adults with mild-to-moderate glaucoma (Shaffer grade 1-4), uncontrolled on 1-4 medications (baseline IOP 21-35 mmHg). Patients underwent standalone ab externo implantation of INTERCIL®. The primary endpoint was mean change in medicated IOP at 24 months. Secondary outcomes included medication reduction, success rates (IOP ≤ 18 mmHg with ≥ 20% reduction), safety, and quality of life. RESULTS: Twenty-nine patients with primary open-angle glaucoma (POAG) were analyzed (mean age 65.9 years; baseline IOP 23.4 ± 1.9 mmHg; medications 1.9 ± 0.9). At 24 months (n = 19), mean IOP decreased to 14.4 ± 3.1 mmHg (39% reduction); medication use decreased to 0.4 ± 0.8 (83% reduction), with 73.7% medication-free. Complete and qualified success rates were 74% and 95%, respectively. All patients achieved ≥ 20% IOP reduction by 12 and 24 months; 94.7% had IOP between 6 and 18 mmHg at 24 months. Adverse events were mild to moderate in severity. One event of inadvertent anterior chamber entry with migration affected one patient. Six cases of cataract, not deemed device- or procedure-related, were reported; causality cannot be excluded, but cataract development is not uncommon after glaucoma surgery. Device position remained stable overall, and visual function parameters showed no clinically significant changes. CONCLUSIONS: INTERCIL® provided sustained IOP and medication reduction by potentially harnessing uveoscleral outflow, without surgical risks associated with bleb- or cleft- dependent procedures, suggesting a potential new concept for patients with open-angle glaucoma requiring durable disease control. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT05236439.