Bio-Interventional Uveoscleral Outflow Enhancement for Intraocular Pressure Reduction in Open-Angle Glaucoma: One-Year Results of a Multicenter Prospective Real-world Evidence Study

Background: Open-angle glaucoma (OAG) is a chronic optic neuropathy and major cause of blindness. Current treatments lower intraocular pressure (IOP) by enhancing aqueous outflow via the trabecular or uveoscleral pathways. This study reports on the safety and efficacy of a novel bio-interventional procedure for the surgical enhancement of uveoscleral outflow in OAG patients. Methods: This is a prospective analysis of an interventional cohort of a multicenter, real-world safety and effectiveness study of stand-alone uveoscleral outflow enhancement. Patients with OAG and intraocular pressure inadequately controlled on medical therapy underwent ab-interno cyclodialysis intervention with scleral bio-tissue reinforcement and were prospectively followed through 12 months postoperatively. Key efficacy and safety outcomes were the change in mean medicated IOP, the mean change in number of IOP lowering medications from baseline, and the incidence of ocular adverse events. Results: This primary analysis includes 41 cases who underwent successful stand-alone uveoscleral outflow intervention and completed 12-month follow-up. Among them, 37% had failed prior MIGS and SLT procedures. Additionally, 66% had failed IOP control with medical therapy and were surgical candidates for conventional glaucoma filtration or tube surgery. The baseline medicated IOP for all 41 eyes was 21.6 ± 5.0 mmHg, with an average preoperative medication burden of 2.8 ± 1.3. At 12 months, mean medicated IOP decreased by 31% to 14.7 ± 5.4 mmHg (p < 0.01), and the mean number of medications was reduced to 1.9 ± 1.0. Notably, 71% of treated eyes achieved a >20% IOP reduction from baseline on the same of fewer medications. During the 12-month follow-up period, only 3 eyes required additional incisional glaucoma surgery. The procedure was well tolerated, with no reported cases of bio-tissue migration, significant postoperative inflammation, change in visual acuity or clinically-significant hyphema. Conclusion: At the 12-month mark, ab-interno cyclodialysis with allograft reinforcement demonstrated a favorable safety profile and sustained IOP reduction as a standalone treatment. This conjunctiva-sparing, minimally invasive approach to enhancing uveoscleral outflow presents a promising surgical option—especially for patients in whom prior trabecular MIGS have failed, potentially reducing the need for more invasive interventions.