Abstract
Diabetic macula edema (DME) is a leading cause of vision loss among people with diabetes and requires long-term management strategies that balance efficacy, safety, and durability. Although antivascular endothelial growth factor (VEGF) therapies have improved outcomes, challenges remain in achieving sustained disease control and reducing intravitreal injection frequency. Faricimab is a dual angiopoietin-2/anti-VEGF-A inhibitor designed for intraocular use, which targets the vascular and inflammatory components of DME. The phase 3 YOSEMITE and RHINE clinical trials demonstrated the efficacy, durability, and safety of faricimab throughout 2 years in treatment-naive and previously treated patients with DME. RHONE-X (NCT04432831) was a phase 3, multicenter, nonrandomized, open-label extension trial of the YOSEMITE/RHINE clinical trials that assessed the long-term safety and efficacy of faricimab treat-and-extend (T&E) for an additional 2 years. In this podcast, two retina specialists, Dr. Veeral Sheth (USA) and Dr. Stela Vujosevic (Italy), discuss the outcomes of faricimab after 4 years in DME and the implications on clinical practice. The speakers note that faricimab was well tolerated throughout 2 years of RHONE-X with a safety profile consistent with that observed during 2 years in YOSEMITE/RHINE. Furthermore, vision and anatomical improvements achieved during YOSEMITE/RHINE were maintained through the RHONE-X study, while treatment burden was eased with approximately 80% of patients on a faricimab dosing interval of ≥ every 12 weeks by the end of RHONE-X. Additionally, the proportion of aflibercept-treated patients achieving retinal drying increased after switching to faricimab. The speakers discussed the potential real-world clinical implications of these findings, including improved quality of life for patients and the ability for clinicians to treat more patients due to the reduced treatment burden, while maintaining safety and efficacy. In conclusion, findings from RHONE-X demonstrated the long-term safety, efficacy, and durability of faricimab T&E in DME, all relevant for real-world practice.Trial Registration: ClinicalTrials.gov identifier: NCT04432831. Supplementary material 1 (MP4 1,48,502 kb).