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Diabetic Macular Edema

DME is a vision-threatening eye condition that affects people with type 1 and type 2 diabetes, characterized by the accumulation of fluid from leaky vessels resulting in swelling of the macula, and is a leading cause of vision loss globally. Roche is committed to the development of new treatments and treatment strategies that optimize vision outcomes to improve the lives of patients and their caregivers.

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Apr 7 / Roche and Genentech
Impact of Early Intraretinal Fluid Reduction on One-Year Outcomes in Diabetic Macular Edema
Intraretinal fluid is a key biomarker of disease activity and responses to treatment in diabetic macular edema. However, the relationship between anatomical and visual outcomes is poorly understood. This analysis demonstrated that greater IRF volume reduction within 1 month correlates with improved anatomical and visual outcomes at 1 year, highlighting the importance of rapid fluid reduction for better long-term results.

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Apr 7 / Roche and Genentech
Treatment Response and Safety of Faricimab▼ in Underrepresented Patients With Diabetic Macular Edema (DME): Year 1 Top-Line Results From the Phase 4 ELEVATUM Study
The presentation described ELEVATUM study, a multinational, open-label, phase 4 clinical trial conducted across the United States (US), Kenya, and India. In the US, approximately 120 patients were enrolled across 40 sites. Enrollment is complete in Kenya, and India. The primary endpoint is the change in best-corrected visual acuity (BCVA) at week 56. The study achieved rapid recruitment and demonstrated a high treatment completion rate of 87% despite the perceived challenges of recruitment and follow-ups in underrepresented populations.

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Apr 7 / Roche and Genentech
Greater Reduction in Hard Exudates with Faricimab▼ Versus Aflibercept in Patients with Diabetic Macular Edema: Biomarker Results from the Phase 3 YOSEMITE/RHINE Trials
In this presentation, key biomarker results from the phase 3 YOSEMITE/RHINE trials of faricimab▼ in patients with DME are summarized. Assessment of hard exudates (HEs) in YOSEMITE/RHINE demonstrated that faricimab▼ results in greater reduction of retinal HEs vs aflibercept in DME. The findings reflected improved vascular stability and disease control with dual Ang-2/VEGF-A inhibition, supporting the potential of faricimab▼ to improve outcomes beyond VEGF alone in patients with DME.

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Apr 7 / Roche and Genentech
Port Delivery System With Ranibizumab (PDS) for Continuous Treatment of Diabetic Macular Edema (DME): 2-Year Data From the Phase 3 Pagoda Trial
This presentation described results from a post hoc analysis investigating retinal fluid and thickness fluctuations and the impact of these features on vision outcomes in patients with DME in the phase 3 Pagoda trial. In patients with DME, continuous delivery with PDS controlled retinal fluctuations and maintained vision over 48 weeks, comparable to IVT.

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Apr 7 / Roche and Genentech
Faricimab▼ in Diabetic Macular Edema: Results from the RHONE-X Long-Term Extension Trial
This presentation reports key findings from the RHONE-X extension trial that demonstrated the long-term safety and efficacy of faricimab▼ treat & extend in patients with DME who rolled over from the YOSEMITE and RHINE clinical trials. BCVA gains and CST improvements from parent trials were maintained in RHONE-X, with approximately 80% of patients on ≥ Q12W faricimab▼ dosing intervalsand >90% patients achieved absence of DME by the end of the trial.

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Apr 5 / Roche and Genentech
Assessment of the Clinical Effects of Anti-Ang-2 With Faricimab▼ Based on Key Outcomes From the YOSEMITE/RHINE Trials and Real-World FARETINA/FARWIDE Studies in Patients With Diabetic Macular Edema (DME)
In this presentation, key clinical and anatomic outcomes from the phase 3 YOSEMITE/RHINE trials and real-world FARETINA/FARWIDE studies in patients with DME are summarized. Clinical biomarkers in DME for vascular leakage, inflammation and fibrosis demonstrated greater disease control and vascular stability with faricimab▼ vs aflibercept and were discussed in detail in this presentation.

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