Roche Holding Ltd · SIX:RO

Roche — Technical Presentation (February 2024)

11 slides from Roche's technical presentation, Feb 7, 2024

  1. Slide 1: Greater Volume Reduction of Hyperreflective Foci in DME With Faricimab vs Aflibercept

    Greater Volume Reduction of Hyperreflective Foci in DME With Faricimab vs Aflibercept in Phase 3 YOSEMITE/RHINE Usha Chakravarthy, FRCOphth, PhD, CBE1 Rishi P. Singh, MD2; Andreas Maunz, PhD3; Esther von Schulthess, PhD3; Katie Patel, MSc3; Isabel Bachmeier, MD3; Ian Lloyd Jones, PhD3; Yaniv Cohen,

  2. Slide 2: Disclosures

    Disclosures Financial Disclosures  UC: Consultant: Apellis, Boehringer Ingelheim, Iveric Bio, Roche; Data Safety Monitoring Committee: Adverum, Oxurion  RPS: Research Grant: Aerie, Apellis, Graybug; Consultant: Alcon, Bausch + Lomb, Genentech, Inc., Gyroscope, Novartis, Regeneron  AM, EvS, KP, IL

  3. Slide 3: In DME, HRF May be a Biomarker for Disease Severity and Progression

    In DME, HRF May be a Biomarker for Disease Severity and Progression Hyperreflective foci (HRF): 2 main hypotheses regarding HRF origin in DME: • ≤ 50 µM diameter, highly reflective dots on SD-OCT1 • Activated inflammatory cells4,10 • Present throughout the retina in DME and nAMD2,3 • Lipid and/or pr

  4. Slide 4: Volumetric Analysis of HRF in YOSEMITE/RHINE Using a Deep Learning-Based Algorithm

    Volumetric Analysis of HRF in YOSEMITE/RHINE Using a Deep Learning-Based Algorithm Post-processed result of YOSEMITE/RHINE Pooled: Post Hoc Analysis Original B-scan HRF segmentation Data up to week 48: • Faricimab 6.0 mg Q8W, n = 519 • Faricimab 6.0 mg T&E, n = 524 • Aflibercept 2.0 Q8W, n = 502 En-

  5. Slide 5: Baseline Total Retinal HRF Volume Associated With Markers of Disease Severity

    Baseline HRF Volumes in Total Retinaa Were Associated With Markers of Disease Severity YOSEMITE/RHINE Pooled: Post Hoc Analysis 99.7% of patients had HRF present at baselineb DRSS (N = 1489) CST (N = 1510) BCVA (N = 1524) P < 0.0001c P < 0.0001c P = 0.36334c Across DRSS groups Across CST groups Acro

  6. Slide 6: HRF Colocalize to Regions of Cystoid IRF

    HRF Colocalize to Regions of Cystoid IRF IRF HRF Volumetric Segmentation B-scans A-scans A-scans En-face B-scans Projection A-scans A-scans 6 HRF, hyperreflective foci; IRF, intraretinal fluid.

  7. Slide 7: Case: Reduction of HRF From Baseline to Week 48 With Faricimab

    Case: Reduction of HRF From Baseline to Week 48 With Faricimab Post-processed result of Original B-scan HRF segmentation HRF Baseline BCVA 57 letters CST 553 µm HRF counta 78 HRF Week 16 BCVA 77 letters CST 190 µm HRF counta 25 Week 48 BCVA 78 letters CST 191 µm HRF counta 4 a HRF count is in the to

  8. Slide 8: Greater Reductions in the Inner Retina With Faricimab vs Aflibercept

    Greater Reductions in HRF Volumes in the Inner Retinaa With Faricimab vs Aflibercept YOSEMITE/RHINE Pooled: Post Hoc Analysis Inner Retina 1-mm Diameter Inner Retina 3-mm Diameter 350 1800 * * ** Adjusted Mean HRF Volume, pL Adjusted Mean HRF Volume, pL 300 * ** ** ** 1500 * ** 250 ** ** ** ** ** **

  9. Slide 9: Greater Reductions in the Outer Retina With Faricimab vs Aflibercept

    Greater Reductions in HRF Volumes in the Outer Retinaa With Faricimab vs Aflibercept YOSEMITE/RHINE Pooled: Post Hoc Analysis Outer Retina 1-mm Diameter Outer Retina 3-mm Diameter 200 2000 Adjusted Mean HRF Volume, pL Adjusted Mean HRF Volume, pL * 150 1600 * * ** ** * * ** 100 1200 * ** * ** ** **

  10. Slide 10: Faricimab Reduced the Inner and Outer Retina, Whereas Aflibercept's Effects Were Localized to the Outer Retina

    Faricimab Reduced HRF Volumes in the Innera and Outerb Retina, Whereas Aflibercept’s Effects Were Localized to the Outer Retina YOSEMITE/RHINE Pooled: Post Hoc Analysis HRF Volume as a Proportion of 0.6 Baseline at Week 48c 0.4 0.2 0.0 Inner Retina, 1 mm Outer Retina, 1 mmc Inner Retina, 3 mm Outer

  11. Slide 11: Faricimab Results in Greater Resolution of HRF vs Aflibercept in DME

    Faricimab Results in Greater Resolution of HRF vs Aflibercept in DME Volumetric assessment of HRF in YOSEMITE/RHINE demonstrated: ► Association of HRF volumes ► Colocalization of HRF and ► Greater retinal HRF volume with DRSS and CST at cystoid IRF at baseline suggests and count reductions in baseli

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