Roche Holding Ltd · SIX:RO

Roche — American Society of Retina Specialists 2024 Meeting

13 slides from Roche's conference presentation, Jul 17, 2024

  1. Slide 1: 12-Month Real-World Clinical and Anatomical Outcomes With Faricimab in Patients With DME: FARETINA-DME

    12-Month Real-World Clinical and Anatomical Outcomes With Faricimab in Patients With Diabetic Macular Edema: The FARETINA-DME Study Theodore Leng, MD1 Durga Borkar, MD, MMCi2; David Tabano, PhD3; Stella Ko, MS, PharmD3; Jacqueline Shaia, MS4; Rachel Myers, MPH5; Ferhina Ali, MD, MPH6; and Rishi P. S

  2. Slide 2: Disclosures

    Disclosures Financial Disclosures ► TL: Grants: Astellas; Consultant: Alcon, Apellis, Astellas, Genentech, Inc./Roche, Graybug, Nanoscope, Protagonist, Regeneron, Verana Health ► DB: Consultant: Allergan/AbbVie, Apellis, Genentech, Inc., Glaukos, Iveric Bio, ONL Therapeutics, Verana Health; Speaker:

  3. Slide 3: Several Real-World Studies of Faricimab in DME Are Ongoing

    Several Real-World Studies of Faricimab in DME Are Ongoing ► Faricimab (Vabysmo ®) is approved in > 95 countries, including in the US (Jan 2022) and EU (Sep 2022) 1,2 ► Faricimab is the first bispecific antibody for intraocular use that independently binds and neutralizes both Ang-2 and VEGF-A with

  4. Slide 4: FARETINA-DME Is a Retrospective, Real-World Study of Faricimab Using IRIS Registry Data

    FARETINA-DME Is a Retrospective, Real-World Study of Faricimab Using Data From the IRIS® Registry The American Academy of Ophthalmology IRIS® Registry (Intelligent Research in Sight) contains data from: 540 million > 75 million 16,000 60 electronic medical record de-identified de-identified clinicia

  5. Slide 5: Faricimab DME Cohort

    Faricimab DME Cohort Record of first faricimab injection Feb 7, 2022–Mar 31, 2023 Patients, n = 56,683 (100%) Eyes, n = 71,498 (100%) Eyes without documentation of nAMD on index date Patients, n = 11,992 (21.2%) Eyes, n = 17,020 (23.8%) Eyes with DME diagnosis, laterality, and known patient demograp

  6. Slide 6: Baseline Demographics of 12-Month DME Cohort

    Baseline Demographics of 12-Month DME Cohort Treatment Naïve Previously Treated Baseline Characteristics (Patient-Level) n = 786 n = 4862 Age at first faricimab injection, mean (SD) 67.6 (10.1) 67.2 (10.3) Sex, n (%) Female 376 (47.8) 2239 (46.1) Race, n (%) White or Caucasian 517 (65.8) 3184 (65.5)

  7. Slide 7: Approximately 61% of Previously Treated Eyes Were Switched From Aflibercept 2 mg

    Approximately 61% of Previously Treated Eyes Were Switched From Aflibercept 2 mg ► Mean (SD) prior anti-VEGF injection frequency was 5.6 (2.8) injections in prior 12 months ► Last prior treatment intervala was on average 52.7 (38.9) days, or approximately 7 weeks apart 12-Month Cohort: Percentage of

  8. Slide 8: Vision Improved in Treatment-Naïve Eyes and Was Stable in Previously Treated Eyes

    Vision Improved in Treatment-Naïve Eyes and Was Stable in Previously Treated Eyes 12-Month Cohort: Change in VA From Baselinea Treatment-Naïve Eyes Previously Treated Eyes VA at Baseline VA at Baseline Mean (SD) = 62.5 (19.9) Mean (SD) = 65.8 (17.2) 5 5 Mean Change in VA, Letters (SD) Mean Change in

  9. Slide 9: Mean CST Improved by –43 µm in Treatment-Naïve Eyes and –36 µm in Previously Treated Eyes

    Mean CST Improved by –43 µm in Treatment-Naïve Eyes and –36 µm in Previously Treated Eyes After 5 Injections Mean CST Over Time (among Patients Eyes with CST available)a Treatment-Naïve Eyes Previously Treated Eyes 361.1 * * * 400 343.6 * * * 400 (128.9) 343.2 336.8 * * 328.8 322.8 330.9 324.8 326.3

  10. Slide 10: Fewer Injections Observed in the Latter Months of Faricimab Treatment

    Fewer Injections Observed in the Latter 6 Months of Faricimab Treatment, Indicating Rapid Extension Mean Number of Injections After 12 Months of Faricimab Treatment Treatment-Naïve Eyes Previously Treated Eyes YOSEMITE/RHINE (n = 970) (n = 6725) Faricimab T&E groupa,1 7 7 7 5.8 6 6 6 (1.2) 5.8 Mean

  11. Slide 11: Real-World Use of Faricimab and Observed Rates of IOI and Endophthalmitis

    Real-World Use of Faricimab and Observed Rates of IOI and Endophthalmitis Number of Injections Across Treatment-Naïve Injections Previously Treated Injections FARETINA-AMD/DME Cohorts (n = 19,274) (n = 242,229) Endophthalmitis, n (%)a, b 14 (0.07%) 160 (0.07%) Intraocular Inflammation (IOIs), n (%)a

  12. Slide 12: Take-Home Points

    Take-Home Points FARETINA-DME Uses RWD From the IRIS® Registry for Large Sample, Generalizable Results > 70,000 eyes receiving faricimab > 17,000 with DME 7723 in FARETINA-DME Limitations Real-World Effectiveness Outcomes Safety Outcomes ► Limited to EHR data captured in ► Vision and anatomic improv

  13. Slide 13: Implications of Real-World Data Findings for Faricimab: Patients, Caregivers, and Health Care Systems

    Implications of Real-World Data Findings for Faricimab: Patients, Caregivers, and Health Care Systems Fluid control is considered important for maintenance of long-term outcomes1 ► Rapid, sustained fluid reduction by faricimab can support longer-term outcomes for patients with DME Results after one

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