Slide 1: Exposure to Residual IRF and CST Fluctuations on Outcomes in CRVO Macular Edema
xposure to Residual Intra ctuations of Central Subfield Thickness on Outcomes in Eyes with Macular Edema following Centra Retinal Vein Occlusion: A 1-Year Post Hoc Analysis of the COPERNICUS and GALILEO Trials Michael Ip MD on behalf of the COPERNICUS and GALILEO study investigators Doheny Eye Cente
Slide 2: Disclosures
Disclosures CONSULTANT: Alimera, Allergan, Amgen, Apellis, Clearside, Genentech, Novartis, OCCURX, Regeneron RESEARCH SUPPORT: Astellas, Biogen, Genentech, Lineage Cell Therapeutics, Regeneron, Regenxbio, Splice Bio, 4DMT This analysis was funded by Regeneron Pharmaceuticals, Inc. (Tarrytown, New Yo
Slide 3: Background and Objectives
Background and Objectives « SCORE2: Greater CST fluctuations were associated with worse visual outcomes in eyes with macular edema following CRVO receiving anti-VEGF treatment' « LEAVO: Persistent or recurrent IRF was associated with worse visual outcomes in eyes with macular edema following CRVO re
Slide 4: Background and Objectives
Background and Objectives * SCORE2: Greater CST fluctuations were associated with worse visual outcomes in eyes with macular edema following CRVO receiving anti-VEGF treatment! « LEAVO: Persistent or recurrent IRF was associated with worse visual outcomes in eyes with macular edema following CRVO re
Slide 5: Methods
Methods - Analyses were conducted in eyes treated with IAI using the integrated COPERNICUS and GALILEO dataset through Week 24, and the GALILEO dataset alone through Week 52
Slide 6: Methods
Methods - Analyses were conducted in eyes treated with IAI using the integrated COPERNICUS and GALILEO dataset through Week 24, and the GALILEO dataset alone through Week 52 + Impact of exposure to residual IRF was assessed based on the number of visits with IRF from baseline to Week 24 or 52: COPER
Slide 7: Methods
Methods - Analyses were conducted in eyes treated with IAI using the integrated COPERNICUS and GALILEO dataset through Week 24, and the GALILEO dataset alone through Week 52 + Impact of exposure to residual IRF was assessed based on the number of visits with IRF from baseline to Week 24 or 52: COPER
Slide 8: Methods
Methods - Analyses were conducted in eyes treated with IAI using the integrated COPERNICUS and GALILEO dataset through Week 24, and the GALILEO dataset alone through Week 52 + Impact of exposure to residual IRF was assessed based on the number of visits with IRF from baseline to Week 24 or 52: COPER
Slide 9: Outcomes by Exposure to Residual IRF Through Week 24: Integrated Analysis
Outcomes by Exposure to Residual IRF Through Week 24: COPERNICUS and GALILEO Integrated Analysis —_
Slide 10: Outcomes Through Week 24 by Subgroups of IRF Exposure
Outcomes Through Week 24 by Subgroups of IRF Exposure -t G1: 0-1 visits with IRF (n=84) = G2: 2-3 visits with IRF (n=67) -@®- G3: 4-7 visits with IRF (n=53) Mean Change in BCVA From Baseline Mean Change in CST From Baseline 25 5 ov > 20 — os oz red ze io S15 io O BB BO Ge to gs i<j 23 £2 no? 5 as 46
Slide 11: Difference in VFQ-25 Scores at Week 24 by IRF Exposure
General health General vision Near activities Difference in VFQ-25 Composite and Subscale Scores at Week 24 by Subgroups of IRF Exposure LS-Mean Diff (95% Cl) VFQ composite LS-Mean Diff (95% Cl) 0.9 (-2.2, 3.9) 3.1 (6.6, 0.4) LS-Mean Diff (95% Cl) 1.2 (6.7, 4.3) 0.3 (-3.8, 4.5) 1.5 (6.2, 3.2) 1.0 (5
Slide 12: Outcomes by Exposure to Residual IRF Through Week 52: GALILEO Analysis
Outcomes by Exposure to Residual IRF Through Week 52: GALILEO Analysis
Slide 13: Outcomes Through Week 52 by Subgroups of IRF Exposure
Outcomes Through Week 52 by Subgroups of IRF Exposure -—# G1: 0-3 visits with IRF (n=32) -l G2: 4-7 visits with IRF (n=36) -@®- G3: 8-14 visits with IRF (n=20) Mean Change in BCVA From Baseline Mean Change in CST From Baseline Week 0 4 8 12 16 20 24 28 32 36 40 44 48 52 30 - Ome 2 G 25 = =e 3% OF 2.
Slide 14: GALILEO: Difference in VFQ-25 Scores at Week 52 by IRF Exposure
GALILEO Difference in VFQ-25 Composite and Subscale Scores at Week 52 by Subgroups of IRF Exposure LS-Mean Diff (95% Cl) 1 VFQ —e -2.8 (-6.3, 0.7) = -1.3 (-5.7, 3.1) composite LS-Mean Diff (95% Cl) 4 LS-Mean Diff (95% Cl) T General —e— health 7.5 (-14.6, -0.3) Distance -0.4 (6.6, 5.8) activities i _
Slide 15: Outcomes by Quartiles of CST Fluctuation Through Week 24: Integrated Analysis
Outcomes by Quartiles of CST Fluctuation From Week 4 to Week 24: COPERNICUS and GALILEO Integrated Analysis ee
Slide 16: Mean Change in BCVA From Baseline by Quartiles of CST Fluctuation
Mean Change in BCVA From Baseline Through Week 24 by Quartiles of CST Fluctuation whe Q1: 512.7 pm (n=53) HF Q2: 312.7 to <19.1 um (n=51) -@® Q3: >19.1 to $30.7 ym (n=52) -@ Q4: >30.7 ym (n=51) 25 N 3 a LS mean (95% Cl) change in BCVA, letters ) Week LS mean and inference were calculated from an MMR
Slide 17: Difference in VFQ-25 Scores by Quartiles of CST Fluctuation
Difference in VFQ-25 Composite and Subscale Scores at Week 24 by Quartiles of CST Fluctuation LS-Mean Diff (95% Cl) —e14 -1.3 (-5.0, 2.4) VFQ 1 composite —e -2.2 (-5.9, 1.5) ee") -2.3 (6.2, 1.6) t LS-Mean Diff (95% Cl) ! LS-Mean Diff (95% Cl) 1 @— 3.0(-3.5, 9.5) 2.2 (8.3, 4.0) 1.0 (6.2, 4.3) oe ’ 0.
Slide 18: Outcomes by Tertiles of CST Fluctuation Through Week 52: GALILEO Analysis
Outcomes by Tertiles of CST Fluctuation From Week 4 to Week 52: GALILEO Analysis ee
Slide 19: GALILEO: Mean Change in BCVA by Tertiles of CST Fluctuation
GALILEO Mean Change in BCVA From Baseline Through Week 52 by Tertiles of CST Fluctuation whe 11: $24.6 pm (n=32) 9 12: >24.6 to <99.5 tim (n=33) -@ T3: >99.5 pm (n=32) N N w a a a 1 LS mean (95% Cl) change in BCVA, letters os a LS mean and inference were calculated from an MMRM model. The model incl
Slide 20: GALILEO: Difference in VFQ-25 Scores by Tertiles of CST Fluctuation
GALILEO Difference in VFQ-25 Composite and Subscale Scores at Week 52 by Tertiles of CST Fluctuation LS-Mean Diff (95% Cl) VFQ composite -3.1 (-6.7, 0.5) -1.7 (5.3, 1.9) LS-Mean Diff (95% Cl) LS-Mean Diff (95% Cl) General 0.9 (-6.8, 8.7) Distance health activities 1.2 (9.0, 6.7 General ~3.8 (-95, 2.
Slide 21: Conclusions
Conclusions * Greater exposure to residual IRF was associated with a trend towards lower BCVA gains through Week 24 and Week 52 ¢ Higher CST fluctuation was associated with a trend towards lower BCVA gains through Week 24 and Week 52 ¢ Similar vision-related quality of life responses (composite and