Slide 1: Intravitreal Aflibercept 8 mg for DME: Week 48 Efficacy Outcomes by Baseline Demographics
Intravitreal Aflibercept 8 mg for Diabetic Macular Edema: Week 48 Efficacy Outcomes by Baseline Demographics in the Phase 2/3 PHOTON Trial Dennis M. Marcus,1 on behalf of the PHOTON study investigators 1Southeast Retina Center, Augusta, GA, USA Presented at the 56th Annual Scientific Meeting of the
Slide 2: Disclosures
Disclosures DME • Dr Marcus has served as a consultant for Regenxbio, Genentech/Roche, Regeneron, Clearside, Vial, Coherus, and Vantage Biosciences and has received research grants from Amgen, Ionis, Xplore, Mylan, Opthea, Clearside, Iveric, Outlook, Gemini, Genentech, Graybug, Topcon, Gyroscope, St
Slide 3: Background
Background DME ¢ Aflibercept 8 mg, a novel intravitreal formulation that delivers a 4-times higher molar dose than aflibercept 2 mg, has demonstrated improved functional and anatomic outcomes at dosing intervals of 212 weeks in ongoing clinical trials These findings supported regulatory approval of
Slide 4: PHOTON Study Design
PHOTON Study Design Multi-center, randomized, double-masked study in patients with DME? Randomized 1 (2q8) : 2 (8q12) : 1 (8q16) Note: 2 mg arm received 5 initial monthly injections versus 8 mg arms, which received only 3 initial monthly injections 2q8 Aflibercept 2 mg every 8 weeks after 5 initial
Slide 5: PHOTON: Dose Regimen Modifications in Year 1
* PHOTON: Dose Regimen Modifications in Year 1 protgp DME Prima Endpoint Note: 2 mg arm received 5 initial monthly injections versus 8 mg arms, which received only 3 initial monthly injections DRM Criteria fo ortening Dosing Interval? DRM in Year 1 * >10-letter loss in BCVA due to persistent or wors
Slide 6: Baseline Demographics
Baseline Demographics N (FAS/SAF) 167 328 163 658 Age (years) 63.0 (9.8) 62.1 (11.1) 61.9 (9.5) 62.3 (10.4) Female (%) 44.9% 36.0% 39.3% 39.1% Race (%) White 67.1% 70.4% 78.5% 71.6% Black or African American 10.8% 10.7% 5.5% 9.4% Asian 18.0% 14.6% 14.1% 15.3% Other 2.4% 3.0% 0.6% 2.4% Not reported 1
Slide 7: Baseline Characteristics of the Study Eye
Baseline Characteristics of the Study Eye N (FAS/SAF) 167 328 163 658 BCVA (ETDRS letters) 61.5 (11.2) |} 63.6(10.1) |) 61.4 (11.8) |] 62.5 (10.9) Snellen equivalent 20/63 20/50 20/63 20/63 20/32 (>73 to 78 letters) 12.0% 18.0% 14.1% 15.5% 20/40 or worse (S73 letters) 88.0% 82.0% 85.9% 84.5% CRT (um
Slide 8: Mean Change in BCVA Through Week 48
Mean Change in BCVA Through Week 48a
Slide 9: Mean Change in BCVA at Week 48 by Age
Mean Change in BCVA at Week 48 by Age? <55 years 255-<65 years 265-<75 years 13.0 02 11.1 Mean Change (SD) in BCVA, ETDRS Letters Mean Change (SD) in BCVA, ETDRS Letters BL BCVA 62.5 65.0 63.2 BL BCVA 10) 2q8 = 8q12.—s Bq 16 2q8 8qi2 8q16 (n=28) (n=69) (n=37) (n=53) (n=91) (n=52) Mean Change (SD) in
Slide 10: Mean Change in BCVA at Week 48 by Sex
Mean Change in BCVA at Week 48 by Sex
Slide 11: Mean Change in BCVA at Week 48 by Race
Mean Change in BCVA at Week 48 by Racea
Slide 12: Mean Change in BCVA at Week 48 by Ethnicity
Mean Change in BCVA at Week 48 by Ethnicity
Slide 13: Mean Change in BCVA at Week 48 by Baseline BCVA
Mean Change in BCVA at Week 48 by Baseline BCVA
Slide 14: Mean Change in BCVA at Week 48 by Baseline CRT
Mean Change in BCVA at Week 48 by Baseline CRT
Slide 15: Proportion of 8 mg Patients Maintaining Dosing Interval by Race
Proportion of 8 mg Patients Who Maintained Randomized Dosing Interval Through Week 48 by Race
Slide 16: Proportion of 8 mg Patients Maintaining Dosing Interval by Ethnicity
Proportion of 8 mg Patients Who Maintained Randomized Dosing Interval Through Week 48 by Ethnicity
Slide 17: Limitations
Limitations DME • This analysis was not designed to evaluate statistical differences within subgroups • Select subgroups (age ≥75 years and Black or African American race) could not be evaluated due to small sample size 18
Slide 18: Conclusions
Conclusions DME Mean Change in BCVA at Week 48 by Age? Mean Change in BCVA at Week 48 by Ethnicity 265-<75 years Hispanic or Latino Not Hispanic or Latino a3 8 BCVA, ETORS Letters ‘Mean Change (SD) 2 Mean Change (sD) ‘Mean Change (SD) InBCVA, ETORS Letters Mean Change (SD) BCVA, ETORS Letter 3 inBCV