Slide 1: Week 48 Outcomes in Aflibercept 8 mg- and 2 mg-treated Patients by Prior DME Treatment Status
Week 48 Outcomes in Aflibercept 8 mg- and 2 mg-treated Patients by Prior DME Treatment Status: A Subgroup Analysis of the Phase 2/3 PHOTON Trial Andrew A. Moshfeghi, MD," on behalf of the PHOTON study investigators ‘Department of Ophthalmology, Keck School of Medicine, USC Roski Eye Institute, Unive
Slide 2: Disclosures
Disclosures « Dr. Moshfeghi has served as a consultant for Allergan, Alimera, Annexon, Apellis, Genentech/Roche, Novartis, Ocular Therapeutix, OcuTerra, Pr3vent, Regeneron Pharmaceuticals, Inc., SciNeuro, Valitor, and Waldo dba Ainsly Ltd.; has received research funding from Genentech/Roche, Novarti
Slide 3: Background
Background DME + Aflibercept 8 mg is a novel intravitreal formulation that delivers a 4-times higher molar dose than aflibercept 2 mg, potentially extending VEGF suppression over a longer period of time In the PHOTON trial, aflibercept 8 mg demonstrated non-inferior BCVA gains with extended dosing i
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
a photom PHOTON: Dose Regimen Modifications in Year 1 ~ DNME Prima Endpoint Note: 2 mg arm received 5 initial monthly injections versus 8 mg arms, which received only 3 initial monthly injections DRM Criteria for Shortening Dosing Interval@ DRM in Year 1 * >10-letter loss in BCVA due to persistent o
Slide 6: Baseline Demographics
Baseline Demographics DME With Prior DME Treatment Without Prior DME Treatment 64.4 (8.9) |) 62.8(11.0) | 63.0 (8.4) 62.0 (10.4) |) 61.6 (11.3)) 60.9 (10.3) Age, years 40.8 44.1 33.5 38.0 Female, % 45.9 39.2 Race, % White 64.9 69.9 77.5 68.8 70.8 79.3 Asian 21.6 19.6 18.3 15.1 10.8 10.9 9.5 7.0 42 1
Slide 7: Baseline Ocular Characteristics
Baseline Ocular Characteristics BCVA, ETDRS letters With Prior DME Treatment 62.1 (10.9) 62.3 (10.5) 58.6 (11.9) DME Without Prior DME Treatment 2q8 (n=93) Snellen equivalent, % 20/32 (>73 to 78 letters) 14.9 16.8 5.6 20/40 or worse ($73 letters) 85.1 83.2 94.4 61.0 (11.5) I} 64.7 (9.7) |) 63.7 (11.
Slide 8: Mean Change in BCVA Through Week 48
Mean Change in BCVA Through Week 48 With Prior DME Treatment 15 #298 (n=74) -@+8q12 (n=143) —&-8q16 (n=71) ° ETDRS letters ao ° <= > (3) a & o Db f= S ce ° = os o = Without Prior DME Treatment 15 #298 (n=93) + 8q12 (n=185) —2~8q16 (n=92) o ETDRS letters a ° Mean change in BCVA, FAS, observed cases.
Slide 9: Proportion of Patients With ≥2-step DRSS Improvement From Baseline at Week 48
Proportion of Patients With 22-step DRSS Improvement From Baseline at Week 48 With Prior DME Treatment Without Prior DME Treatment = ° ro) = fo) fo} aN a fox) o a 3 5 a for) f=) o f=) N lo} N o Proportion of patients, % Proportion of patients, % LJ r L 298 8q12 2q8 8q12 8q16 (n=71) (n=135) (n=87) (n
Slide 10: Proportion of Patients With Baseline DRSS and ≥ Step DRSS Improvement
Proportion of Patients With Baseline DRSS 47 or Worse and 22-step DRSS Improvement From Baseline at Week 48 With Prior DME Treatment Without Prior DME Treatment o fo} 84% ; : 2q8 8q12 8q16 2q8 8q12 8q16 (n=19) (n=40) (n=17) (n=34) (n=73) (n=29) & a o f=) o f=) 1 nN oO Proportion of patients, % Propo
Slide 11: Mean Change in CRT Through Week 48
Mean Change in CRT Through Week 48 With Prior DME Treatment Mean change in CRT, pm #298 (n=74) —-™-8q12 (n=143) —*-8q16 (n=71) Mean change in CRT, pm —#2q8 (n=93) -@-8q12 (n=185) —s—8q16 (n=92) FAS, observed cases.
Slide 12: Proportion of Patients Who Maintained Their Randomized Intervals Through Week 48
Proportion of Patients Who Maintained Their Randomized Intervals Through Week 48 With Prior DME Treatment Without Prior DME Treatment Qs All 8 mg (n=255)° Values may not add up to 100% due to rounding, Patients whose dosing intervals were shortened based on DRM assessments at some point through Week
Slide 13: Conclusions
Conclusions Mean Change in BCVA Through Week 48 Proportion of Patients With 22-step DRSS Improvement From Baseline at Week 48 With Pri OME Treatment Without Prior OME Treatment age omy sts) as) inn a Proportion of Patients Who Maintained Their Randomized Intervals Through Week 48 Wh Por OME Treatmen