Slide 1: Three-Year Outcomes of Aflibercept 8mg in Diabetic Macular Edema: PHOTON Extension
Extension hree-Year Outcomes of Aflibercept 8mg in Diabetic Macular Edema: Safety and Efficacy Results From the PHOTON Extension Study W. Lloyd Clark, MD,’ on behalf of the PHOTON extension study investigators 1Palmetto Retina, West Columbia, SC, USA Presented at Angiogenesis, Exudation, and Degener
Slide 2: Disclosures
Disclosures EE Extension « W. Lloyd Clark has received consultant fees from Genentech and Regeneron Pharmaceuticals, Inc; research funds from Genentech; lecturer fees from Bayer, Genentech, and Regeneron Pharmaceuticals, Inc; and travel support from Bayer, Genentech, and Regeneron Pharmaceuticals, I
Slide 3: PHOTON Extension Study Design
PHOTON Extension Study Design PHOTON PHOTON Extension Extension 2q8 2q8>8mg cept 2 mg every 8 weeks Patients switched to =r 5 initial monthly injections aflibercept 8 mg every 12 weeks n=167 n=70 Treatment-naive and previously treated Aflibercept 8 mg every patients with after 3 initial monthly inje
Slide 4: PHOTON Extension Study Design
PHOTON Extension Study Design photon Extension 2q8>8mg + All patients received aflibercept 8 mg through Week 156 0 - Patients who were treated with aflibercept 2q8 were switched to aflibercept 8 mg at Week 96 and immediately assigned to a 12-week dosing interval « Mandatory visits were every 4 weeks
Slide 5: Patient Disposition and Baseline Characteristics
Patient Disposition and Baseline Characteristics Patients entering PHOTON study (FAS) PHOTON Extension 2q8>8mg 8mg? Patients entering PHOTON extension (eFAS) 195 Completion rate at Week 96 (%) 100 Completion rate at Week 156 (%) 77.9% Age (years) 62.3 (10.4) 62.7 (8.5) |) 61.5(11.3) || 61.8 (10.7) F
Slide 6: BCVA: All Patients in PHOTON Extension
Mean BCVA Through Week 156 All Patients in PHOTON Extension EE Extension PHOTON PHOTON Extension Total (N=265) Absolute LS mean change BCVA from BL? 62.5 71.2 87 70.3 78 70.9 69 n (4 a = 2 no [14 a Ee Ww t > oO a <c is] o = 120 132 144 eFAS, observed cases LS mean values were generated using MMRM an
Slide 7: BCVA
Mean BCVA? Through Week 156 2q8 > 8&mg and 8mg? Patients PHOTON PHOTON Extension (2q8 vs 8mg>) (2q8>8mg vs 8mg>) 71.3 70.9 EE Extension | | 70.7} I 8mg? (n=195) n (4 a = 2 an [14 a Ee Ww t > oO a <c is] o = 24 36 48 60 108 120 132 144 Mean number of injections Mean number of injections from baseline
Slide 8: CRT
Mean CRT Through Week 156 8mg? Patients Extension PHOTON PHOTON Extension £ = E a o c oO o = 72 84 Week LS mean change from baseline (um) Week 48 Week 96 Week 156 8mg? (n=195) -180.6 178.4 -192.4 Patients who were randomized to the 8q12.or 8q16 groups at the beginning of the PHOTON study and continu
Slide 9: Mean CRT
£ =a E a rs) < c o = Mean CRT Through Week 156 2q8> 8mg Patients PHOTON PHOTON Extension Extension (2q8>8mg) (2q8) Synchronized dosing of aflibercept 2 mg every 8 weeks through Week 88 84 108 120 ky 144 Week LS mean change from baseline (um) Week 48 Week 96 -161.7 -169.7 72 2q8>8mg (n=70) eFAS, obse
Slide 10: CRT
Mean CRT Through Week 156 2q8> 8mg Patients Extension PHOTON PHOTON Extension : (2q8) (2q8>8mg) Following a single injection of aflibercept 8 mg, a 54-m reduction in CRT was observed - a fo} Synchronized dosing of aflibercept 2 mg every 8 weeks through Week 88 aN ro ro} £ =a E a rs) < c o = LS mean
Slide 11: CRT
Mean CRT Through Week 156 2q8 > 8mg Patients ~~ PHOTON PHOTON Extension Extension (248) (2q8>8mg) Following a single injection of aflibercept 8 mg, Synchronized dosing of aflibercept 2 mg a 54-um reduction in CRT was observed every 8 weeks through Week 88 Compared with the first 2 years of treatment
Slide 12: Majority of Aflibercept 8 mg-Treated Patients Achieved Extended Dosing Intervals at Week 156
Majority of Aflibercept 8 mg-treated Patients photon . . ~ Achieved Extended Dosing Intervals at Week 156 Extension Last Completed Dosing Interval Last Assigned Dosing Interval SS x - wm Q24 s* 100 5 eo. 100 n 2) mQ20-Q22 9 < aos |B 80 25% 45% GS 380] 28% 48% a2za4 8 9, 2020 3 2020 Hm Q8-Q10 5 80 20
Slide 13: Ocular and Non-ocular Safety
Ocular and Non-ocular Safety Through Week 1562 2q8>8mg N (eSAF) 70 195 Ocular AEs, n (%)° 37 (52.9) 108 (55.4) Ocular SAEs, n (%)¢ 3 (4.3) 4 (2.1) Intraocular inflammation, n (%)° 1 (1.4) 3 (1.5) Iritis 0 2 (1.0) Iridocyclitis 1 (1.4) 0 Uveitis 1 (1.4) 0 Endophthalmitis ie} 1 (0.5) Non-ocular SAEs,
Slide 14: PHOTON Extension: Key Week 156 Results
PHOTON Extension: Key Week 156 Results ==> Patients in the 8mg group maintained visual and anatomic improvements achieved in the first 2 years, with the majority of patients orExtension extended dosing intervals -— 45% completed 220-week dosing intervals and 48% had a last assigned dosing interval o