Slide 1: Aflibercept 8 mg in Patients with nAMD: Phase 3 PULSAR Trial 96-Week Results
Aflibercept 8 mg in Patients with Neovascular Age-Related Macular Degeneration: Phase 3 PULSAR Trial 96-Week Results Michael Singer,’ Anat Loewenstein,? Paolo Lanzetta,> Jean-Frangois Korobelnik,*> on behalf of the PULSAR study investigators ‘Medical Center of Ophthalmology, University of Texas Heal
Slide 2: Disclosures
Disclosures MS: Consultant fees from Adverum, Aerie, Alimera, Allergan, Biogen Bausch, Eyepoint, Genentech, Novar#@, Ocular nAMD Therapeutics, and Regeneron Pharmaceuticals, Inc.; served on speakers bureau for Allergan, Apellis, Biogen, Eyepoint, Genentech, and Regeneron Pharmaceuticals, Inc.; contr
Slide 3: PULSAR: A 3-Arm Randomized, Double-Masked, Phase 3 Study
PULSAR: A 3-Arm Randomized, Double-Masked, Phase 3 Study Multicenter, randomized, double-masked study in patients with treatment-naive nAMD Randomized at baseline 1 (2q8) : 1 (8q12) : 1 (8q16) 2q8 Aflibercept 2 mg every 8 weeks after 3 initial monthly injections n=336 Primary endpoint at Week 48 Mea
Slide 4: PULSAR: Dosing Schedule and Regimen Modification
PULSAR: Dosing Schedule and Regimen Modification [vean> [wise] wese | weed] wees | wees | wire | weve | ween | wees | wees | wea | Whos 2q8 ° x ° xX ° x ° x ° x ° - Xe ° ° i i = @DRM: Interval Shortening During Years 1 and 2 >DRM: Interval Extension During Year 2 enteriaronintewalishonening Criteria
Slide 5: Patient Disposition, Baseline Demographics, and Disease Characteristics
Patient Disposition, Baseline Demographics, Randomized, n and Disease Characteristics oS @ @& ©@ Treated, n Completed Week 48, n (%) 1012 1009 316 (94.0) 937 (92.7) Completed Week 96, n (%) Age, years. 309 (91 286 (84: 7 74.2 (8.8) 291 (86.4) 74.7 (7.9) 312 (92.3) 292 (86.4) 74.5 (8.5) 869 (85.9) 74
Slide 6: BCVA Outcomes
BCVA Outcomes BCVA Change from BL (LS Means)? Week 48 Week 96 Week 48 +7.0 | +6.6 +6.1 | +5.6 Week +5.9 | +5.5 4 8 12 16 20 24 28 32 36 40 44 48 52 56 60 64 68 72 76 80 84 88 92 96 (ETDRS letters) Absolute BCVA (Observed Values) ol fo} Week 48 Week 96 2q8 | 66.5 | 66.5 Mes 8q12 | 66.9 | 66.6 Week 8q
Slide 7: Central Subfield Thickness
Central Subfield Thickness Absolute CST (Observed Values)? Week 48 5 Week 96 LS Mean Change from BL! LS Mean Change from BL® -136 298 -147 298 -147 8q12 -152 8q12 -147 8q16 -149 8q16 FAS: 28 n=336; 8412 n=335; 8q16 n=338 (at BL). “Observed values (data post-ICE were censored). LS mean values (data p
Slide 8: Dosing Interval Extension in Year 2
Dosing Interval Extension in Year 2 aN Last Completed Last Assigned mg8 mqi2 mqi6é mq20 mq8 mqi2 mqi6 mq20 mq24 25%° 16% Proportion of patients (%) x a £ re & = o a — is} c 2 = [s} rom ° SJ ja Randomized to Randomizedto Randomized to Randomized to 8q12 at BL (n=291)> 8916 at BL (n=292)> 8q12 at BL (
Slide 9: Dosing Intervals ≥q20 Were Assigned to ~50% of Patients on 8 mg by Week 96
Dosing Intervals 2q20 Were Assigned to ~50% of Patients on 8 mg by Week 96 Randomized to at BL (n=291) Randomized to at BL (n=292) 87% haa last assigned dosing interval 2q12 78% haa last assigned dosing interval 2q16 Patients at c o& ro) a 048 #14 2 32 40 48 56 @& 72 8 8& & 048 16 2 32 40 48 56 64 7
Slide 10: 96-Week Safety Profile of Aflibercept 8 mg: Similar to Aflibercept 2 mg
96-Week Safety Profile of Aflibercept 8 mg: Similar to Aflibercept 2 mg 336 335 338 SAF, n Ocular Safety Ocular TEAEs, n (%)? 181 (53.9) 171 (51.0) 174 (51.5) 345 (51.3) Patients with IOI, n (%)2" 7 (2.1) 6 (1.8) 3 (0.9) 9 (1.3) Pre-injection IOP increase from baseline 210 mania, n(%)° 11 (3.3) 8 (2
Slide 11: PULSAR: 96-Week Results
PULSAR: 96-Week Results Aflibercept 8 mg groups achieved similar BCVA gains compared with the aflibercept 2 mg group at Week 96 Anatomic improvements in PULSAR for aflibercept 8 mg were maintained over time through Week 96 At Week 96, 78% of patients randomized to receive aflibercept 8q16 achieved =
Slide 12: Thank you!
nAMD Thank you!