Slide 1: Aflibercept 8 mg in Retinal Vein Occlusion: Primary Endpoint Results from the QUASAR study
quasa Aflibercept 8 mg in Retinal Vein Occlusion: Primary Endpoint Results from the QUASAR study Richard Gale,’ on behalf of the QUASAR group ‘University of York and Scarborough Teaching Hospital NHS Foundation Trust, York, UK Presented at the Angiogenesis Meeting 2025, Virtual Edition, February 8,
Slide 2: Disclosures
Disclosures aNasa \ Richard Gale is a consultant for AbbVie, Allergan, Apellis, Astellas, Bayer, Biogen, Boehringer Ingelheim, Novartis, Ocular Therapeutix, Roche, and Santen, and conducts research for Bayer, Novartis, and Roche The ongoing QUASAR trial (NCT05850520) is sponsored by Bayer AG (Leverk
Slide 3: QUASAR Study Design
QUASAR Study Design Multicenter, randomized, double-masked study in patients with treatment-naive macular edema secondary to RVO Randomized at baseline 1 (2q4) : 1 (8q8/3) : 1 (8q8/5) 204 8q8/3 8q8/5 Aflibercept 8 mg every 8 weeks Aflibercept 8 mg every 8 weeks after 3 initial monthly injections? af
Slide 4: QUASAR: Dosing Schedule Regimen Modification Through Week 36
QUASAR: Dosing Schedule Regimen XX. Modification Through Week 36 (quasa PAI xX T&E DRM for Interval Shortening DRM for Interval Extension Dosing interval shortened by 4 weeks if the last dosing Dosing interval extended by 4 weeks starting at Week 32 interval was >4 weeks and below criteria are met a
Slide 5: Key Inclusion/Exclusion Criteria
Key Inclusion/Exclusion Criteria Inclusion Criteria Adults 218 years of age with treatment naive macular edema secondary to RVO (BRVO, CRVO, or HRVOQ) diagnosed within 16 weeks of screening visit ETDRS BCVA letter score of 73 to 24 (Snellen equivalent 20/40 to 20/320) Decrease in BCVA determined to
Slide 6: QUASAR Study Sites
QUASAR Study Sites QUASAR is a global study conducted in 237 sites in 27 countries Australia China Japan Republic of Korea Malaysia - Thailand Austria Hungary \ Poland Bulgaria Estonia Israel Portugal Switzerland France Italy Serbia Czech Republic UK Lithuania Slovakia Germany Georgia Latvia Turkey
Slide 7: Patient Disposition at Week 36
Patient Disposition at Week 36 Randomized, n 302 294 298 894 Treated 301 (99.7) 293 (99.7) 298 (100) 892 (99.8) Completing Week 36 287 (95.0) 278 (94.6) 273 (91.6) 838 (93.7) Discontinued before Week 36 15 (5.1) 25 (8.4) 54 (6.0) Reasons for discontinuation Withdrawal by subject d 8 (2.7) 16 (5.4) 3
Slide 8: Baseline Demographics and Disease Characteristics
Baseline Demographics and Disease Characteristics 2q4 8q8/3 8q8/5 Total (n=301) (n=293) (n=298) (n=892) Age (years) 65.9 (11.7) 65.8 (11.5) 65.8 (11.5) 65.9 (11.6) Female, n (%) 144 (47.8) 136 (46.4) 146 (49.0) 426 (47.8) Race, n (%) Asian 101 (33.6) 91 (31.1) 97 (32.6) 289 (32.4) Black or African A
Slide 9: Primary Endpoint Met: Non-inferior BCVA Gains for Both 8q8 Groups Compared with 2q4
Primary Endpoint Met: Non-inferior BCVA Gains for Both 8q8 Groups Compared with 2q4 uasan 0-204 (n=301) = 8q8/3 (n=293) =k 8q8/5 (n=298) +18.3 8qG/6 +17.5 294 +17.4 8q8/3 a (ETDRS letters) ry LS mean change from Difference in LS 1-sided test for non-inferiority Absolute mean BCVA BL at Week 36 means
Slide 10: Early, Robust Reductions in CRT Maintained Through Week 36
Early, Robust Reductions in CRT Maintained Through Week 36 Week Absolute mean CRT. pm) at Week 364 257 258 259 -370 8q8/5 -371 8q8/3 -371 2q4 = iS = = a oa = ° & = ja oO £ o a c io o£ oO c i] o — n a -e2q4 (n=301) -m-8q8/3 (n=293) -&-8q8/5 (n=298) Full analysis set. LS means were generated using a m
Slide 11: Most Patients in 8q8 Groups Maintained Q8 Dosing Interval Through Week 36
Most Patients in 8q8 Groups Maintained Q8 Dosing Interval Through Week 36 asal Dosing Interval Key #Q4 #Q8 8q8/3 8q8/5 (n=293) (n=298) / or criteria > Dosing interval shortened by 4 weeks if last dosing interval was >4 weeks and the below criteria are met at a dosing visit: + BCVA loss >5 letters fr
Slide 12: Last Assigned Dosing Interval at Week 36
Last Assigned Dosing Interval at Week 36 SNS 2q4 8q8/3 8q8/5 Dosing Interval Key (n=287) (n=273) = Q48Q88 Q12 6.6% Mean number of active injections through Week 36# Per DRM criteria, dosing interval extension was not 2q4 8q8/3 8q8/5 . i. el a a possible in the 8q8/5 8.5 6.0 67 group until Week 40 Pa
Slide 13: Ocular and Non-Ocular Safety Through Week 36
Ocular and Non-Ocular Safety Through Week 36 8q8/3 8q8/5 (n=293) (n=298) Ocular TEAEs, n (%) 98 (32.6%) 117 (39.9%) 97 (32.6%) 214 (36.2%) Ocular SAEs, n (%) 8 (2.7%) 4 (1.4%) 4 (1.3%) 8 (1.4%) (1.3%) 2 (0.7%) 1 (0.3%) 3 (0.5%) (0.3%) 0 0 Eye inflammation (0.3%) ie} ie} Iritis 0 1 (0.3%) 1 (0.2%) Uv
Slide 14: QUASAR: Primary Endpoint Met
QUASAR: Primary Endpoint Met Aflibercept 8 mg groups achieved robust visual outcomes and non-inferior BCVA gains with fewer injections compared with the aflibercept 2 mg group at Week 36 Most patients in the aflibercept 8 mg groups maintained their assigned Q8 intervals through Week 36 Early, robust