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Pharma Update

Roche Vabysmo: Disease activity criteria chosen affect durability outcomes Vabysmo nAMD trials use vision or anatomical disease activity criteria, reflecting clinical practice¹ Different ≥Q12W disease criteria as applied to Vabysmo or aflibercept 8 mg patients* aflibercept 8mg ASRS SEATTLE Vabysmo Share of patients assigned to ≥Q12W dosing Assessment done at week 20 Share of patients assigned to ≥Q12W dosing Stringent criteria (as actually applied in our clinical trials) Treatment change if ANY criteria are met (based on criteria used in pivotal trials) 22% "OR" criteria 53% 47% Ph II CANDELA (wk 44) A OR B OR C OR D OR E 78% Less stringent criteria (post hoc analysis**) Treatment change if ALL criteria are met F AND G 4% >Q12W Q8W 96% "AND" criteria 83% >Q12W Q8W 17% Ph III PULSAR (wk 48) Ph III TENAYA/LUCERNE trial with stringent patient-centric criteria resulted in 22% of patients being allocated to Q8W dosing Using less stringent criteria, only 4% of patients would have been assigned to Q8W dosing (post hoc analysis) 1. Zarbin et al. ASRS, 2023; *Criteria: A=> 5 letters BCVA loss vs avg. BCVA over previous 2 scheduled visits, due to nAMD, B=> 10 letters BCVA loss vs highest BCVA recorded over previous 2 scheduled visits, due to nAMD; C=> 50 μm CST increase vs avg. CST over previous 2 scheduled visits; D=≥ 75 μm CST increase vs lowest CST recorded at either of previous 2 scheduled visits; E-Presence of new macular hemorrhage*, due to nAMD activity; F->5 letters BCVA loss vs week 16 BCVA; G=> 25 μm CST increase vs week 16 CST or new macular hemorrhage; **Post-hoc analysis of patients dosing eligibility at week 20, patients not actually assigned based on 'and' criteria in TENAYA/LUCERNE; This analysis is not intended as a cross-trial comparison; This analysis cannot predict whether faricimab-treated patients in TENAYA & LUCERNE would have achieved non-inferiority vs aflibercept 2mg/8mg if the treatment regimen had been modified; additional patients with a missing Week 20 assessment were considered to have met disease activity criteria and were treated Q8W; Q8W=every 8 weeks 49 49
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