VABYSMO was validated by two robust Phase III trials in treatment-naive patients with nAMD1

TENAYA/LUCERNE Pooled

1.329

enrolled patients

chart1

VABYSMO treat-and-extend dosing was designed to reflect real-world practice2–4

Dosing interval reductions could be driven by changes observed on OCT and did not require vision to decline*

Disease Activity
based on: 

CST 

or

BCVA

OR

Clinical Exam†

Interval Reduced‡

based on: 

CST 

or

BCVA

OR

Clinical Exam§

Interval Extended⁋

based on: 

CST 

or

BCVA

&

Clinical Exam§

Interval Maintained

based on:

 

If extension and reduction 

criteria were not met

Disease Activity 

based on:

CST

OR

BCVA

OR

Clinical Exam†

Interval Extended⁋

based on:

CST

AND

BCVA

and

Clinical Exam§

Disease Activity 

based on:

CST

OR

BCVA

OR

Clinical Exam†

Interval Maintained
based on:

If extension and reduction criteria were not met

*Patients were treated on fixed Q8W, Q12W or Q16W until Week 60. In Year 2, patients were assigned to treat-and-extend dosing starting at Week 60. †At Week 24 only, investigator opinion of significant nAMD activity that requires immediate treatment would qualify as active disease and trigger assignment to fixed Q12W interval. ‡Reduction by 4 or 8 weeks to a minimum interval of Q8W. If two or more criteria were met or new macular haemorrhage, the interval was reduced to Q8W. Patients reduced from Q16W to Q8W were not allowed to return to Q16W. §Investigator opinion of new macular occurred haemorrhage due to active disease would trigger assignment interval reduction. Extension by 4 weeks to a maximum of Q16W.

Treat early with VABYSMO for rapid vision gains and only 3 injections in Year 2*1

TENAYA/LUCERNE Pooled

Adjusted mean change in visual acuity from baseline1

*After Week 60 to Week 112: VABYSMO treat-and-extend phase vs aflibercept 2.0 mg Q8W fixed dosing. Based on study design, aflibercept 2.0 mg was not allowed to extend beyond Q8W dosing. †Aflibercept 2.0 mg Q8W initial dosing was 3 x monthly. ‡VABYSMO dosed up to Q16W met the primary endpoint, demonstrating noninferior vision gains vs aflibercept 2.0 mg Q8W, averaged over Week 40, 44 and 48 in both TENAYA and LUCERNE.5  §Adjusted mean BCVA change from baseline, averaged over Week 104, 108 and 112. 

VABYSMO delivers faster* drying with fewer injections vs. aflibercept6

TENAYA/LUCERNE Pooled

Time to first absence of IRF and SRF†‡6

(post hoc analysis)​

first-absence

*Based on post hoc, exploratory analysis with nominal P-value statistical analysis not adjusted for multiple testing (nominal P-value <0.05 vs. aflibercept 2.0 mg Q8W), no formal statistical conclusions can be drawn. Primary endpoint of Phase III studies was non-inferiority in BCVA vs. aflibercept 2.0 mg Q8W for nAMD and DME, and aflibercept Q4W for RVO. †Absence of retinal fluid defined as absence of IRF and SRF. IRF and SRF are as measured in the central subfield (centre 1 mm). Event is defined as the first absence of IRF and SRF after randomisation date. Patients with absence of IRF and SRF at baseline were excluded from the analysis. ‡Median number of injections required to achieve 75% cumulative incidence of absence of IRF and SRF. §HR:1.46. Stratified analyses for HR and log-rank test. Stratification factors are baseline BCVA, baseline LLD, region and study. HRs were estimated by Cox regression.

VABYSMO delivers extended durability with ~80% of patients on Q12W or Q16W treatment intervals at Year 21

TENAYA/LUCERNE Pooled

Distribution of patients achieving each treatment interval in Year 2 with VABYSMO¹

first-absence

*Primary endpoint of Phase III studies was non-inferiority in BCVA vs. aflibercept 2.0 mg Q8W for nAMD and DME, and aflibercept Q4W for RVO. Patients with evaluable data at Week 60 to Week 112 in the VABYSMO 6.0 mg up to Q16W arm. †After Week 60 to Week 112: VABYSMO treat-and-extend phase vs aflibercept 2.0 mg Q8W fixed dosing. 

VABYSMO has a favourable benefit-risk profile demonstrated in 6 Phase III trials and in real-world settings*1,7–9

In Phase III trials:1,7,8

Comparable safety profile to aflibercept 2.0 mg across nAMD, DME, and RVO†

Low rates of intraocular inflammation‡

No cases of retinal vasculitis or occlusive retinal vasculitis reported in the global cohort

Rates of targeted events in real-world studies are comparable to those observed in clinical trials9

*As of January 2024, >3 million doses have been distributed worldwide.10 †No comparison possible for Week 24 to Week 72 RVO data (BALATON/COMINO). ‡An external review of investigator reported IOI cases reported in Phase III trials found no patterns suggestive of IOI related occlusive retinal vasculitis.

Treat early with VABYSMO for rapid vision gains and extended durability over 2 years*1

TENAYA/LUCERNE Pooled

Adjusted mean change in visual acuity from baseline1

*After Week 60 to Week 112: VABYSMO treat-and-extend phase vs aflibercept 2.0 mg Q8W fixed dosing. Based on study design, aflibercept 2.0 mg was not allowed to extend beyond Q8W dosing. †Aflibercept 2.0 mg Q8W initial dosing was 3 x monthly. ‡VABYSMO dosed up to Q16W met the primary endpoint, demonstrating noninferior vision gains vs aflibercept 2.0 mg Q8W, averaged over Week 40, 44 and 48 in both TENAYA and LUCERNE.5 §Adjusted mean BCVA change from baseline, averaged over Week 104, 108 and 112.

VABYSMO delivers faster* drying with fewer* injections vs. aflibercept6

TENAYA/LUCERNE Pooled

Time to first absence of IRF and SRF†‡6

(post hoc analysis)​

*Based on post hoc, exploratory analysis with nominal P-value statistical analysis not adjusted for multiple testing (nominal P-value <0.05 vs. aflibercept 2.0 mg Q8W), no formal statistical conclusions can be drawn. Primary endpoint of Ph3 studies was non-inferiority in BCVA vs. aflibercept 2.0 mg Q8W for nAMD and DME, and aflibercept Q4W for RVO. †Absence of retinal fluid defined as absence of IRF and SRF. IRF and SRF are as measured in the central subfield (centre 1 mm). Event is defined as the first absence of IRF and SRF after randomisation date. Patients with absence of IRF and SRF at baseline were excluded from the analysis. ‡Median number of injections required to achieve 75% cumulative incidence of absence of IRF and SRF. §HR:1.46. Stratified analyses for HR and log-rank test. Stratification factors are baseline BCVA, baseline LLD, region and study. HRs were estimated by Cox regression.

VABYSMO delivers extended durability with ~80% of patients on Q12W or Q16W treatment intervals at Year 21

TENAYA/LUCERNE Pooled

Distribution of patients achieving each treatment interval in Year 2 with VABYSMO¹

nAMD q16

*Primary endpoint of Ph3 studies was non-inferiority in BCVA vs. aflibercept 2.0 mg Q8W for nAMD and DME, and aflibercept Q4W for RVO. Patients with evaluable data at Week 60 to Week 112 in the VABYSMO 6.0 mg up to Q16W arm. †After Week 60 to Week 112: VABYSMO treat-and-extend phase vs aflibercept 2.0 mg Q8W fixed dosing. 

VABYSMO has a favourable benefit-risk profile demonstrated in 6 Phase III trials and in real-world settings*1,7–9

In Phase III trials:1,7,8

Comparable safety profile to aflibercept 2.0 mg across nAMD, DME, and RVO†

Low rates of intraocular inflammation‡

No cases of retinal vasculitis or occlusive retinal vasculitis reported in the global cohort

Rates of targeted events in real-world studies are comparable to those observed in clinical trials9

*As of January 2024, >3 million doses have been distributed worldwide.10 †No comparison possible for week 24 to week 72 RVO data (BALATON/COMINO). ‡An external review of investigator reported IOI cases reported in Phase III trials found no patterns suggestive of IOI related occlusive retinal vasculitis.

References
  1. Khanani AM, et al. Ophthalmology. 2024;19:S0161-6420(24)00134-9.
  2. Heier JS, et al. Lancet. 2022;399:729–40.
  3. VABYSMO®. SmPC https://go.roche.com/Vabysmo_SmPC Accessed May 2024
  4. Khanani AM, et al. Ophthalmol Sci. 2021;1:100076.
  5. VABYSMO®. Prescribing Information. https://www.gene.com/download/pdf/vabysmo_prescribing.pdf Accessed May 2024.
  6. Chaudhary V, et al. Presented at ARVO 2023.
  7. Wong TY, et al. Ophthalmology. 2024;131(6):708-723.
  8. Tadayoni R, et al. Presented at Angiogenesis 2024, presentation available at medically.roche.com. 
  9. Lim J, et al., Presented at Angiogenesis 2024.
  10. Singh R, et al. Presented at BRAVS 2024.