VABYSMO was validated in two robust Phase III trials in treatment-naive patients with RVO1
BALATON/COMINO Pooled
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enrolled patients
VABYSMO treat-and-extend dosing was designed to reflect real-world practice1
Dosing interval reductions could be driven by changes observed on OCT and did not require vision to decline†
Interval Maintained‡
CST improved
Interval Extended by 4 Weeks§
CST stable
Interval Reduced by 4 Weeks⁋
CST worsened
Once reduced, the treatment interval could no longer be extended**
Once reduced, the treatment interval could no longer be extended**
BALATON is BRVO only and COMINO is CRVO/HRVO only.*From Week 24, aflibercept arm was moved to VABYSMO 6.0 mg, with treat-and-extend dosing driven primarily by changes observed on OCT to Week 72. †Reference CST was defined as the CST value when the original reference value (CST <325 µm) was achieved. Reference CST was adjusted if CST decreased by >10% from the previous reference CST for 2 consecutive study drug dosing visits and the values obtained were within 30 µm. The CST value obtained at the latter visit served as the new reference CST. ‡Regardless of BCVA increase or decrease, intervals were maintained. §Unless CST decreased by ≤20% and accompanied by ≥10-letter decrease from reference BCVA (then interval maintained) or unless CST increase ≥10% and accompanied by BCVA decrease of ≥10-letter (then interval reduced by 4 weeks). ⁋Unless CST increase 11-20% and accompanied by BCVA decrease of <5 letters (then interval maintained). **Except for patients who were on longer intervals and were directly reduced to Q4W.
Treat early with VABYSMO for rapid vision gains, maintained over 1 year*1
Adjusted mean change in visual acuity from baseline1
BALATON (BRVO)
COMINO (CRVO/HRVO)
*VABYSMO 6.0 mg Q4W met the primary endpoint, demonstrating noninferior vision gains vs aflibercept 2.0 mg Q4W at Week 24 in BALATON and COMINO. Values are calculated as mean change from baseline at Week 24. †Adjusted mean BCVA change from baseline, averaged over Week 64, 68 and 72.
Early and sustained CST reductions with VABYSMO through Week 72*1
Adjusted mean CST change from baseline1
BALATON (BRVO)
COMINO (CRVO/HRVO)
*Primary endpoint of Phase III studies was non-inferiority in BCVA vs. aflibercept 2.0 mg Q8W for nAMD and DME, and aflibercept 2.0 mg Q4W for RVO. Values are calculated as mean change from baseline at week 24. †Adjusted mean CST change from baseline, averaged over Week 64, 68 and 72.
More patients achieve resolution of macular leakage* with VABYSMO vs. aflibercept in the matched dose phase1
Proportion of patients with absence of macular leakage at 24 weeks*1
BALATON (BRVO)
COMINO (CRVO/HRVO)
*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. Macular leakage area within ETDRS grid was assessed by the reading centre based on FA images obtained at baseline and predefined follow-up intervals. Absence is defined as area of leakage within the macula of 0 mm2 per FA. The prespecified exploratory analysis only included patients with evaluable FA data (BALATON: aflibercept, N=224; faricimab, N=229; COMINO: aflibercept, N=297; faricimab, N=311. †P-values (for superiority testing) are nominal and not adjusted for multiplicity; no formal statistical conclusion should be made based on the P-values.
VABYSMO has a favourable benefit-risk profile demonstrated in 6 Phase III trials and in real-world settings*1–4
In Phase III trials:1-3
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 trials4
*As of January 2024, >3 million doses have been distributed worldwide.5 †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 maintained over 1 year*1
Adjusted mean change in visual acuity from baseline1
BALATON (BRVO)
COMINO (CRVO/HRVO)
*VABYSMO 6.0 mg Q4W met the primary endpoint, demonstrating noninferior vision gains vs aflibercept 2.0 mg Q4W at week 24 in BALATON and COMINO. Values are calculated as mean change from baseline at week 24. †Adjusted mean BCVA change from baseline, averaged over Week 64, 68 and 72.
Early and sustained CST reductions with VABYSMO through Week 72*1
Adjusted mean CST change from baseline1
BALATON (BRVO)
COMINO (CRVO/HRVO)
*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. Values are calculated as mean change from baseline at week 24. †Adjusted mean CST change from baseline, averaged over Week 64, 68 and 72.
More patients achieve resolution of macular leakage* with VABYSMO vs. aflibercept in the matched dose phase1
Proportion of patients with absence of macular leakage at 24 weeks*1
BALATON (BRVO)
COMINO (CRVO/HRVO)
*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. Macular leakage area within ETDRS grid was assessed by the reading center based on FA images obtained at baseline and predefined follow-up intervals. Absence is defined as area of leakage within the macula of 0 mm2 per FA. The prespecified exploratory analysis only included patients with evaluable FA data (BALATON: aflibercept, N=224; faricimab, N=229; COMINO: aflibercept, N=297; faricimab, N=311. †P-values (for superiority testing) are nominal and not adjusted for multiplicity; no formal statistical conclusion should be made based on the P-values.
VABYSMO has a favourable benefit-risk profile demonstrated in 6 Phase III trials and in real-world settings*1–4
In Phase III trials:1,5,6
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 trials7
*As of January 2024, >3 million doses have been distributed worldwide.5 †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
- Tadayoni R, et al. Presented at Angiogenesis 2024, presentation available at medically.roche.com.
- Khanani AM, et al. Ophthalmology. 2024;19:S0161-6420(24)00134-9.
- Wong TY, et al. Ophthalmology. 2024;131(6):708-723.
- Lim J, et al., Presented at Angiogenesis 2024.
- Singh R, et al. Presented at BRAVS 2024.
