VABYSMO®▼ has reached more than 100 countries with a total of over 8 million doses distributed in just 3 years.1,2
Celebrate this milestone in style and with music!
Time to first absence of DME* (post hoc analysis)3
Proportion of patients with absence of DME* at the end of Year 2 and Year 4 (post hoc analysis)3
Adjusted mean CST change† from baseline (secondary endpoint)4
Dr. Salvatore Di Lauro,
Hospital Clínico Universitario de Valladolid, Spain
Dr Harit Bhatt,
University Retina, US
Prof. Laurent Kodjikian,
University of Lyon, France
Prof. Dr Arne Viestenz,
University of Halle, Germany
Dr. Shaheer Aboobaker,
Toronto Retina Institute, Canada
VABYSMO dosed up to Q16W met the primary endpoint, demonstrating non-inferior vision gains vs. aflibercept 2.0 mg Q8W, averaged over Week 48, 52 and 56 in both YOSEMITE
and RHINE.6
VABYSMO was studied head-to-head vs. aflibercept 2.0 mg over 2 years, followed by RHONE-X, an OLE study through Year 4. In YOSEMITE and RHINE, patients were randomised to either VABYSMO Q8W, VABYSMO up to Q16W or aflibercept 2.0 mg Q8W dosing (n=1891). In RHONE-X (OLE), all patients received VABYSMO up to Q16W (n=1474). The VABYSMO up to Q16W regimen started at Week 100 for VABYSMO Q8W and aflibercept Q8W but not all patients received VABYSMO at Week 100.3,4
* Absence of DME is defined as CST <325 µm.
† Based on post hoc 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.
‡ Macular edema secondary to RVO.
CST, central subfield thickness; DME, diabetic macular edema; nAMD, neovascular age-related macular degeneration; OLE, open-label extension; Q8W, every 8 weeks; Q16W, every 16 weeks; RVO, retinal vein occlusion; SmPC, summary of product characteristics; US, United States.
References: