Last week, Roche released promising first-quarter (Q1) 2024 sales figures for VABYSMO, a vascular endothelial growth factor (VEGF) and angiopoietin-2 inhibitor for wet age-related macular degeneration (wAMD), diabetic macular oedema (DME), and macular oedema following retinal vein occlusion.
This news stands in contrast to Regeneron’s greatly anticipated high-dose EYLEA (EYLEA HD/aflibercept, 8mg), a VEGF inhibitor, entering the DME, wAMD, and diabetic retinopathy (DR) spaces in the US.
VABYSMO, which gained US Food and Drug Administration (FDA) approval in January 2022, had sales of $927m in Q1 2024.
In leading data and analytics company GlobalData’s recent Age-Related Macular Degeneration: Seven-Market Drug Forecast and Market Analysis – Update and Diabetic Macular Edema: Seven-Market Drug Forecast and Market Analysis – Update reports, the patient-based annual forecasts showed that sales of VABYSMO for 2024 were forecast to reach $3.3bn.
While Regeneron and Bayer have not yet released their sales figures for Q1, in February they reported that over the previous four months, EYLEA HD had sales of $166m.
However, sales of EYLEA in the US fell from $6.3bn in 2022 to $5.9bn in 2023.
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By GlobalData
There was anticipation that the launch of EYLEA HD may impact VABYSMO sales, and primary research with key opinion leaders (KOLs) indicated that EYLEA HD’s durability was on par or better than that seen with VABYSMO.
Nonetheless, a meta-analysis study comparing seven trials of EYLEA and VABYSMO, which is set to be presented this week at the Association for Research in Vision and Ophthalmology conference in Seattle, US, revealed that in AMD and DME patients, a greater reduction in central subfield thickness was observed with VABYSMO.
However, another contributing factor to the comparatively lower sales of EYLEA HD could also be the fact that until 1 April 2024, EYLEA HD lacked a permanent J-code – an identifying system that is essential for the billing of medications and reimbursement of drugs, and which may have hampered its prescription.
One KOL interviewed by GlobalData noted that “…a lot of the durability that you see with the high-dose aflibercept seems to be on par with that which you see with VABYSMO. So I think that it’s probably comparable to that. Now, you’re just getting, it’s basically super suppression of VEGF as opposed to a dual molecule.”
Another KOL added that the “durability in the pivotal study seems to be better for aflibercept 8mg in comparison to VABYSMO, but the inclusion criteria and the exclusion criteria were different in both of these. So it’s not really comparable.”
Thus, the results of the meta-analysis mentioned by Roche are highly anticipated, given the difficulty in comparing trials for VABYSMO and EYLEA HD.
In addition to the company’s successful start to 2024 with VABYSMO’s sales, Roche is taking extra measures to further establish itself within the wAMD, DME, and DR space.
It plans to relaunch Susvimo for wAMD in Q3 2024, which was formerly voluntarily recalled due to leakage issues, as well as filing for DME and DR as new indications for Susvimo in the second half of 2024.
If Roche’s VABYSMO continues to provide promising sales figures for the foreseeable future, in addition to the company’s anticipated relaunch of Susvimo and Suvsimo’s label expansion, Roche will have put itself on track to becoming an industry leader within the ophthalmological space.