Can Bayer’s Eylea gain an edge over Roche’s Vabysmo in wet AMD?

Pharma News: Bayer’s Eylea (aflibercept) at a higher dosage could emerge as a worthy competitor to Roche’s Vabysmos (faricimab), a product that has rapidly gained market share for wet age-related macular degeneration (AMD) since securing PBS listing in January this year.

Real-world data indicates that wet AMD patients receive fewer anti-VEGF injections than the desired number (approximately seven) and experience worse visual outcomes compared with patients receiving fixed, frequent therapy in randomised controlled trials. Therefore, longer-acting therapies will overcome the treatment burden often associated with patient drop out, as well as other issues like macular scarring or fibrosis.

Results from Bayer/Regeneron’s phase 3 PULSAR trial in wet AMD showed that administering Eylea at the higher dose of 8 mg every 12 or 16 weeks was just as effective in vision improvement as the standard 2 mg dosage given every 8 weeks.

The PULSAR study spanning 96-weeks involved over 1,000 patients with treatment-naïve wet AMD (also called neovascular age-related macular degeneration (nAMD)). The study revealed promising results regarding the efficacy of Eylea at the higher dose. Administered at 8 mg every 12 or 16 weeks, the therapy demonstrated noninferiority in vision gains when compared to the standard 2 mg dosage given every 8 weeks. Eighty eight percent (88%) of participants achieved a dosing interval of 12 weeks or more by the study’s conclusion, with 78% maintaining this interval consistently over the two-year period. Moreover, 71% met extension criteria for even longer dosing intervals, including 47% for ≥20-week intervals and 28% for 24-week intervals, demonstrating the potential for extended treatment intervals with this higher dose regimen.

Comparatively, the two-year data from Roche’s Susvimo Archway study showed that a large proportion of Vabysmo patients can be kept on 12 weekly treatment (14.7%) and 16 weekly treatment (63.1%), resulting in the published 77.8% combined data. 

Additionally, earlier this year, data from the phase 3 BALATON and COMINO studies indicated that Roche’s Vabysmo showcased an advantage over Eylea in retinal vein occlusion (RVO), revealing reduced blood vessel leakage in the retina. This advantage extends to diabetic macular oedema (DME) and AMD, showcasing a drier retina with decreased swelling and fluid, which typically translates to clearer vision.

In response, Bayer stated, “The Vabysmo studies versus Eylea are non-inferiority studies, and Vabysmo has yet to demonstrate superiority over Eylea in the treatment of diabetic macular oedema, wet age macular degeneration, and retinal vein occlusion.”

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