Vabysmo Receives FDA Approval
Hello Everyone, Dr. Steve Ferrucci here talking AMD with Visible Genomics.
On Friday, January 28th, the Food and Drug Administration (FDA) approved Vabysmo™ (Faricimab, Genentech) , a bispecific antibody for the treatment of wet-age related macular degeneration (AMD) as well as diabetic macula edema (DME). Faricimab is the first and only FDA approved drug to target two specific pathways, Angiopoietin -2 (Ang-2) as well as VEGF-A, both of which have a significant role in eye disease.
The idea is that by targeting two separate pathways that have been shown to contribute to AMD (as well as DME), - VEGF which is targeted by both Lucentis and Eylea, as well as Ang-2, which is novel to this drug- better results could be obtained. The studies went on to support this, showing that Faricimab could be injected less frequently than either Eylea or Lucentis, while still achieving excellent results. The TENYA and LUCERNE studies, which evaluated patients with AMD, showed that almost half of the patients receiving Faricimab could successfully extend treatment out to 4 months, with similar results to those patients treated with Eylea every 8 weeks.
The advantages are significant. Fewer injections needed translates to less treatment burden for patients, thereby making it more convenient with less treatments. In turn, this should increase patient compliance. It also paves the way for additional drugs in the pipeline by expanding beyond the “only anti-VEGF” treatment for these patients, which has been the mainstay of treatment for more than a decade. Lastly, it gives the retinal specialists with more option for patients, perhaps even those that did not respond to previous treatments.
AVONELLE X and RHONE X extension studies are currently underway to determine the long-term safety and efficacy of Faricimab for the treatment of AMD and DME, respectively. Further additional studies-CAMINO and BALATON- are currently investigating Faricimab in patients with macula edema following retinal vein occlusion.
It will be interesting to see over the next several months how this novel drug is incorporated into the AMD treatment paradigm, and how the real-life results compare to the clinical studies. Stay tuned…
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