Compared to Regeneron and Bayer’s eye drug Eylea (aflibercept), Roche’s Vabysmo (faricimab) has shown better results in vision loss clinical trials. Data from two of its global trials in Balaton and Comino, it was observed that the drug had successfully met its primary endpoints in phase 3 macular edema trials.
Branch retinal occlusion (BRVO) and central retinal vein occlusion (CRVO) were identified as causes of macular edema, which is an illness that has the potential to lead to vision loss.
Vascular endothelial growth factor-A (VEGF-A) and Angiopoietin-2 (Ang-2) are two elements linked to vision-altering conditions and Vabysmo has been revealed as a monoclonal, bispecific antibody that can successfully hinder their production.
Although in both the Balaton and Comino trial results for gains in eye chart letters were comparable for Vabysmo and Eylea, Vabysmo had an edge over Eylea when it came to robust drying of retinal fluid from baseline and an absence of leakage.
Gains in eye chart letters for Vabysmo were +16.9 in both Balaton and Comino trials but for Eylea they were +17.5 letters in Balaton and +17.3 in Comino. All results were calculated at the end of 24 weeks.
At the end of both trials, it was also observed that patients treated with Roche’s drug were more likely to not experience blood vessel leakage in the retina. 34% of Vabysmo patients had no leakage in the BVRO group and 44% of Vabyso patients did not experience leakage in the CVRO group. For Eyle, the figures were at 21% and 30% for each trial respectively.
The two trials had a combined enrollment of approximately 1,300 participants and one dose was administered every four weeks. The studies are ongoing and presently the only side effect that has been identified is conjunctival hemorrhage, the overall safety profile for Vabysmo has been consistent with previous trials, In the future (data from weeks 24 to 72) an extended dosing interval of 4 months compared to the current to the six doses per month right now will be used.
According to the president-elect of the European Society of Retina Specialists (EURETINA) Ramin Tadayoni, “Retinal vein occlusion can cause fluid to become trapped within and under the retina, leading to rapid and severe vision loss if left untreated.”
This coupled with nAMD and DME affects around 70 million people worldwide. It is also among the top causes of vision loss.
Roche presented these latest findings to the Angiogenesis, Exudation, and Degeneration 2023 meeting. Not only this, but the clinical data will also be submitted to the U.S. Food and Drug Administration and theEuropean Medicines Agency, to support the regulatory filing of Vabysmo for macular edema.
Once approved by health authorities around the world, this would be the Vabysmo’s 3rd indication. The drug is approved for use in over 50 countries for diabetic macular edema (DME) and macular degeneration (nAMD).