European Commission issues approval for faricimab (Vabysmo) for treatment of retinal vein occlusion
In a press release, Roche noted that up to 60% of patients were able to extend treatment intervals to 3 or 4 months
The approval "could have a significant impact for people who have retinal vein occlusion." Image credit: ©Africa Studio – stock.adobe.com
In a press release, Roche announced that the European Commission (EC) has approved faricimab (Vabysmo) for the treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (RVO). This third indication applies to branch RVO (BRVO) or central RVO (CRVO). The approval follows a positive CHMP opinion at the end of June for faricimab for this indication. Faricimab is also approved for neovascular age-related macular degeneration (nAMD) and diabetic macular oedema).1
The approval is based on results from the global Phase III BALATON (NCT04740905) and COMINO (NCT04740931) trials, which were randomly assigned, multicentre, double-masked studies that evaluated the efficacy and safety of faricimab compared to aflibercept. The BALATON study was conducted in 553 patients with branch RVO. The COMINO study was conducted in 729 patients with central retinal or hemiretinal vein occlusion.
For the first 20 weeks, patients were randomly assigned 1:1 to receive 6 monthly injections of either faricimab (6.0 mg) or aflibercept (2.0 mg). From weeks 24 to 72, all patients received faricimab (6.0 mg) up to every 4 months using a personalised dosing regimen and treat-and-extend approach.
The primary endpoint of each study was the change in best-corrected visual acuity from baseline at 24 weeks. Secondary endpoints included change in central subfield thickness (CST) from baseline over time up to 24 weeks. Both studies met their primary endpoint. The average vision gains from baseline were similar between the two treatments in both studies. A secondary endpoint demonstrated2 that faricimab achieved "rapid and robust drying of retinal fluid, as measured by reduction in CST from baseline." In the latest press release, Roche also noted that “longer-term data up to 72-weeks showed that nearly 60% of people receiving Vabysmo in BALATON and nearly 48% of people in COMINO were able to extend their treatment intervals to 3 or 4 months apart.”1
Professor Frank Holz, chairman and professor, Department of Ophthalmology, University of Bonn, Germany, commented on the impact RVO has on patients’ quality of life. “People with retinal vein occlusion have limited treatment options which require regular clinic visits,” he said.1 “This approval could have a significant impact for people who have retinal vein occlusion and their caregivers, who together have to navigate the devastating impact of their disease on their ability to drive, read, socialise, travel and pursue hobbies.”
Faricimab is a bispecific antibody engineered to target and inhibit two signalling pathways linked to a number of vision-threatening retinal conditions. The agent neutralisies angiopoietin-2 and vascular endothelial growth factor-A. To date, faricimab is approved in 95 countries globally including the EU, UK, US and Japan.
References
European Commission approves Roche’s Vabysmo for treatment of retinal vein occlusion (RVO). Roche. Press release. Published 30 July 2024. Accessed 31 July 2024. https://www.roche.com/media/releases/med-cor-2024-07-30
Hayes H. EMA issues positive CHMP opinion for faricimab (Vabysmo) in third indication retinal vein occlusion. Ophthalmology Times Europe. Published 2 July, 2024. Accessed 31 July, 2024. https://europe.ophthalmologytimes.com/view/ema-issues-positive-chmp-opinion-for-faricimab-vabysmo-in-third-indication-retinal-vein-occlusion
