EMA issues positive CHMP opinion for faricimab (Vabysmo) in third indication retinal vein occlusion

The European Commission is expected to issue its final decision in the near future. Image credit: ©sebra – stock.adobe.com

The European Medicines Agency (EMA) issued a new opinion from its Committee for Medicinal Products for Human Use (CHMP), regarding faricimab (Vabysmo). In a press release, manufacturer Roche announced that the CHMP has adopted a positive opinion for the extension of the marketing authorisation for faricimab, to include the treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (RVO).¹

If approved, faricimab would be the first bispecific antibody treatment available in the EU for patients facing RVO. The CHMP based its decision on findings from the Phase III BALATON (NCT04740905) and COMINO (NCT04740931) studies. Following both studies, 72-week data demonstrated sustained vision improvements non-inferior to aflibercept, robust retinal drying and a safety profile consistent with previous studies.

The European Commission is expected to issue its final decision on the opinion in the near future.

Chief Medical Officer and Head of Global Product Development at Roche and Genentech, Levi Garraway, MD, PhD, said the CHMP recommendation represents an important step in the effort to prevent vision loss due to RVO throughout Europe. “Recognising the disruptive impact retinal vein occlusion can have on the everyday lives and independence of these patients, we hope that Vabysmo will offer a new treatment option that can effectively help preserve and improve their vision,” he said in a press release.¹

A previous news release² detailed results from the BALATON and COMINO trials, which were randomly assigned, multicentre, double-masked, global Phase III 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."

Faricimab is already approved in 95 countries globally including the EU and UK, as well as the US and Japan, for patients with neovascular age-related macular degeneration (nAMD) and diabetic macular oedema.¹ It has already been approved as a therapeutic for RVO in the US and Japan.

References

1. Roche’s Vabysmo gets CHMP recommendation for third indication retinal vein occlusion (RVO). Roche. Press release. Published 28 June, 2024. Accessed 2 July, 2024.

2. 2. FDA Accepts Application for Genentech’s Vabysmo for the Treatment of Retinal Vein Occlusion (RVO). Genentech. Press release. Published 8 May, 2023. Accessed 2 July, 2024. https://www.gene.com/media/press-releases/14991/2023-05-08/fda-accepts-application-for-genentechs-v