Roche announced today that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for extending the marketing authorization of Vabysmo® (faricimab) to include the treatment of visual impairment due to macular edema secondary to retinal vein occlusion (RVO). A final decision from the European Commission is expected soon.
“This CHMP recommendation represents an important step towards bringing Vabysmo to even more patients living with vision loss in Europe,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “Recognizing 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.”
The CHMP decision is based on full 72-week data from the Phase III BALATON and COMINO studies, which evaluated Vabysmo in more than 1,200 people with macular edema due to branch and central RVO (BRVO and CRVO). In both studies, Vabysmo demonstrated early and sustained vision improvements non-inferior to aflibercept, along with robust retinal drying. Vabysmo was well tolerated, with a safety profile consistent with previous studies. Current treatments for RVO are typically administered every one to two months.
Vabysmo was first approved for RVO by the United States Food and Drug Administration in October 2023 and by the Japan Ministry of Health, Labour and Welfare in March 2024. It is also approved in more than 95 countries worldwide for neovascular or ‘wet’ age-related macular degeneration (nAMD) and diabetic macular edema (DME).
Roche has the broadest retina pipeline in ophthalmology. Led by science and informed by insights from people with eye conditions, Roche is committed to saving people’s eyesight from the leading causes of vision loss through pioneering treatments.
RVO is the second most common cause of vision loss due to retinal vascular diseases, affecting an estimated 28 million adults globally, mainly those aged 60 or older. It can lead to severe and sudden vision loss. Elevated levels of angiopoietin-2 (Ang-2) in RVO are thought to drive disease progression. RVO typically results in sudden, painless vision loss in the affected eye due to vein blockage, which restricts normal blood flow in the retina, resulting in ischemia, bleeding, fluid leakage, and retinal swelling (macular edema). Currently, macular edema due to RVO is treated with repeated intravitreal injections of anti-vascular endothelial growth factor therapies. There are two main types of RVO: branch RVO, affecting more than 23 million people globally, and central RVO, affecting more than four million people worldwide.
BALATON (NCT04740905) and COMINO (NCT04740931) were two randomized, multicenter, global Phase III studies evaluating the efficacy and safety of Vabysmo®️ (faricimab) compared to aflibercept. For the first 20 weeks, patients received six monthly injections of either Vabysmo (6.0 mg) or aflibercept (2.0 mg). From weeks 24-72, all patients received Vabysmo (6.0 mg) up to every four months using a treat-and-extend dosing regimen.
The BALATON study included 553 people with branch retinal vein occlusion, while the COMINO study included 729 people with central retinal or hemiretinal vein occlusion.
The primary endpoint of each study was the change in best-corrected visual acuity from baseline at 24 weeks. Secondary endpoints included changes in central subfield thickness and drying of retinal fluid from baseline over time up to week 24.
Roche has a robust Phase III clinical development program for Vabysmo. This includes AVONELLE-X (NCT04777201), an extension study of TENAYA (NCT03823287) and LUCERNE (NCT03823300), evaluating the long-term safety and tolerability of Vabysmo in neovascular or ‘wet’ age-related macular degeneration (nAMD), and RHONE-X (NCT04432831), an extension study of YOSEMITE (NCT03622580) and RHINE (NCT03622593) evaluating the long-term safety and tolerability of Vabysmo in diabetic macular edema (DME). Roche has also initiated several Phase IV studies, including the ELEVATUM (NCT05224102) study of Vabysmo in underrepresented patient populations with DME, the SALWEEN study of Vabysmo in a subpopulation of nAMD highly prevalent in Asia, and the POYANG (NCT06176352) study of Vabysmo in adult treatment-naive patients with choroidal neovascularisation secondary to pathologic myopia. Additionally, Roche has initiated the VOYAGER (NCT05476926) study, a global real-world data collection platform, and supports several other independent studies to further understand retinal conditions with a high unmet need.
Vabysmo is the first bispecific antibody approved for the eye. It targets and inhibits two signaling pathways linked to a number of vision-threatening retinal conditions by neutralizing angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A). These pathways contribute to vision loss by destabilizing blood vessels, causing new leaky blood vessels to form and increasing inflammation. By blocking Ang-2 and VEGF-A, Vabysmo is designed to stabilize blood vessels. Vabysmo is approved in more than 95 countries worldwide, including the United States, Japan, the United Kingdom, and the European Union for people living with neovascular or ‘wet’ age-related macular degeneration and diabetic macular edema, and in several countries, including the US and Japan, for RVO. Review by other regulatory authorities is ongoing.
Roche is focused on saving people’s eyesight from the leading causes of vision loss through pioneering therapies. Through innovation in scientific discovery, personalized healthcare, molecular engineering, biomarkers, and continuous drug delivery, Roche strives to design the right therapies for the right patients.
Roche has the broadest retina pipeline in ophthalmology, informed by insights from people with eye diseases. This includes gene therapies and treatments for multiple vision-threatening conditions, such as diabetic eye diseases, geographic atrophy, and autoimmune conditions like thyroid eye disease and uveitic macular edema.
Roche has brought breakthrough ophthalmic treatments to people living with vision loss. Susvimo® (previously called Port Delivery System with ranibizumab) was approved by the U.S. Food and Drug Administration in 2021. Vabysmo is approved worldwide for neovascular or ‘wet’ age-related macular degeneration and diabetic macular edema, and in several countries, including the US and Japan, for macular edema following retinal vein occlusion. Lucentis® (ranibizumab injection) was the first treatment approved to improve vision in people with certain retinal conditions.
