• 31 Jul 2024
• Admin
• News Article

Roche’s Vabysmo Receives European Commission Approval for Treatment of Retinal Vein Occlusion

Overview

Roche announced that the European Commission (EC) has approved Vabysmo (faricimab) for the treatment of visual impairment due to macular edema secondary to retinal vein occlusion (RVO, branch RVO or central RVO).

Vabysmo: Indication for RVO

• RVO is the third indication for Vabysmo in the European Union, in addition to neovascular or ‘wet’ age-related macular degeneration (nAMD) and diabetic macular edema (DME). 
• Together, the three retinal conditions affect close to 80 million people worldwide and are among the leading causes of vision loss.

Words from CMO: Roche

• “Vabysmo is a new treatment option for people with retinal vein occlusion in Europe that can help preserve and improve vision, with the added benefit of retinal drying,” said Levi Garraway, M.D., Ph.D., Roche’s chief medical officer and head of global product development. 
• “The efficacy and safety of Vabysmo has been well established in global clinical trials and is reinforced by a growing breadth of real-world evidence, with hundreds of thousands of people treated worldwide.”

Studies Behind Approval

The approval is based on positive results from two global phase III BALATON and COMINO studies, evaluating Vabysmo in more than 1,200 people with macular edema due to branch and central retinal vein occlusion (BRVO and CRVO).

From University of Bonn

• “People with retinal vein occlusion have limited treatment options which require regular clinic visits,” said Prof. Frank Holz, chairman and professor, Department of Ophthalmology, University of Bonn, Germany. 
• “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.”

Outcomes of Vabysmo Study

• Results demonstrated that monthly treatment with Vabysmo provided early and sustained improvement in vision in people with BRVO and CRVO, meeting the primary endpoint of non-inferior visual acuity gains at 24 weeks compared to aflibercept. 
• This was further supported by data showing Vabysmo achieved rapid and robust drying of retinal fluid. 
• Retinal drying is an important clinical measure as swelling from excess fluid in the back of the eye has been associated with distorted and blurred vision.

Additional Data

• Additional 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 three or four months apart. 
• Current available treatments for RVO are typically given every one to two months.

Safety profile: - In both studies, Vabysmo was well tolerated, and the safety profile was consistent with previous studies.

Vabysmo is the first and only bispecific antibody approved for the eye, uniquely engineered to target and inhibit two signalling pathways, which are linked to a number of vision-threatening retinal conditions, by neutralising angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A) to restore vascular stability.

Vabysmo: 1st Approval 

• Vabysmo was first approved for RVO by the United States (US) Food and Drug Administration in October 2023, and by the Japan Ministry of Health, Labour and Welfare in March 2024. 
• To date, Vabysmo is available in nearly 100 countries for people with nAMD and DME, with more than four million doses distributed globally.

About RVO

• RVO is the second most common cause of vision loss due to retinal vascular diseases. It affects an estimated 28 million adults globally, mainly those aged 60 or older, and can lead to severe and sudden vision loss. 
• The level of angiopoietin-2 (Ang-2) is elevated in RVO and it is thought that increased Ang-2 expression drives disease progression, alongside vascular endothelial growth factors (VEGF). 
• RVO typically results in sudden, painless vision loss in the affected eye because the vein blockage restricts normal blood flow in the affected retina, resulting in ischemia, bleeding, fluid leakage and retinal swelling called macular edema. 
• Currently, macular edema due to RVO is typically treated with repeated intravitreal injections of anti-vascular endothelial growth factor therapies. 
• There are two main types of RVO: 

branch retinal vein occlusion, which affects more than 23 million people globally and occurs when one of the four smaller ‘branches’ of the main central retinal vein becomes blocked; and 

central retinal vein occlusion, which is less common, affecting more than four million people worldwide, and occurs when the eye’s central retinal vein becomes blocked.

BALATON & COMINO Trials

• BALATON (NCT04740905) and COMINO (NCT04740931) were two randomised, multicentre, global phase III studies evaluating the efficacy and safety of Vabysmo (faricimab) compared to aflibercept. 
• For the first 20 weeks, patients were randomised 1:1 to receive 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.

Volunteers for Study

The BALATON study was conducted in 553 people with branch retinal vein occlusion. The COMINO study was conducted in 729 people with central retinal or hemiretinal vein occlusion.

Primary Endpoint

• 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 and drying of retinal fluid from baseline over time up to week 24.

Roche’s Programme for Vabysmo

• Roche has a robust phase III clinical development programme for Vabysmo. 
• The programme 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. 
• Roche has also 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.

About Vabysmo

• Vabysmo is the first bispecific antibody approved for the eye. It targets and inhibits two signalling pathways linked to a number of vision-threatening retinal conditions by neutralising angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A). 
• Ang-2 and VEGF-A contribute to vision loss by destabilising blood vessels, causing new leaky blood vessels to form and increasing inflammation. 
• By blocking pathways involving Ang-2 and VEGF-A, Vabysmo is designed to stabilise blood vessels. 
• Vabysmo is approved in nearly 100 countries, including the United States (US), 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 retinal vein occlusion. 
• Review by other regulatory authorities is ongoing.

Roche’s Focus

• Roche is focused on saving people’s eyesight from the leading causes of vision loss through pioneering therapies. 
• Through our innovation in the scientific discovery of new potential drug targets, personalised healthcare, molecular engineering, biomarkers and continuous drug delivery, we strive to design the right therapies for the right patients.