Positive topline phase 3 results show faricimab-svoa improved vision for people living with retinal vein occlusion

Genentech announced this week that faricimab-svoa (Vabysmo) achieved its primary endpoint of non-inferiority compared to aflibercept in RVO in the BALATON and COMINO clinical trials.

Genentech, a member of the Roche Group, this week announced positive topline results from two global Phase III studies, BALATON and COMINO, evaluating the first and only bispecific antibody for the eye, faricimab-svoa (Vabysmo), in macular edema due to branch and central retinal vein occlusion (BRVO and CRVO). RVO is a vision-threatening condition that impacts more than 1 million people in the United States.

Both studies met their primary endpoints, showing that people with macular edema due to BRVO and CRVO receiving faricimab-svoa injections every four weeks, for up to 24 weeks, achieved non-inferior visual acuity gains compared to those receiving aflibercept injections every four weeks.

“These encouraging data demonstrate that Vabysmo could potentially provide a new treatment option for people living with retinal vein occlusion, a serious retinal vascular condition that can lead to irreversible vision impairment or vision loss,” said Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development. “Today’s results add to the extensive evidence supporting Vabysmo’s efficacy in treating multiple types of retinal conditions. We look forward to submitting these data to regulatory authorities.”

Faricimab-svoa also showed rapid drying of retinal fluid from baseline through week 24, as measured by reduction in central subfield thickness.

In both studies, faricimab-svoa was generally well tolerated. The safety profile was consistent with previous trials.

Detailed results will be presented at an upcoming medical meeting and submitted to regulatory authorities around the world.

The company also noted that faricimab-svoa targets and inhibits two disease pathways linked to a number of vision-threatening retinal conditions by neutralizing angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A). While research is underway to better understand the role of the Ang-2 pathway in retinal disease, Ang-2 and VEGF-A are thought to contribute to vision loss by destabilizing blood vessels, which may cause new leaky blood vessels to form and increase inflammation. By blocking pathways involving Ang-2 and VEGF-A, faricimab-svoa is designed to stabilize blood vessels. The level of Ang-2 is elevated in RVO and it is thought that increased Ang-2 expression drives disease progression.

To date, faricimab-svoa is approved in more than 40 countries around the world, including the United States, Japan, the United Kingdom, and the European Union, for people living with wet, or neovascular, age-related macular degeneration (AMD) and diabetic macular edema (DME). Fariciamb-svoa’s long-term efficacy and safety in wet AMD and DME has been demonstrated by two-year data from four large, global studies involving more than 3,000 participants. Faricimab-svoa is the only injectable eye medicine approved for wet AMD and DME by the FDA with the option for treatments from one to four months apart in the first year following four initial monthly loading doses, based on evaluation of the patient’s anatomy and vision outcomes. Globally, more than 165,000 faricimab-svoa doses have been distributed for treatment of these conditions to date. RVO, wet AMD and DME together affect around 3 million people in the United States and are among the leading causes of vision loss.

About Retinal Vein Occlusion

Retinal vein occlusion (RVO) is the second most common cause of vision loss due to retinal vascular diseases. It affects more than 1 million people in the U.S., mainly those aged 50 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. 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 injection of anti-vascular endothelial growth factor therapies. There are two main types of RVO: branch retinal vein occlusion (BRVO), which affects an estimated 887,000 people in the U.S. and occurs when one of the four smaller “branches” of the main central retinal vein becomes blocked; and central retinal vein occlusion (CRVO), which is less common, affecting an estimated 265,000 people in the U.S., and occurs when the eye’s central retinal vein becomes blocked.

About the BALATON and COMINO Studies

BALATON (NCT04740905) and COMINO (NCT04740931) are two randomized, multicenter, double-masked, global Phase III studies evaluating the efficacy and safety of faricimab-svoa compared to aflibercept. For the first 20 weeks, patients are randomized 1:1 to receive six monthly injections of either faricimab-svoa (6.0 mg) or aflibercept (2.0 mg). From weeks 24-72, all patients receive faricimab-svoa (6.0 mg) up to every four months – according to a personalized treatment interval dosing regimen – using a treat-and-extend approach.

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

The primary endpoint of each study is the change in best-corrected visual acuity (BCVA) from baseline at 24 weeks. Secondary endpoints include change in central subfield thickness from baseline over time up to week 24.