The FDA is currently reviewing a supplemental biologics license application for Vabysmo in patients with macular edema due to retinal vein occlusion. A decision from the FDA is expected in late 2023.
Genentech’s Vabysmo (faricimab-svoa) maintained vision improvements for up to 72 weeks in patients with macular edema due to branch and central retinal vein occlusion, according to recently released long-term results from two phase 3 studies.
Retinal vein occlusion (RVO) is the second most common cause of vision loss due to retinal vascular diseases. There are two main types: branch RVO, 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 RVO, which is less common, affecting more than 4 million people worldwide, and occurs when the eye’s central retinal vein becomes blocked. Macular edema due to RVO is typically treated with repeated intravitreal injections of anti-vascular endothelial growth factor (VEGF) therapies.
Vabysmo is a bispecific antibody that targets and inhibits two disease pathways involved in retinal conditions: neutralizing angiopoietin-2 (Ang-2) and VEGF factor-A (VEGF-A). Both 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 these pathways, Vabysmo 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.
The FDA is currently reviewing a supplemental biologics license application (sBLA) for Vabysmo in patients with retinal vein occlusion. A decision from the FDA is expected in late 2023. The regulatory agency had approved Vabysmo in January 2022 to treat patients with wet age-related macular generation and diabetic macular edema. The list price is $2,190 per treatment.
In both of the phase 3 (BALATON and COMINO) studies, people with RVO who were treated with Vabysmo extended their treatment intervals up to every four months while maintaining the vision gains achieved in the first 24 weeks of the trials.
Vabysmo continued to show sustained drying of retinal fluid from baseline up to week 72. This is the first time that vision and anatomical improvements have been maintained for more than a year. In both studies, Vabysmo was generally well-tolerated and the safety profile was consistent with previous trials.
Results from weeks 24 to 72 of both studies will be presented at an upcoming medical meeting, Genentech officials said.
Data from the first 24 weeks of BALATON and COMINO were part of the sBLA for the RVO indication. These data demonstrated early and sustained vision improvement with Vabysmo, with both studies meeting their primary endpoints of non-inferior vision gains compared with Regeneron’s Eylea (aflibercept).
Additionally, both studies showed that more Vabysmo patients had an absence of blood vessel leakage in the retina compared with aflibercept patients. Blood vessel leakage in the macula may lead to more retinal fluid, which can cause swelling and blurry vision.