Faricimab Maintains Vision Improvement, Extends Intervals for RVO in Phase 3 Trials

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New topline, long-term results from the global phase 3 BALATON and COMINO trials showed the maintenance of vision improvement with faricimab-svoa (Vabysmo) treatment for macular edema due to branch and central retinal vein occlusion (RVO).¹

Treatment with faricimab-svoa led to maintained vision improvements with extended intervals of up to every 4 months in patients with branch or central RVO, as well as sustained anatomical improvements, according to a news release from Genentech published on October 9.

“These are the first RVO trials to show vision maintenance and anatomical improvements up to 72 weeks in both central and branch RVO,” said Levi Garraway, MD, PhD, chief medical officer and head of global product development at Genentech, in the release.¹

From weeks 24 to 72, all participants across BALATON and COMINO received faricimab-svoa using a treat-and-extend dosing regimen, allowing for the tailoring of treatment intervals according to individual responses. Those treated with faricimab-svoa extended their treatment intervals up to every 4 months while maintaining vision gains achieved in the first 24 weeks of both trials.

Previously, both trials met their primary endpoint at 24 weeks, with faricimab-svoa showing non-inferior visual acuity gains compared to aflibercept. In BALATON, the vision gains were reported as +16.9 eye chart letters in the faricimab-svoa arm and +17.5 letters in the aflibercept arm at 24 weeks. In COMINO, vision gains were +16.9 letters in the faricimab-svoa arm and +17.3 letters in the aflibercept arm at 24 weeks.²

The news release also indicated faricimab-svoa continued to demonstrate anatomical improvements with robust and sustained improvement of retinal fluid from baseline up to 72 weeks, as measured by a reduction in central subfield thickness (CST).¹

Previously, at 24 weeks, in BALATON, the CST reductions were -311.4μm in the faricimab-svoa arm and -304.4μm in the aflibercept arm; in COMINO, the CST reductions were -461.6μm in the faricimab-svoa arm and -448.8μm in the aflibercept arm.²

The release noted this is the first time both vision and anatomical improvements were maintained for more than a year using a personalized treat-and-extend dosing regimen in both global phase 3 branch and central RVO trials.¹ Safety results indicated faricimab-svoa was generally well-tolerated and the safety profile was consistent with previous trials.

More than 1 million people in the United States and 28 million people globally are impacted by RVO, which can lead to sudden and severe loss of vision. An affected eye with a vein blockage restricts normal blood flow in the retina, leading to ischemia, bleeding fluid leakage, and macular edema. Macular edema due to RVO is generally treated with repeated intravitreal injections of anti-vascular endothelial growth factor (VEGF) agents.

Faricimab-svoa works by targeting and inhibiting 2 disease pathways linked to these vision-threatening conditions, with the neutralization of both angiopoietin-2 and VEGF-A. Each pathway is thought to contribute to vision loss by destabilizing blood vessels, causing new leaky blood vessels to form, and increasing inflammation. The levels of Ang-2 are elevated in RVO and this increased expression may drive disease progression.

Pending approval from the US Food and Drug Administration (FDA), RVO would be the third indication for faricimab-svoa, following neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME), each a leading cause of vision loss. A decision on the supplemental biologics license application is expected from the FDA in late 2023.³

“These data further support Vabysmo’s potential as a new treatment for RVO, allowing people to preserve their vision while spending less time managing their condition,” Garraway said.¹

References

1. Genentech’s Vabysmo Maintained Vision Improvements With Extended Treatment Intervals Up to Four Months for People With Retinal Vein Occlusion (RVO) in Phase III Trials. Genentech: Press Releases | Monday, Oct 9, 2023. October 9, 2023. Accessed October 10, 2023. https://www.gene.com/media/press-releases/15003/2023-10-09/genentechs-vabysmo-maintained-vision-imp.
2. Genentech: Press releases: Thursday, Feb 9, 2023. Genentech: Press Releases | Thursday, Feb 9, 2023. February 9, 2023. Accessed October 10, 2023. https://www.gene.com/media/press-releases/14983/2023-02-09/new-phase-iii-data-show-genentechs-vabys.
3. Iapoce C. FDA accepts supplemental bla for Faricimab for treatment of retinal vein occlusion. HCP Live. May 9, 2023. Accessed October 10, 2023. https://www.hcplive.com/view/fda-accepts-supplemental-bla-faricimab-treatment-retinal-vein-occlusion.