Ramin Tadayoni, MD, PhD: 72-Week Data on Faricimab in Retinal Vein Occlusion

New 72-week data from the global phase 3 BALATON and COMINO studies showed sustained drying and vision improvements with faricimab-svoa (Vabysmo) treatment for patients with retinal vein occlusion (RVO).¹

The long-term results showed nearly 60% of individuals with branch RVO (BRVO) receiving faricimab in BALATON and up to 48% of people with central RVO (CRVO) in COMINO were able to extend their treatment intervals to 3 or 4 months apart.

“The burden of the patient is important because they need a lot of injections during the first years. Being able to increase the interval decreases the burden a lot for the patient,” Ramin Tadayoni, MD, PhD, the head of ophthalmology at Université Paris Cité and president of EURETINA, told HCPLive. “It also shows that the drug has a high potential, because there’s a subgroup of patients who are very difficult to treat.”

Faricimab targets and inhibits angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A), two disease pathways linked to several vision-threatening retinal conditions. In October 2023, the US Food and Drug Administration approved faricimab-svoa for the treatment of macular edema following RVO.² The approval was based on 24-week primary endpoint data in the BALATON and COMINO studies.

Both the BALATON and COMINO studies evaluated the average change in best-corrected visual acuity (BCVA) change from baseline, as well as the central subfield thickness (CST), with reductions indicating improvements. Results from both studies showed the improvements and reductions in retinal fluid observed during the first 24 weeks of the studies were maintained for up to 72 weeks.¹

In BALATON, patients with BRVO receiving first-line faricimab treatment exhibited a gain of +18.1 letters, while those who switched from aflibercept to faricimab gained +18.8 letters. During the first 24 weeks of the study, the vision gains were +16.8 letters in the faricimab-treated arm and +17.5 letters in the aflibercept-treated arm.

Retinal drying data showed individuals treated with faricimab exhibited a 310.9 µm reduction in CST, while people who switched from aflibercept to faricimab saw a CST reduction of 307 µm. In the first 24 weeks, CST reductions were 314.5 µm in people treated with faricimab and 307.6 µm in those receiving aflibercept.

In COMINO, patients with CRVO receiving first-line faricimab treatment gained +16.9 letters at 72 weeks, while the switching group gained +17.1 letters. In the first 24 weeks of the study, the vision gains were +16.9 letters in the faricimab arm and +17.3 letters in the aflibercept arm.

Meanwhile, those treated with first line faricimab exhibited a 465.9 µm reduction in CST, while those switched from aflibercept experienced a 460.6 µm reduction in CST at 72 weeks. In the first 24 weeks of the study, the reductions were 462.3 µm in the faricimab arm and 447.8 µm in the aflibercept arm. Across both studies, faricimab was well-tolerated, with a consistent safety profile to previous studies.

For more insight into the 72-week results of BALATON and COMINO, watch the above video for the full interview with presenting investigator Dr. Tadayani.

Relevant disclosures for Tadayani include consulting, personal fees, and advisory boards at AbbVie, Apellis, Genentech, Inc., Iveric Bio, Novartis, Oculis, and Roche.

References

1. _{Genentech: Press releases: Wednesday, Jan 31, 2024. Genentech: Press Releases | Wednesday, Jan 31, 2024. January 31, 2024. Accessed February 1, 2024. https://www.gene.com/media/press-releases/15017/2024-01-31/new-long-term-data-for-genentechs-vabysm.}
2. _{Campbell P. Faricimab (Vabysmo) receives FDA approval for retinal vein occlusion. HCP Live. October 27, 2023. Accessed February 1, 2024. https://www.hcplive.com/view/faricimab-vabysmo-receives-fda-approval-for-retinal-vein-occlusion.}