Vabysmo offers visual improvements in retinal vein occlusion at 72 weeks
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Patients with retinal vein occlusion who received Vabysmo experienced visual improvements as well as extended treatment intervals at 72 weeks, according to a study.
At Angiogenesis, Exudation, and Degeneration 2024, Ramin Tadayoni, MD, PhD, presented data from the phase 3 BALATON and COMINO studies that investigated Vabysmo (faricimab, Genentech) in macular edema due to branch and central retinal vein occlusion.
“The week 72 findings from the BALATON and COMINO trials demonstrate that dual Ang-2/VEGF-A inhibition with faricimab provides disease control in patients with retinal vein occlusion,” Tadayoni said.
Five hundred fifty-three patients in the BALATON study and 729 patients in the COMINO study were randomly assigned to receive monthly injections of either faricimab or aflibercept for 6 months. In weeks 24 to 72, all patients received faricimab up to every 4 months on a treat-and-extend dosing regimen. The primary endpoint of the studies was change in best corrected visual acuity at 24 weeks.
A consistent proportion of patients gained vision or avoided loss of vision averaged over weeks 64, 68 and 73. In BALATON, 65.8% of patients who started with aflibercept before switching to faricimab gained at least 15 letters in BCVA, while 61.5% who started on faricimab gained at least 15 letters. The percentages of patients reaching this BCVA in COMINO were 59.5% and 57.6%, respectively.
At week 72, “the robust BCVA gains seen at week 24 were perfectly maintained,” Tadayoni said.
At week 68, more than 57% of patients in BALATON and more than 45% of patients in COMINO achieved dosing intervals of at least every 12 weeks.
Faricimab was well tolerated from week 24 to week 72 and demonstrated a safety profile consistent with previous data in diabetic macular edema and neovascular age-related macular degeneration, Tadayoni said.
“One of the next steps for Vabysmo will be the introduction of a prefilled syringe, which is under development,” Genentech told Healio. “This ready-to-use version should further improve the Vabysmo administration experience for both physicians and patients with retinal diseases.”
Reference:
- New long-term data for Roche’s Vabysmo show sustained retinal drying and vision improvements in retinal vein occlusion (RVO). https://www.roche.com/media/releases/med-cor-2024-02-01b. Published Feb. 1, 2024. Accessed Feb. 5, 2024.
Perspective
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These new long-term results are clinically relevant and reinforce the benefits of Vabysmo as a treatment option for people living with retinal vein occlusion (RVO).
Nearly 60% of people receiving Vabysmo in BALATON and up to 48% of people in COMINO were able to extend their treatment intervals to 3 or 4 months apart. This is important, as there is a significant treatment burden associated with frequent eye injections, and while effective, available RVO treatments are typically given every 1 to 2 months.
Additionally, patients in the studies maintained the vision gains and robust retinal drying achieved in the first 24 weeks of the studies. In the BALATON and COMINO studies, Vabysmo was well tolerated, and the safety profile was consistent with previous studies.
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Tadayoni R, et al. Faricimab in RVO: 72-week results from the BALATON and COMINO phase 3 studies. Presented at: Angiogenesis, Exudation, and Degeneration 2024; Feb. 3, 2024 (virtual meeting).
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