Genentech, a member of Roche Group, announced positive results from two phase 3 clinical trials—BALATON and COMINO—assessing the safety and efficacy of Vabysmo (faricimab-svoa) in macular edema as a result of branch and central retinal vein occlusion (BRVO and CRVO) at 24 weeks.
Tell me about Vabysmo.
Vabysmo is the first bispecific antibody that was FDA approved (in 2022) to be administered via intravitreal injection into the eye for patients with neovascular (wet) age-related macular degeneration (AMD) and diabetic macular edema (DME).
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Talk about the studies.
The BALATON (NCT04740905) and COMINO (NCT04740931) studies were randomized, multicenter, double masked, and global; 553 patients with BRVO were enrolled in the BATALON study, while 730 patients with CRVO or hemiretinal vein occlusion were enrolled in the COMINO study.
In both studies, patients randomly (1:1) received 6 monthly injections of 6 mg Vabysmo or 2 mg aflibercept for 20 weeks. For weeks 24-72, all patients were administered 6.0 mg Vabysmo up to every 4 months.
What’s the primary endpoint?
The primary endpoint for both trials included change in best-corrected visual acuity (BCVA) from baseline at 24 weeks.
What did they find?
The primary endpoint was met in both studies; non-inferior visual acuity gains were observed for Vabysmo (compared to aflibercept), while average vision gains from baseline were comparable between both Vabysmo and aflibercept.
Talk numbers.
At 24 weeks, vision gains in BALATON were +16.9 eye chart letters in the Vabysmo arm and +17.3 letters in the aflibercept arm. The patient percentage achieving a +15 letter gain was also comparable in treatment arms of both studies.
Comparable reductions in central subfield thickness (CST) were also observed in both studies; BALATON showed -311.4 μm and -304.4 μm in the Vabysmo and aflibercept arms, respectively, while COMINO showed -461.6 μm in the Vabysmo arm and -448.8 μm in the aflibercept arm.
Anything else?
In the BALATON study, 34% of Vabysmo patients exhibited an absence of blood vessel leakage in the retina compared to 21% of aflibercept patients. Similar trends were observed in the COMINO study, with 44% of Vabysmo patients and 30% of aflibercept patients.
What’s next?
Both studies are ongoing and will have data from weeks 24 to 72 to report. Results will be based on assessing Vabysmo’s potential to extend dosing intervals up to every 4 months (instead of monthly).