Genentech, a member of Roche Group, released positive, topline and long-term data from the BALATON and COMINO phase 3 clinical trials 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.
Refresh me on Vabysmo.
FDA approved (in 2022) as the first bispecific antibody, Vabysmo is indicated to be administered via intravitreal injection for patients with neovascular (wet) age-related macular degeneration (AMD) and diabetic macular edema (DME).
Click here for a rundown.
Now these 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 Vabysmo (6.0 mg) or aflibercept (2.0 mg) for 20 weeks.
For weeks 24-72, all patients were administered Vabysmo (6.0 mg) up to every 4 months.
And what was measured?
Both trials’ primary endpoint was change in best-corrected visual acuity (BCVA) from baseline at 24 weeks.
Gotcha. So what did previous data 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.
See here for details from our coverage.
Now this new data.
The extended data tracked patients in both studies from weeks 24-72 with a treat-and-extend dosing regimen that enabled patients’ treatment intervals to be tailored based on their individual response to the treatment.
Go on …
Of the patients receiving Vabysmo, their treatment intervals were extended up to every 4 months while still maintaining visual gains previously reached within the first 24 weeks of the trials, according to Genentech.
How about the effect on retinal fluid?
Per the company, “Vabysmo continued to show robust and sustained drying of retinal fluid from baseline up to week 72.”
This was measured via a reduction in central subfield thickness (CST).
So overall?
Overall, Genentech reported Vabysmo was generally well-tolerated in both studies, with a safety profile consistent with the previous trial data.
And the significance?
According to Genentech’s CMO and Head of Global Product Development Levi Garraway, MD, PhD, the BALATON and COMINO trials are the first RVO trials to show vision maintenance and anatomical improvements up to 72 weeks in both CRVO and BRVO.
Give me the bigger picture.
If approved, RVO would be the third indication for Vabysmo.