Genentech, a member of Roche Group, announced the results from a post hoc analysis comparing the use of faricimab-svoa (Vabysmo) to aflibercept for drying retinal fluid in two eye diseases: wet age-related macular degeneration (AMD) and diabetic macular edema (DME).
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).
It is also currently approved in 60 countries.
Click here for a rundown.
Where did this post hoc data come from?
The analysis results are from the phase 3 TENAYA (NCT03823287) and LUCERNE trials (NCT03823300) (for wet AMD) and the YOSEMITE (NCT03622580) and RHINE (NCT03622593) (for DME) trials.
Let’s talk about the wet AMD trials first.
Data from a 12-week dosing period of the TENAYA and LUCERE trials found that Vabysmo reduced retinal fluid from baseline compared to aflibercept (as measured by central subfield thickness [CST] reduction): 145 µm in the Vabysmo arm; 133 µm in the aflibercept arm.
Further, 77% of Vabysmo patients (compared to 67% aflibercept) had retinal fluid absence at 12 weeks (measured by subretinal and intraretinal fluid [SRF, IRF]).
What else?
Both arm groups were observed to have no retinal fluid in 75% of patients (at 8 weeks for Vabysmo; 12 weeks for aflibercept). For Vabysmo, this also translated to a fewer number of injections.
Now tell me about the DME trial data.
Two-year data from both trials assessed the difference between time and fluid control for Vabysmo and aflibercept (measured by DME and IRF absence) during a 16-week dosing period.
For Vabysmo patients, DME absence was noted in 75% of patients in each treatment arm (and defined as CST < 325 µm) at 20 weeks (Vabysmo) and 35 weeks (aflibercept).
Further, retinal fluid absence was noted in 50% of patients in each treatment arm; however, it occurred in Vabysmo patients 8 months earlier (48 weeks versus 85 weeks) than aflibercept.
Anything else?
One other analysis of the DME trials assessed blood vessel leakage in the macula; Vabysmo patients’ macular leakage area was observed as 50% smaller than aflibercept (at 16 weeks).
Additionally, 28.4% of Vabysmo patients had leakage resolution compared to 15.2% of aflibercept.
Take home?
The pool data findings suggest that, compared to aflibercept, Vabysmo may provide better stability for blood vessels within the macula, which, in extension, might lead to enhanced drying and extended durability.