Genentech: New Vabysmo Data Suggest Greater Retinal Drying vs. Aflibercept in Wet AMD and DME

Genentech announced that post-hoc data indicate treatment with Vabysmo (faricimab-svoa) led to greater and faster drying of retinal fluid with fewer injections compared to aflibercept in wet age-related macular degeneration (AMD). In diabetic macular edema (DME), post-hoc data suggest Vabysmo treatment resulted in faster drying with fewer injections as well as less blood vessel leakage in the macula, the center of the retina, compared to aflibercept, according to a Genentech news release.

The analyses from the phase 3 TENAYA and LUCERNE (wet AMD) and YOSEMITE and RHINE (DME) studies were shared in three presentations at the 2023 Association for Research in Vision and Ophthalmology (ARVO) annual meeting held from April 23-27 in New Orleans. 

“Reducing retinal fluid is associated with improved vision,” Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development, said in a company news release. “These data continue to reinforce Vabysmo's ability to dry the retina and potential to make a meaningful difference for people with vision-threatening eye conditions.”  

Vabysmo is the first bispecific antibody for the eye and is currently approved in 60 countries to treat wet AMD and DME, with more than 800,000 Vabysmo doses distributed globally.

“These findings suggest that Vabysmo may provide better stability of blood vessels in the macula,” said Roger Goldberg, M.D., MBA, an ophthalmologist at Bay Area Retina Associates in Walnut Creek, California and a Vabysmo phase 3 study investigator. “Blood vessel stability may contribute to faster drying and extended durability.” 

Data on retinal drying in wet AMD

A post-hoc analysis of pooled data from the head-to-head dosing period (weeks 0-12) of the phase 3 TENAYA and LUCERNE studies in wet AMD showed:

• Vabysmo reduced retinal fluid from baseline compared to aflibercept, as measured by reduction in central subfield thickness (CST).
  • At 12 weeks, CST reductions were 145 µm in the Vabysmo arm and 
    133 µm in the aflibercept arm.
• A larger proportion of Vabysmo patients (77%) had absence of retinal fluid at 12 weeks versus aflibercept (67%), as measured by subretinal and intraretinal fluid (SRF and IRF).
• Absence of retinal fluid, as measured by absence of SRF and IRF observed in 75% of patients in each treatment arm, occurred at 8 weeks with Vabysmo versus 12 weeks with aflibercept, corresponding to a fewer number of injections for Vabysmo patients versus aflibercept.

Data on retinal drying and blood vessel leakage in DME 

A post-hoc analysis of pooled 2-year data from the phase 3 YOSEMITE and RHINE studies in DME compared time to fluid control between Vabysmo and aflibercept, as measured by absence of DME and absence of IRF. The analysis showed:

• Absence of DME, defined as CST <325 µm observed in 75% of patients in each treatment arm, occurred at 20 weeks with Vabysmo versus 36 weeks with aflibercept – a difference of nearly 4 months. 
• Absence of retinal fluid, as measured by absence of IRF observed in 50% of patients in each treatment arm, occurred more than 8 months earlier in Vabysmo patients versus aflibercept. 
  • Absence of IRF occurred at 48 weeks with Vabysmo versus 84 weeks with aflibercept, corresponding to a fewer number of injections for Vabysmo patients versus aflibercept.

A separate post-hoc analysis of pooled data from the head-to-head dosing period (weeks 0-16) of the YOSEMITE and RHINE studies evaluated blood vessel leakage in the macula – an important marker of vascular stability. Blood vessel leakage in the macula may lead to more retinal fluid, which can cause swelling and blurry vision. Results showed:

• The macular leakage area in Vabysmo patients was more than 50% smaller compared to aflibercept at 16 weeks.
  • Vabysmo reduced the macular leakage area to 3.6 mm2 from baseline compared to 7.6 mm2 with aflibercept. 
• Nearly twice as many patients (28.4%) had resolution of leakage versus aflibercept (15.2%) at 16 weeks. 

*P-values are nominal and not adjusted for multiplicity; no formal statistical conclusion should be made based on the P-values.