Roche announces Vabysmo data suggests greater retinal drying vs. aflibercept

Roche announced that post-hoc data indicate treatment with Vabysmo led to greater and faster drying of retinal fluid with fewer injections compared to aflibercept in neovascular or ‘wet’ age-related macular degeneration, or nAMD. In diabetic macular edema, or 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. The analyses from the phase III TENAYA and LUCERNE, or nAMD, and YOSEMITE and RHINE, or DME, studies were shared at the 2023 Association for Research in Vision and Ophthalmology, or ARVO, annual meeting, held from 23-27 April in New Orleans, United States. Vabysmo is the first bispecific antibody for the eye and is currently approved in 60 countries to treat nAMD and DME, with more than 800,000 Vabysmo doses distributed globally. A post-hoc analysis of pooled data from the head-to-head dosing period of the phase III TENAYA and LUCERNE studies in nAMD showed: Vabysmo reduced retinal fluid from baseline compared to aflibercept, as measured by reduction in central subfield thickness, or CST. At 12 weeks, CST reductions were 145 microm in the Vabysmo arm and 133 microm in the aflibercept arm. A larger proportion of Vabysmo patients had absence of retinal fluid at 12 weeks versus aflibercept, as measured by subretinal and intraretinal fluid. Absence of retinal fluid, as measured by absence of SRF and IRF observed in 75% of patients in each treatment arm, occurred at eight weeks with Vabysmo versus 12 weeks with aflibercept, corresponding to a fewer number of injections for Vabysmo patients versus aflibercept. A post-hoc analysis of pooled two-year data from the phase III 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 less than325 microm observed in 75% of patients in each treatment arm, occurred at 20 weeks with Vabysmo versus 36 weeks with aflibercept – a difference of nearly four months. Absence of retinal fluid, as measured by absence of IRF observed in 50% of patients in each treatment arm, occurred more than eight 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 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.11 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 had resolution of leakage versus aflibercept at 16 weeks.