Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today new 72-week data from two global Phase III studies, BALATON and COMINO, evaluating Vabysmo® (faricimab) in macular edema due to branch and central retinal vein occlusion (BRVO and CRVO).1,2 Whereas available RVO treatments are typically given every one to two months, the data showed nearly 60% of people receiving Vabysmo in BALATON and up to 48% of people in COMINO were able to extend their treatment intervals to three or four months apart.1,2,3,4 In addition, patients in the studies maintained vision gains and robust retinal drying achieved in the first 24 weeks of the studies for more than one year. Retinal drying is an important clinical measure as swelling from excess fluid in the back of the eye has been associated with distorted and blurred vision.5 In both studies, Vabysmo was well tolerated and the safety profile was consistent with previous studies.
“This is the first time that vision and anatomical improvements have been maintained for more than a year in global Phase III studies for both branch and central retinal vein occlusion,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “These long-term results build on the strong clinical and real-world data reinforcing Vabysmo as an effective treatment option for people affected by retinal conditions that can cause vision loss.”
Results will be presented virtually on 3 February 2024 at Angiogenesis, Exudation, and Degeneration 2024, organised by Bascom Palmer Eye Institute in Florida, United States (US).
“The sustained vision improvements and retinal drying seen up to 72 weeks reaffirm Vabysmo as an effective treatment for retinal vein occlusion,” said Ramin Tadayoni, M.D., Ph.D., head of ophthalmology at the Cité University in Paris, France, and president of EURETINA, who is presenting the data at Angiogenesis. “More treatment options are needed to better serve people living with this condition, and these data show Vabysmo can potentially improve outcomes while reducing the number of clinic visits needed.”
Both studies evaluated the average change in best-corrected visual acuity (BCVA) score (the best distance vision a person can achieve – including with correction such as glasses – when reading letters on an eye chart) from baseline. The studies also tracked the amount of swelling in the back of the eye due to retinal fluid, as measured by central subfield thickness (CST). Reductions in CST indicate improvement. Overall, results showed the vision improvements and reductions in retinal fluid achieved in the first 24 weeks of the studies were maintained up to 72 weeks.
Results for BRVO (BALATON)1:
- Vision gains: At 72 weeks, people receiving Vabysmo as a first-line treatment gained 18.1 letters on the eye chart, while people switched from aflibercept to Vabysmo gained 18.8 letters. During the first 24 weeks, vision gains were +16.8 eye chart letters in people receiving Vabysmo and +17.5 letters in people receiving aflibercept.
- Retinal drying: At 72 weeks, people receiving Vabysmo as a first-line treatment saw a 310.9 µm reduction in retinal swelling, as measured by CST, while those switched from aflibercept to Vabysmo saw a reduction in CST of 307 µm. During the first 24 weeks of the study, CST reductions were 314.5 µm in people receiving Vabysmo and 307.6 µm in people receiving aflibercept.
Results for CRVO (COMINO)2:
- Vision gains: People receiving Vabysmo as a first-line treatment gained 16.9 eye chart letters at 72 weeks, while people switched from aflibercept to Vabysmo gained 17.1 eye chart letters. During the first 24 weeks of the study, vision gains were +16.9 eye chart letters in people receiving Vabysmo and +17.3 letters in people receiving aflibercept.
- Retinal drying: People receiving Vabysmo as a first-line treatment saw a 465.9 µm reduction in retinal swelling, as measured by CST, while those switched from aflibercept to Vabysmo saw a reduction in CST of 460.6 µm at 72 weeks. During the first 24 weeks of the study, reductions in CST were 462.3 µm in people receiving Vabysmo and 447.8 µm in people receiving aflibercept.
Vabysmo is the first and only bispecific antibody approved for the eye, uniquely engineered to target and inhibit two signalling pathways, which are linked to a number of vision-threatening retinal conditions, by neutralising angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A) to restore vascular stability.6-9
To date, Vabysmo is approved in more than 90 countries around the world for people living with neovascular or ‘wet’ age-related macular degeneration (nAMD) and diabetic macular edema (DME), with public reimbursement in over 25 markets and more than 2.5 million doses distributed globally.10
In October 2023, the U.S. Food and Drug Administration approved Vabysmo for the treatment of macular edema following RVO.6 Data up to 72 weeks from the BALATON and COMINO studies have been submitted to health authorities around the world, including the European Medicines Agency, for the treatment of macular edema following RVO.