Roche (SIX: RO, ROG; OTCQX: RHHBY) has disclosed compelling 72-week data derived from two global Phase III studies, BALATON and COMINO, evaluating Vabysmo® (faricimab) in the treatment of macular edema stemming from branch and central retinal vein occlusion (BRVO and CRVO). In contrast to existing retinal vein occlusion (RVO) treatments administered every one to two months, the data showcases a significant achievement, with almost 60% of individuals in BALATON and up to 48% in COMINO extending their treatment intervals to three or four months. Furthermore, participants in both studies sustained the vision gains and substantial retinal drying observed in the initial 24 weeks for over a year. The persistence of retinal drying is particularly crucial, as excessive fluid-induced swelling in the eye has been linked to vision distortions and blurriness.
Vabysmo demonstrated favorable tolerability in both studies, aligning with the safety profile established in prior research. Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development, remarked, “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.”
The long-term results further solidify Vabysmo’s efficacy as a viable treatment option for individuals grappling with retinal conditions that can lead to vision impairment. These pivotal findings will be virtually presented on February 3, 2024, at the Angiogenesis, Exudation, and Degeneration 2024 conference, hosted by the Bascom Palmer Eye Institute in Florida, United States.
Ramin Tadayoni, M.D., Ph.D., head of ophthalmology at the Cité University in Paris, France, and president of EURETINA, emphasized the significance of these sustained improvements, stating, “The sustained vision improvements and retinal drying seen up to 72 weeks reaffirm Vabysmo as an effective treatment for retinal vein occlusion.”
Both BALATON and COMINO studies assessed the average change in best-corrected visual acuity (BCVA) score and monitored the reduction in retinal fluid through central subfield thickness (CST). The results indicated that the vision enhancements and retinal fluid reductions achieved in the initial 24 weeks were consistently maintained up to 72 weeks.
For the BRVO (BALATON) study:
- Vision gains: Individuals receiving Vabysmo as a first-line treatment gained 18.1 letters on the eye chart at 72 weeks.
- Retinal drying: A reduction of 310.9 µm in retinal swelling was observed in those receiving Vabysmo as a first-line treatment.
For the CRVO (COMINO) study:
- Vision gains: Participants receiving Vabysmo as a first-line treatment gained 16.9 eye chart letters at 72 weeks.
- Retinal drying: A reduction of 465.9 µm in retinal swelling was noted in individuals receiving Vabysmo as a first-line treatment.
Vabysmo, the first and only bispecific antibody approved for the eye, has obtained approval in over 90 countries worldwide for neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME). In October 2023, the U.S. Food and Drug Administration sanctioned Vabysmo for treating macular edema following RVO, and data up to 72 weeks from BALATON and COMINO studies have been submitted to health authorities globally, including the European Medicines Agency, for the treatment of macular edema following RVO.