Roche's Vabysmo Demonstrates Sustained Efficacy in Retinal Vein Occlusion with Extended Dosing Intervals
核心洞察
New 72-week data from Phase III BALATON and COMINO studies show Vabysmo maintained vision gains and robust retinal drying for over one year in patients with branch and central retinal vein occlusion (搜索).
Nearly 60% of BALATON patients and up to 48% of COMINO patients achieved extended treatment intervals of three to four months, compared to typical monthly or bi-monthly dosing with current therapies.
This represents the first time vision and anatomical improvements have been sustained for more than one year in global Phase III studies for both types of retinal vein occlusion (搜索).
Roche announced compelling 72-week results from two pivotal Phase III studies demonstrating that Vabysmo (faricimab) maintains sustained vision improvements and retinal fluid reduction in patients with retinal vein occlusion (搜索) (RVO) while allowing for significantly extended dosing intervals. The BALATON and COMINO studies represent the first global Phase III trials to show maintained vision and anatomical benefits for over one year in both branch and central retinal vein occlusion (搜索).
Extended Dosing Intervals Reduce Treatment Burden
The studies revealed that nearly 60% of patients with branch retinal vein occlusion (搜索) (BRVO) in BALATON and up to 48% of patients with central retinal vein occlusion (搜索) (CRVO) in COMINO were able to extend their treatment intervals to three or four months apart. This represents a significant advancement over current RVO treatments, which typically require injections every one to two months.
"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 (搜索)," 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."
Sustained Vision and Anatomical Improvements
BRVO Results (BALATON Study)
At 72 weeks, patients receiving Vabysmo as first-line treatment achieved substantial vision gains of 18.1 letters on the eye chart, while those switched from aflibercept to Vabysmo gained 18.8 letters. These improvements were maintained from the initial 24-week results, which showed vision gains of +16.8 letters for Vabysmo and +17.5 letters for aflibercept.
Retinal drying, measured by central subfield thickness (CST) reduction, remained robust at 72 weeks. First-line Vabysmo patients experienced a 310.9 μm reduction in retinal swelling, while those switched from aflibercept saw a 307 μm reduction. These results closely matched the 24-week outcomes of 314.5 μm and 307.6 μm reductions respectively.
CRVO Results (COMINO Study)
In central retinal vein occlusion (搜索), patients receiving first-line Vabysmo treatment gained 16.9 eye chart letters at 72 weeks, with switched patients achieving 17.1 letters. The initial 24-week results showed comparable gains of +16.9 letters for Vabysmo and +17.3 letters for aflibercept.
Retinal fluid reduction was particularly pronounced in CRVO patients, with first-line Vabysmo treatment resulting in a 465.9 μm CST reduction at 72 weeks, compared to 460.6 μm in switched patients. These sustained improvements built upon the strong 24-week results of 462.3 μm and 447.8 μm reductions respectively.
Clinical Significance and Mechanism of Action
Retinal drying represents a crucial clinical measure, as swelling from excess fluid in the back of the eye has been associated with distorted and blurred vision. The sustained reduction in retinal fluid across both studies demonstrates Vabysmo's continued therapeutic benefit over extended treatment periods.
Vabysmo's unique mechanism as the first and only bispecific antibody approved for the eye enables it to target and inhibit two signaling pathways linked to vision-threatening retinal conditions. By neutralizing both angiopoietin-2 (搜索) (Ang-2) and vascular endothelial growth factor-A (搜索) (VEGF-A (搜索)), Vabysmo works to restore vascular stability. The elevated levels of Ang-2 in RVO are thought to drive disease progression alongside VEGF factors.
Study Design and Safety Profile
Both BALATON (553 BRVO patients) and COMINO (729 CRVO patients) were randomized, multicentre, double-masked global Phase III studies. For the first 20 weeks, participants received monthly injections of either Vabysmo (6.0 mg) or aflibercept (2.0 mg). From weeks 24 to 72, all individuals received Vabysmo using a treat-and-extend dosing regimen up to every four months.
Across both studies, Vabysmo was well tolerated with a safety profile consistent with previous clinical trials. No new safety signals were identified during the extended treatment period.
Global Impact and Market Access
RVO affects an estimated 28 million adults globally, primarily those aged 60 or older, and represents the second most common cause of vision loss due to retinal vascular conditions. The condition can lead to severe and sudden vision loss, with branch retinal vein occlusion (搜索) affecting more than 23 million people globally and central retinal vein occlusion (搜索) affecting more than four million people worldwide.
Vabysmo is currently approved in more than 90 countries for neovascular age-related macular degeneration (搜索) and diabetic macular edema (搜索), with public reimbursement in over 25 markets and more than 2.5 million doses distributed globally. In October 2023, the U.S. Food and Drug Administration approved Vabysmo for RVO treatment, with submissions to other health authorities worldwide ongoing.
"The sustained vision improvements and retinal drying seen up to 72 weeks reaffirm Vabysmo as an effective treatment for retinal vein occlusion (搜索)," said Ramin Tadayoni, M.D., Ph.D., head of ophthalmology at the Cité University in Paris, France, and president of EURETINA. "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."