'Vabysmo' for macular deg associated RVO indication expected

The MFDS is conducting the final review round

Competition has been expanded for treatements like Eyelea·Lucentis

Product photo of Vabysmo.

The first bispecific antibody for eye diseases, 'Vabysmo,' is soon to be approved in South Korea for its indication of treating macular degeneration associated retinal vein occlusion (RVO).

 

According to industry sources, Roche Korea's Vabysmo (faricimab) is being reviewed by the Ministry of Food and Drug Safety (MFDS) for its indication expansion.

 

It is expected to be approved within the year.

 

For RVO indication, it received the U.S.

 

FDA approval in October 2023.

 

Attention has been drawn to Vabysmo, a treatment for macular degeneration because it significantly extended the administration interval compared to Bayer's 'Eylea (aflibercept), which has been the standard therapy.

 

In South Korea, Vabysmo's prescription became available after it was approved for reimbursement listing for neovascular age-related macular degeneration (nAMD) and diabetes-related macular edema (DME) in October last year.

 

Existing macular degeneration drugs used in South Korea are vascular endothelial growth factor-A (VEGF-A) drugs such as Novartis' 'Lucentis (ranibizumab),' 'Beovu (brolucizumab),' and Eylea.

 

Unlike existing VEGF drugs, like Lucentis and Eylea, Vabysmo can also block the angiopoietin-2 (Ang-2) pathway, thus inhibiting new blood vessel formation.

 

The analysis suggests that blocking two independent pathways can more effectively stabilize blood vessels and reduce inflammation, abnormal vessel growth, and fluid leakage than the VEGF-A pathway alone.

 

RVO is Vabysmo's third indication.

 

Its efficacy has been confirmed through the Phase 3 BALATON and COMOINO studies.

 

In these two clinical trials, Vabysmo achieved non-inferiority in the patient's vision improvement compared to Eylea.

 

When treated with Eylea, the patients had continual vision improvements from the early stage.

 

The safety profile of the trials was similar to previous study reports.

 

Meanwhile, Vabysmo has seen an increase in sales this year.

 

Its sales for Q1 amounted to 847 million francs, up 88.6% from the previous year.

 

It recorded sales of 947 million francs (about 1.51 trillion won) in Q2, up 86.4% from last year.

 

In Q2, Vabysmo surpassed the sales of the market leader Eylea (about 1.26 trillion won) for the first time.