New macular degeneration drug 'Vabysmo' now available

at Big 5 tertiary general hospitals

Vabysmo cleared the drug committee of major medical centers in South Korea

Since October, it has been listed for insurance reimbursement

Roche Korea’s Vabysmo (faricimab), the first bispecific antibody for ophthalmologic disease.

The macular degeneration drug 'Vabysmo' is now available for prescription at general hospitals.

 

According to industry sources, Roche Korea’s Vabysmo (faricimab), the first bispecific antibody for ophthalmologic disease, has passed the drug committee (DC) of Big 5 tertiary general hospitals, including Samsung Medical Center in Seoul, Seoul National University Hospital, Seoul Asan Hospital, and Severance Hospital.

 

It is also available for prescription at medical centers specializing in ophthalmologic disease, including Konyang University Hospital, Kim’s Eye Hospital, Nune Eye Hospital, Inje University Busan Paik Hospital, and Chung-Ang University Healthcare System.

 

Vabysmo is expanding its prescription areas after being listed for insurance reimbursement last October.

 

Approved in January 2023, it has been covered by reimbursement since last October to treat patients with neovascular or wet age-related macular degeneration (nAMD)-associated subfoveal choroidal neovascularization and to treat diabetic macular edema (DME).

 

Vabysmo is a new drug that targets both vascular endothelial growth factor (VEGF)-A and angiopoietin-2 (Ang-2), which are involved in major disease pathways.

 

Its clinical research for approval was based on a new mechanism.

 

As the first intravitreal injection administered every 4 months (16 weeks), it can alleviate the burden on patients with only a few doses of administration via injection.

 

The recommended dose for Vabysmo is 6 mg (0.05 mL) administered by intravitreal injection every month (4 weeks) for the first four administrations.

 

After the initial treatment, patients with Neovascular (Wet) Age-Related Macular Degeneration (nAMD) who do not show any disease activity receive injections once every 4 months (16 weeks).

 

Patients with DME can be dosed every 4 weeks for up to 4 months (16 weeks) with a doctor’s recommendation.

 

Meanwhile, Vabysmo demonstrated its efficacy through four Phase 3 clinical trials: TENAYA and LUCERNE for the treatment of neovascular age-related macular degeneration (nAMD), and YOSEMITE and RHINE for the treatment of diabetic macular edema (DME).

 

Among these trials, TENAYA and LUCERNE are non-inferiority trials comparing Vabysmo to 'Eylea (aflibercept)' for the treatment of Neovascular (Wet) Age-Related Macular Degeneration (nAMD).

 

The results demonstrated that Vabysmo treatment administered every 4 months (16 weeks) showed non-inferior vision improvements compared to Eylea treatment administered every 2 months (8 weeks) at 1 year of treatment.

 

In particular, 80% of the Vabysmo treatment group maintained an administration interval of over 3 months (12 weeks).

 

In 2-year studies, 60% of the patients maintained an administration interval of over 4 months (16 weeks).

 

The drug is expected to provide clinical benefits consistently.