'Vabysmo’s 4mth dosing interval may reduce patient burden'

Roche Korea holds press conference to celebrate Vabysmo’s approval in Korea

First bispecific antibody in ophthalmology...only drug that inhibits the disease factor angiopoietin-2

“Patients experience high burden due to every 4-8 week administration...Vabysmo will offer an alternative for these patients”

A new drug for Neovascular (Wet) Age-Related Macular Degeneration (nAMD) that offers treatment effect with once every 4-month administration has landed in Korea.

 

The new option is expected to greatly improve the convenience of administration in domestic patients whose number has been increasing with Korea’s aging population.

 

Roche Korea held a press conference on the 7th to celebrate the approval of Vabysmo (faricimab) at its headquarters in Seocho-gu, Seoul.

 

Vabysmo is the first bispecific antibody that targets both the VEGF that is commonly targeted by existing ocular disease treatments as well as angiopoietin-2 (Ang-2) that are considered to be the cause of retinal disease to block both pathways.

 

MOA of Vabysmo

Vabysmo has demonstrated non-inferiority over Eylea in improving vision outcomes in a Phase III study and was approved in Korea in January as a treatment for the treatment of patients with Neovascular (Wet) Age-Related Macular Degeneration (nAMD) and Diabetic Macular Edema (DME).

 

With the approval, the total number of AMD treatments available in Korea increased to 4 – Vabysmo (Roche), Eylea (Bayer), Lucentis (Novartis), and Beovu (Novartis).

 

nAMD is considered one of the 3 major causes of blindness in the elderly aged 65 or older.

 

The importance of its treatment is increasing with the rising number of patients in the rapidly aging society.

 

During his presentation, ophthalmologist Kim Jae-hui, (Kim’s Eye Hospital) said, “The widely used nAMD treatments Eylea and Lucentis are effective but have their limitations.

 

One is that the drugs have to be injected frequently for a longer period of time to maintain the patients' vision and anatomical improvements.

 

Also, the response may be limited even with treatment depending on the patient.

 

In this sense, expectations are rising on treatment effect as the only drug that also inhibits Ang-2.

 

“

Ophthalmologist Jae-Hui Kim (Kim

The bispecific antibody Vabysmo has demonstrated that it can produce comparable effects to existing treatments while significantly increasing the dosing interval.

 

After the first 4 doses are administered by intravenous injection every 4 weeks, the dosing interval for patients with no disease activity can be extended to every 16 weeks (4 months).

 

In other words, the effect that existing treatments offered with every 1-2 month administration can be achieved with up to every 4-month administration of Vabysmo.

 

In two Phase III trials conducted on 1,329 patients, patients who received Vabysmo at dosing intervals of up to 4 months showed non-inferiority over its comparator, the 2-month interval treatment Eylea, in improving vision outcomes after 1 year of treatment.

 

Over half of the Vabysmo-administred patients were maintaining the 4-month dosing interval after 1 year of treatment.

 

Kim expected that the introduction of Vabysmo and its longer dosing interval would benefit patients who had felt burdened by the frequent injections to the eye.

 

Kim said, “In many cases, it was difficult to reproduce the results that were found in the clinical setting on-site because patients cannot receive regular injections in the long term as strictly as they would have had in clinical trials.

 

So, their effect was reduced in line with the reduced number of injections the patients received.

 

In this sense, I have higher hopes for Vabysmo as it only needs to be injected once every four months, which reduces patient burden.

 

During practice, I often encountered patients whose edema does not go away with existing treatments, but data has shown that Vabysmo can remove edema at a higher rate.

 

I think this will benefit the patients who have had shown limited response to existing treatments” At the press conference, Roche Korea expressed the company's plans to promptly supply Vabysmo in Korea through quick reimbursement listing.

 

In-Hwa Choi, Lead at Roche Korea, said, “Vabysmo has been approved in 50 countries worldwide and is reimbursed in A7 countries and Australia.

 

We have already applied for its reimbursement at the end of last year before it was approved in Korea.”