Vabysmo’s real-world data to hold leader Eylea in check

Announces real-world data results... many patients switched from Eylea to Vabysmo

Confirmed improvement in central subfield thickness and visual acuity after switching to Vabysmo

Whether Vabysmo is listed this year will serve as a variable in the market with the delayed introduction of high-dose Eylea

The competition between the current lead ‘Eylea’ and the new drug ‘Vabysmo’ is fierce in the macular degeneration treatment market.

 

Based on the real-world data that demonstrated Vabysmo’s consistent effect on patients who switched from Eylea, the company built evidence for patients to switch to Vabysmo.

 

To defend the lead, Eylea’s company has attempted to release a high-dose version of Eylea but has been experiencing difficulties due to its delayed introduction.

 

According to industry sources on the 5th, the global real-world data on Vabysmo was recently published in the international journal ‘Nature.’ The results of the investigator-led trial that was published are the first real-world data that provides a glimpse of what kind of effect Vabysmo can bring to the field..

 

Roche’s bispecific antibody Vabysmo (faricimab) is a new drug approved in Korea for the treatment of macular degeneration.

 

The current leader in this market is Bayer and Regeneron’s ‘Eylea (aflibercept).’ One thing to note was that a significant proportion of the patients included in the real-world study were those that had been previously treated with ‘Eylea.’ 337 of the 376 eyes of 335 patients that participated in the study had been previously treated with an anti-VEGF agent, 237 eyes of which were treated with Eylea.

 

Patients in the study switched to Vabysmo due to non-response or to extend their treatment cycle after using Eyelea.

 

The other 39 eyes were treatment-naive eyes.

 

The primary endpoints of the study were the changes in best-corrected visual acuity (BCVA), changes in central subfield thickness (CST), and safety, and the Secondary outcome measures included treatment intervals and the presence of retinal fluid.

 

Results showed that after a single injection of Vabysmo, the mean CST reduction in previously-treated eyes was -25.3μM, and this mean value became -26.3μm in patients who were previously treated with Eyela.

 

All patients treated with Vabysmo, including those with treatment-naïve eyes, demonstrated a mean reduction in CST of -31.3μm.

 

Also, a number of patients demonstrated complete resolution of intraretinal fluid (IRF), subretinal fluid (SRF), or pigment epithelial detachment (PED).

 

Patients demonstrated further improvement after 3 injections of Vabysmo.

 

In the 337 eyes that switched to Vabysmo, the mean BCVA increase from baseline was +2.7, and the mean CST reduction of -38.1μm.

 

Patients that switched from Eylea to Vabysmo demonstrated a mean BCVA increase of +2.2 letters, and a mean CST reduction of −42.6μ from baseline.

 

The anatomical outcomes in the study showed that Vabysmo improved 17.8% resolution of IRF, 36.6% resolution of SRF, and 11.1% resolution of PED in patients that switched from another drug.

 

Patients that switched from Eylea showed a 12.3%, 37.2%, and 3.2% resolution of IRF, SRT, and PED, respectively.

 

The reduction or removal of retinal fluid from the use of Vabysmo is analyzed to have affected the maintenance and improvement of visual acuity.

 

Two cases of intraocular inflammations were reported in the 376 eyes treated in the study, and their vision returned to baseline after treatment.

 

◆ Eylea faces difficulties with Vabysmo chasing at its tail Based on the real-world results, Roche is expected to speed up targeting Eylea’s share.

 

Currently, Eylea has an overwhelming lead in the domestic macular degeneration treatment market.

 

According to the market research institution IQVIA, Eylea recorded annual sales of KRW 80.4 billion last year.

 

This is a 14% increase from 2021.

 

Eylea accounted for 64% of the total macular degeneration treatment market (KRW 126.3 billion).

 

Therefore, all the new drugs released to the market are targeting Eylea’s share, attempting to take a piece of the pie before Eylea’s patent expiry and the entry of its biosimilars.

 

In Korea, Vabysmo entered the market this year, following ‘Beovu’ in 2020.

 

In just 2 years of its release, Beovu posted KRW 16.5 billion in sales last year.

 

In particular, the new entrant Vabysmo has been considered a strong contestant against Eylea because after administering the initial 4 doses at 4-week intervals, and then, Vabysmo can be administered every 16 weeks (4 months) if there is no disease activity.

 

Many patients with macular degeneration often give up treatment due to the fear of receiving an injection in the eye, therefore extending the dosing interval was considered an important task in treatment development.

 

And the new contestant improved the convenience of patients with a 16-week dosing interval.

 

Eylea’s dosing interval can be extended up to 16 weeks if the patient’s disease is well managed, but the drug is administered every 4 weeks for the first 3 months and then every 8 weeks.

 

However, Eylea has the advantage of being able to flexibly take the treatment interval depending on the patient's condition, from 4 weeks to 16 weeks.

 

In the global market where Eylea and Vabysmo had already taken place, Vabysmo has been rapidly increasing its market share.

 

According to Roche's earnings report, Vabysmo’s global sales in Q1 this year were CHF 432 million (approximately KRW 620 billion).

 

When considering how the drug was approved in the US and Europe in January and September last year, respectively, the drug has shown high growth.

 

On the other hand, Eylea experienced a drop in sales for two consecutive quarters from Q4 last year.

 

Bayer and Regeneron had set out to introduce a high-dose 8mg version of Eylea to defend the market.

 

However, the companies are facing difficulties as the US FDA declined approval of the higher-dose version.

 

According to Regeneron, the approval was deferred due to a delay in the review of a drug’s third-party manufacturer and is not because of any efficacy or safety issues related to the drug.

 

As long as there is no problem with the drug, there is no possibility that the FDA will completely turndown its approval.

 

However, the FDA's decision delays the release of the high-dose version and is expected to delay Eylea’s defense strategy.

 

In Korea, the environment is still favorable for Eylea because Vabysmo has not been listed for reimbursement yet.

 

Therefore, Eylea’s sales this year will be affected by the timing of Vabysmo’s reimbursement listing.

 

Also, the growth of Beovu, which is being more actively used in Korea than in the global market, should be watched closely.