Eylea makes sole lead in the ₩100B nAMD Tx market

leads Korea’s macular degeneration treatment market... Beovu makes KRW 16.5 billion

Bayer’s Eylea makes new record with annual sales of KRW 80.4 billion last year

Novartis switches sales focus from Lucentis to Beovu... raises sales in the KRW 10 billion range

Lucentis’s sales fall for 2 consecutive years to reach KRW 29.4 billion...affected by price reduction and entry of its biosimilars

(from the left) Eylea, Lucentis, Beovu

The sole lead held by ‘Eylea’ in the domestic macular degeneration treatment market has been further solidified last year.

 

Also, Novartis has been aggressively promoting sales of its recently launched new drug ‘Beovu.' With Novartis focusing its sales strategy on Beovu, sales of the company’s lesser priority, 'Lucentis,’ further declined last year.

 

According to the market research institution IQVIA on the 11th, Korea’s macular degeneration treatment market grew by 14% YoY from KRW 111.1 billion the previous year and recorded KRW 126.3 billion last year..

 

Neovascular (Wet) Age-Related Macular Degeneration (nAMD) is considered one of the 3 major causes of blindness in the elderly aged 65 or older.

 

The risk increases as one grows older.

 

The growth of abnormal blood vessels (neovascular) results in the leakage of blood, lipid, or subretinal fluid, which damage the macula and lead to vision loss.

 

Excluding ‘Avastin,’ which is used off-label, three treatments are available for nAMD in Korea – Bayer’s ‘Eylea (aflibercept),’ Novartis’s ‘Lucentis (ranibizumab)' and ‘Beovu (brolucizumab).’ Lucentis was the first to be approved in 2007, followed by Eylea in 2013.

 

A decade later, Beovu was approved as a new drug.

 

Also, another new drug, Roche’s ‘Vabysmo,’ was approved in January this year.

 

Eylea made a new annual sales record of KRW 80.4 billion last year.

 

This is a 14% YoY increase from KRW 70.5 billion in 2021.

 

Eylea’s strength is that it allows patients to receive customized treatment by offering a broad dosing interval ranging from a minimum of 4 weeks to a maximum of 16 weeks.

 

The drug contributed to the establishment of the treat-and-extend (T&E) regimen in nAMD treatment, where the patients’ dosing interval is regulated after monitoring the patients during the initial 3 months of treatment.

 

Last year, the company introduced a pre-filled syringe formulation that reduces preparation time for drug administration by preparing the accurate dose for single administration in advance.

 

The new formulation improved the convenience of the treatment process.

 

However, sales of Lucentis, which was 2nd place in the market, have been decreasing for 2 consecutive years.

 

Lucentis’s annual sales decreased by 16% from the KRW 35.1 billion to record KRW 29.4 billion last year.

 

Lucentis’s sales have been decreasing continuously after peaking at KRW 37 billion in 2020.

 

The change occurred when Novartis, its seller, received approval for its new nAMD treatment Beovu.

 

Lucentis has been developed by Genentech and marketed by Roche and Novartis.

 

In Korea, Lucentis is being sold by Novartis.

 

Novartis developed its new drug and succeeded in receiving marketing approval for the drug in 2022.

 

The decrease in Lucentis’s sales had been an expected result with Novartis focusing its capabilities on the sales of Beovu.

 

Also, the entry of Lucentis’s biosimilars into the market upon Lucentis’s patent expiry heated up the competition this year.

 

Chong Kun Dang and Samsung Bioepis started selling their Lucentis Biosimilars, ‘LucenBS,' and ‘Amelivu inj’ in January this year.

 

With both drugs listed for reimbursement, Lucentis’s drug price had been reduced by 30% ex officio from February this year.

 

Lucentis’s position as the original drug in the market is expected to weaken further as the companies that own Lucentis biosimilars have been competitively lowering drug prices to gain an advantage earlier in the market.

 

Meanwhile, Novartis’s new drug Beovu’s sales exceeded KRW 10 billion last year.

 

Last year, Beovu’s sales increased 205% YoY from the KRW 5.4 billion in the previous year to record KRW 16.5 billion.

 

Unlike other existing treatments that have dosing intervals of 4-8 weeks, Beovu has a dosing interval of up to 12 weeks (3 months).

 

This was evaluated to have improved patient compliance by reducing the difficulties of patients that had to receive injections into the eye.

 

The low compliance in patients with nAMD had been pointed to as a major issue that reduces the actual treatment effect of the nAMD treatments.

 

Beovu demonstrated its non-inferiority with Eylea with its 12-week administration through a head-to-head trial.

 

The therapeutic effect lasted until week 96.

 

Also, the Beovu-treated group showed superior improvement in intra-retinal fluid and sub-retinal fluid compared to the Eylea-treated group The reason Beovu produces a similar effect despite the longer dosing interval is due to its molecular characteristics.

 

Beovu’s single-chain antibody fragment (ScFv) is engineered to deliver a higher concentration of molecules compared to other treatments with multiple chains.

 

However, HCPs have been showing divided opinions on its use due to its side effect of retinal vasculitis, which is unseen in other existing treatments.

 

In particular, the introduction of Vabysmo, the first bispecific antibody introduced to the field of ophthalmic diseases, is expected to somewhat dilute Beovu’s strengths of 'high efficacy and convenience.’ Vabysmo is the first bispecific antibody that targets both the VEGF which is commonly targeted by existing ocular disease treatments as well as Ang-2 that is considered to be the cause of retinal disease to block both pathways.

 

In particular, it has improved convenience in administration over other existing treatments with a dosing interval of up to 16 weeks (4 months).

 

If listed for reimbursement, Vabysmo is expected to start a full-fledged competition with Beovu.