Beovu heats up the AMD treatment market with its ease of use

As Novartis's successor to Lucentis, reduced the required no. of doses to improve patient compliance

Demonstrated non-inferiority to Eylea with better anatomical improvement

Novartis has jumped into the competition in the macular degeneration treatment market with ‘Beovu.’ Emphasizing its longer treatment interval, the new drug is fiercely chasing the market leader ‘Eylea.’ Beovu (brolucizumab) is a treatment for wet (neovascular) age-related macular degeneration (AMD) launched by Novartis as a successor to its ophthalmology drug ‘Lucentis.’ The prefilled syringe formulation of Beovu was approved in Korea last July and is being reimbursed from this month.

 

The biggest benefit of Beovu is its longer treatment interval.

 

Beovu is administered once every 4 weeks for the first three doses, followed by once every 12 weeks.

 

Bayer’s Eylea is also administered monthly like Beovu for the first 3 doses, however, the following doses for Eylea are administered every 8 weeks.

 

In other words, patients who had to visit the hospital every 2 months will be able to increase the interval to every 3 months with Beovu, which may improve convenience and the possibility of patient compliance.

 

At the Beovu press conference held by Novartis Korea on the 5th, Sang-jin Kim, a professor of ophthalmology at Samsung Medical Center, said, “ In macular degeneration, the number of injections administered is highly correlated to vision maintenance.

 

However, many AMD patients fail to continue treatment due to that burden of treatment, which results in reduced vision improvement effects.

 

Therefore, the unmet need that existed for a treatment that can maintain its efficacy while reducing the number of injections and hospital visits may be satisfied with the introduction of Beovu." Beovu demonstrated its non-inferiority in head-to-head clinical trials with Eylea.

 

In the Beovu HAWK and HARRIER clinical trials conducted by Novartis, the Beovu-treated group showed non-inferiority in the best-corrected visual activity (BCVA), the primary endpoint, compared to the Eylea-treated group at week 48.

 

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.

 

With the higher molar concentration, the agent potently inhibits vascular endothelial growth factor A (VEGF-A) isoforms, has better tissue penetration, and clears more rapidly from systemic circulation.

 

However, why vision gains with Beovu at week 96 is similar to that of Eylea even with stronger effects may be yet questionable.

 

“Opinions have been divided among doctors on the reason behind the matter.

 

Personally, I would say that anatomical changes such as exudates often precede functional changes.

 

However, it is true that in the long-term, the possibility of degeneration happening in photoreceptor cells, etc.

 

is high as the period exudate remains is prolonged.” Kim added, “Although there was no difference in vision gains during the 96-week study period, I believe there will be a difference in the long-term.” Also, another hidden competitor to note is the anticancer drug ‘Avastin,.' Since Avastin has the same mechanism as Lucentis but is relatively cheaper than Lucentis or Eylea, off-label prescription of Avastin for the treatment of AMD is known to be quite active in the treatment of macular degeneration.

 

The price of the newly reimbursed Beovu is similar to that of Eylea, and this higher price compared to Avastin is an obstacle.

 

On this, the company stated that "Beovu was approved for the same indication as with other macular degeneration treatments, so we do not foresee big changes in the current market.

 

We would have to wait and see in the long run as patients who have a lot of remaining exudate, or those who wish to reduce more exudate may choose Beovu over other competitors.” According to data from IQIVA, Eylea made 63.6 billion won, and Lucentis 36.9 billion won in sales last year.