NETHERLANDS – A committee of the European Medicines Agency (EMA) has recommended the approval of Roche’s Vabysmo to treat neovascular or wet age-related macular degeneration (AMD) and diabetic macular edema (DME).

The panel backing means that the drug is on course to be fully approved and ready to roll out in the next few months, subject to pricing and reimbursement negotiations.

Roche’s new eye disease drug Vabysmo has been competing with Regeneron and Bayer’s mighty Eylea in the US – and is set to lock horns with its rival in Europe.

Vabysmo is a bispecific antibody that acts by binding to VEGF – the same target as US$8 billion-a-year blockbuster Eylea (aflibercept) – as well as a second target Ang-2, tackling two disease pathways associated with the sight-robbing diseases.

Vabysmo was only approved in the US in January but already seems to have made great headway in the market, with Roche reporting second quarter sales of around US$112 million and more than 70,000 vials distributed in the first five months since its debut.

Worryingly for Bayer and Regeneron, the pharma group says Vabysmo’s strong uptake is being driven in part by switching “primarily from aflibercept” as it chases market share in a global retinal diseases market valued at around US$15 billion.

The panel backing means that the drug is on course to be fully approved and ready to roll out in the next few months, subject to pricing and reimbursement negotiations.

Vabysmo still has a mountain to climb to catch Eylea, but Roche continues to build the clinical case for its drug reporting two-year results with the drug in wet AMD earlier this month which suggested it continued to be effective whilst cutting the number of injections into the eye needed by patients.

Over the two-year period, patients received 10 injections with the bispecific antibody, compared to 15 with Regeneron and Byer’s drug.

Last year, Bayer and Regeneron rang up sales of US$8.7 billion for Eylea, ranking the blockbuster among the world’s top 10 best-selling drugs for the fifth straight year.

But Vabysmo presents a threat primarily because of its dosing regimen. After a series of four monthly injections, patients can go between one to four months between maintenance injections, depending on their outcomes and anatomy. For Eylea, the regimen is every two months.

Nonetheless, Regeneron is working on a higher-dose version of Eylea that could be given every four months. But the best case for approval is the second half of 2023.

This isn’t Roche’s first run at the macular degeneration market. Its aging drug Lucentis made US$1.5 billion in 2021.

But it faces generic competition this year from Samsung Bioepis’ Byooviz, the first biosimilar approved by the FDA for use in the eye.

Roche also has a surgical implant system Susvimo, which was approved late last year by the FDA and requires even fewer doctor visits than Vabysmo. But reception and uptake so far has been lukewarm.

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