Roche gets FDA approval for prefilled Vabysmo syringe

Roche's Vabysmo has received FDA approval to be distributed in a prefilled syringe, offering a more convenient option for retina specialists who administer this blockbuster drug. Launched in 2022, Vabysmo has quickly gained traction in a market long dominated by Regeneron and Bayer’s Eylea.

On Friday, Roche announced that the FDA has given the green light for Vabysmo to be available in a prefilled, 6-mg, single-dose syringe. This new format simplifies the administration process for doctors, as they no longer need to extract the medication from a vial. The prefilled syringe will be available later this year, in addition to the current vial form, for treating three specific eye conditions. The FDA initially approved Vabysmo for wet-age macular degeneration and diabetic macular edema in January 2022, followed by approval for retinal vein occlusion nine months ago.

Dr. Levi Garraway, Roche's chief medical officer and head of global product development for its subsidiary Genentech, stated that while many retina specialists already use Vabysmo as a first-line treatment, the prefilled syringe will simplify the administration process and improve the treatment experience for both physicians and patients.

The prefilled syringe offers various benefits, including reducing the risk of contamination and dosing errors. Additionally, the overall process of storing and disposing of the medication is more straightforward as it requires fewer materials.

In the United States, nearly 3 million individuals suffer from one of the three eye diseases that Vabysmo targets, each with the potential to cause blindness. Roche reports that over 4 million doses of Vabysmo have been distributed worldwide across the 95 countries where the drug has been approved.

Vabysmo entered the market as the sole bispecific antibody treatment for the eye, with a significant advantage in its dosing regimen. It can extend dosing intervals up to four months, whereas Eylea requires more frequent dosing every two months. In response, Regeneron and Bayer received FDA approval in August last year for their high-dose Eylea, which can extend dosing intervals beyond four months for some patients.

Financially, Vabysmo has shown impressive growth. In the first quarter of 2024, it generated sales of 847 million Swiss francs ($933 million), marking a 108% increase compared to the previous year. Conversely, Regeneron reported a 2% drop in sales for its Eylea franchise in the U.S., totaling $1.4 billion, with Eylea HD contributing $200 million.

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