FDA Approves Vabysmo as Prefilled Syringe

The FDA has approved Genentech’s Vabysmo (faricimab-svoa) as a 6.0 mg single-dose prefilled syringe (PFS) to treat patients with wet, or neovascular, age-related macular degeneration (AMD), diabetic macular edema (DME) and macular edema following retinal vein occlusion (RVO). Together, these three conditions affect close to 3 million people in the United States.

The prefilled syringe of Vabysmo will become available in the coming months, according to a news release.

Vabysmo is also available as an injection for the same indications and the injection form has a list price of $2,190 per treatment. Genentech offers a $0 copay program for commercially insured patients, with a limit of $15,000 a calendar year.

Terms indicate the assistance is to be used to reduce the out-of-pocket costs for the patient and “are not intended for the benefit of third parties, including without limitation third party payers, pharmacy benefit managers, or their agents.” The terms of the program said that if the assistance “is excluded from counting towards the patient’s deductible or out-of-pocket cost limitations, Genentech may impose a per fill cap on the cost-sharing assistance available.”

Related: Three Cases of Severe Eye Inflammation Occur After Vabysmo Injection, Report Johns Hopkins Retina Specialists

Vabysmo is a bispecific antibody that targets and inhibits two disease pathways involved in retinal conditions: neutralizing angiopoietin-2 (Ang-2) and VEGF factor-A (VEGF-A). Both Ang-2 and VEGF-A are thought to contribute to vision loss by destabilizing blood vessels, which may cause new leaky blood vessels to form and increase inflammation.

Genentech is a division of Roche, and Vabysmo is one of Roche’s best-selling drugs. Approved in January 2022, Vabysmo achieved 2023 worldwide sales of 2.36 billion Swiss francs (about $2.64 billion), which is an increase of 324% over 2022, according to the 2023 earnings from Roche. In the United States alone, Vabysmo generated sales of 1.91 billion Swiss francs ($2.13 billion), an increase of 293% from 2022.