Roche Receives FDA Approval for Vabysmo (Faricimab) Prefilled Syringe for Retinal Diseases

Jul 05, 2024 20:00 CST Updated 20:00

Roche

Oncology Drug Research, Development, and Manufacturing

On July 5, Roche announced that the FDA had approved Vabysmo (faricimab) 6.0mg single-dose prefilled syringe (PFS) for the treatment of wet age-related macular degeneration (wAMD), diabetic macular edema (DME), and macular edema secondary to retinal vein occlusion (RVO).

Faricimab is a bispecific monoclonal antibody developed by Roche that targets angiopoietin-2 (Ang2) and vascular endothelial growth factor A (VEGFA). It is also the first bispecific antibody drug in the ophthalmology field. In January 2022, Faricimab (vial version) was approved for the first time in the United States for the treatment of DME and wAMD. In October 2023, Faricimab (vial version) expanded its indications to include macular edema secondary to RVO. In December of the same year, the product was approved for marketing in China under the trade nameRoche.

Left: Vial version; Right: Prefilled syringe version

Since its approval and market launch in 2022, Vabysmo has been sold over 4 million doses globally. According to Roche's 2023 annual report,Vabysmo Global Sales Reach 2.357 Billion Swiss Francs (Approximately 2.634 Billion USD).

The previously approved vial version required the use of a syringe to transfer the medication from the vial to the syringe before injecting it into the patient's eye. This packaging version is slightly less convenient, with possible occurrences of liquid residue and potential secondary injection contamination during use. The pre-filled syringe version approved this time has the medication pre-stored in the syringe.Improved the product'sConvenience of use, reducedResidual liquid,And can reduceThe Risk of Secondary Injection Contamination.

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