Waldemarus
- Roche (OTCQX:RHHBY) unit Genentech announced Friday that the U.S. Food and Drug Administration (FDA) approved a new ready-to-use format for its eye disease therapy Vabysmo to treat three leading causes of vision loss.
- Accordingly, the bispecific antibody, also known as faricimab, will be available in a new format for neovascular or ‘wet’ age-related macular degeneration (nAMD), diabetic macular edema, and macular edema following retinal vein occlusion.
- The three retinal diseases affect an estimated 80M people worldwide. The new formulation delivers the same medication in an alternative, ready-to-use format as part of a 6.0 mg single-dose prefilled syringe (PFS).
- The company said Vabysmo, which cleared the initial U.S. regulatory hurdles in 2022, will also continue to be available in a 6.0 mg vial. The Swiss drugmaker expects to launch the product in the coming months.