Roche has received approval from the US Food and Drug Administration (FDA) for the Vabysmo (faricimab) 6.0mg single-dose prefilled syringe (PFS) to treat three leading causes of vision loss.
The single-dose Vabysmo PFS is indicated for neovascular ("wet") age-related macular degeneration (nAMD), macular oedema following retinal vein occlusion (RVO) and diabetic macular edema (DME).
The newly approved Vabysmo PFS will be available to US retina specialists and their patients later in 2024.
The PFS provides an alternative, ready-to-use dosing option for the same medication as existing Vabysmo vials.
Roche will continue to supply Vabysmo in the 6mg vial format alongside the PFS.
A bispecific antibody for ocular use, Vabysmo demonstrated swift and substantial improvements in vision and retinal drying for patients with nAMD, DME and RVO.
Approved in more than 95 countries for nAMD and DME, Vabysmo also has approvals in the US and Japan for RVO.
Since its initial US approval in 2022, more than four million doses have been distributed worldwide.
The bispecific antibody targets both angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A pathways that contribute to vision loss by destabilising blood vessels and promoting the formation of leaky vessels and inflammation.
By inhibiting these pathways, Vabysmo stabilises blood vessels and preserves vision.
Roche Global Product Development head and chief medical officer Levi Garraway stated: “We are pleased that the US FDA has approved the Vabysmo PFS for people living with neovascular age-related macular degeneration, diabetic macular oedema and retinal vein occlusion, which are some of the leading causes of vision loss.
“While many retina specialists are already using Vabysmo as a first-line treatment, this new offering should make it even simpler to administer, thereby enhancing the treatment experience for both physicians and patients.”
The latest development comes after the Committee for Medicinal Products for Human Use of the European Medicines Agency recommended granting approval for Roche’s PiaSky (crovalimab) to treat paroxysmal nocturnal haemoglobinuria.
