Vabysmo PFS is the first and only prefilled syringe containing a bispecific antibody, offering a convenient alternative to currently available Vabysmo vials
Vabysmo has demonstrated rapid and robust vision and anatomical improvements in neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME) and retinal vein occlusion (RVO)
The ready-to-use Vabysmo PFS is co-packaged with the only CE-marked needle specifically designed for intravitreal injection
Basel, 13 December 2024– Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Medicines Agency has approved Vabysmo® (faricimab) 6.0 mg single-dose prefilled syringe (PFS) for use in the treatment of neovascular or ‘wet’ age-related macular degeneration (nAMD), diabetic macular edema (DME) and macular edema following retinal vein occlusion (RVO). Together, these three conditions affect more than nine million people in the European Union (EU) and can have a devastating impact – physically, emotionally, and economically – on those affected, their families and caregivers.1-5
“Approval of the Vabysmo prefilled syringe in the EU offers a convenient way for ophthalmologists to administer this treatment for people with three of the most common causes of vision loss,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “This simplified administration may thereby help reduce the treatment burden for patients and retina specialists.”
The Vabysmo PFS provides ophthalmologists with the first and only CE-labelled needle for intravitreal injection. Vabysmo PFS delivers the same medicine as the currently available 6.0 mg Vabysmo vials in an alternative, ready-to-use format.6 More than five million doses of Vabysmo have been distributed globally since its initial US approval in 2022.6-11 Vabysmo PFS was first approved for nAMD, DME and RVO by the United States Food and Drug Administration in July 2024.7 Vabysmo PFS will be the European Union’s first and only prefilled syringe containing a bispecific antibody to treat retinal conditions that can cause blindness.
About Vabysmo® (faricimab)
Vabysmo is the first bispecific antibody approved for the eye.7,8,12 It targets and inhibits two signalling pathways linked to a number of vision-threatening retinal conditions by neutralising angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A). Ang-2 and VEGF-A contribute to vision loss by destabilising blood vessels, causing new leaky blood vessels to form and increasing inflammation. By blocking pathways involving Ang-2 and VEGF-A, Vabysmo is designed to stabilise blood vessels.12,13 Vabysmo is approved in more than 100 countries around the world, including the United States (US), Japan, the United Kingdom and the European Union (EU) for people with neovascular or ‘wet’ age-related macular degeneration and diabetic macular edema, and in more than 30 countries, including the US, EU and Japan, for people with macular edema following retinal vein occlusion. Review by other health authorities is ongoing.
About Roche in Ophthalmology
Roche is focused on saving people’s eyesight from the leading causes of vision loss through pioneering therapies. Through our innovation in the scientific discovery of new potential drug targets, personalised healthcare, molecular engineering, biomarkers and continuous drug delivery, we strive to design the right therapies for the right patients.
We have the broadest retina pipeline in ophthalmology, which is led by science and informed by insights from people with eye diseases. Our pipeline includes innovative treatments across different modalities, such as antibodies, and gene and cell therapies targeting multiple vision-threatening conditions, including retinal vascular and diabetic eye diseases, geographic atrophy, and autoimmune conditions, such as thyroid eye disease and uveitic macular edema.
Applying our extensive experience, we have already brought breakthrough ophthalmic treatments to people living with vision loss. Susvimo® (previously called Port Delivery System with ranibizumab) 100 mg/mL for intravitreal use via ocular implant is the first United States Food and Drug Administration-approved refillable eye implant for neovascular or ‘wet’ age-related macular degeneration that continuously delivers a customised formulation of ranibizumab over a period of months.14,15 Vabysmo® (faricimab) is the first bispecific antibody approved for the eye, which targets and inhibits two signalling pathways linked to a number of vision-threatening retinal conditions by neutralising angiopoietin-2 and vascular endothelial growth factor-A.7,8,12,13 Vabysmo is approved around the world for people living with nAMD, diabetic macular edema and macular edema following retinal vein occlusion.6-11 Lucentis® (ranibizumab injection)* was the first treatment approved to improve vision in people with certain retinal conditions
About Roche
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.
Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.
Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the twelfth consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).
The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2020 employed more than 100,000 people worldwide. In 2020, Roche invested CHF 12.2 billion in R&D and posted sales of CHF 58.3 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan