EU Approves Roche's Vabysmo PFS for Three Vision-Threatening Retinal Conditions

Roche, a leader in biotechnology, has announced that the European Medicines Agency has given the green light to Vabysmo® (faricimab) 6.0 mg single-dose prefilled syringe (PFS) for treating several serious eye conditions, including neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME), and macular edema due to retinal vein occlusion (RVO). These conditions affect millions across the European Union, often leading to significant physical, emotional, and financial burdens on patients, their families, and caregivers.

The approval introduces a new, more convenient method for ophthalmologists to administer Vabysmo, providing a prefilled syringe that simplifies the treatment process. This method may help reduce the treatment burden for both patients and medical professionals dealing with these common causes of vision loss. The Vabysmo PFS is unique in its co-packaging with a CE-marked needle specifically designed for intravitreal injection, offering an alternative to the existing Vabysmo vials.

Vabysmo is notable for being the first bispecific antibody approved for use in the eye, targeting two key pathways responsible for various vision-threatening retinal diseases: angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A). By inhibiting these pathways, Vabysmo works to stabilize blood vessels, curbing vision loss by preventing the formation of new, leaky blood vessels and reducing inflammation. This innovative approach has led to its approval in over 100 countries, including the United States, Japan, the United Kingdom, and now the EU, for treating nAMD and DME, while it is also approved in more than 30 countries for RVO-related macular edema.

Since its initial approval in the US in 2022, over five million doses of Vabysmo have been distributed globally, underscoring its growing role in treating retinal conditions. The prefilled syringe format approved by the FDA in July 2024 for nAMD, DME, and RVO is now available in the EU, reinforcing its position as the only prefilled syringe containing a bispecific antibody for these serious eye conditions.

Roche's commitment to combating vision loss through pioneering treatments is reflected in its extensive pipeline of ophthalmological innovations. By leveraging advancements in scientific discovery, molecular engineering, and personalized healthcare, Roche continues to develop therapies tailored to individual patient needs. This approach is supported by insights gathered from those living with eye diseases, ensuring that new treatments align closely with patient requirements.

In addition to Vabysmo, Roche has developed breakthrough products such as Susvimo® (formerly known as the Port Delivery System with ranibizumab), a refillable ocular implant approved by the FDA for treating nAMD. This system continuously delivers a customized formulation of ranibizumab over several months, representing a significant advancement in long-term eye care. Meanwhile, Lucentis® (ranibizumab injection) was the first treatment approved to improve vision in patients with specific retinal conditions.

Founded in 1896, Roche has grown into the world's largest biotechnology company and a leader in in-vitro diagnostics. The company is dedicated to scientific excellence, aiming to discover and develop medicines and diagnostics that significantly improve and save lives. Through partnerships and the integration of data insights with its strengths in diagnostics and pharmaceuticals, Roche seeks to further transform healthcare delivery, ensuring personalized care that has a profound impact on patient lives.

Sustainability remains a core aspect of Roche's business strategy, with commitments to initiatives aiming for net zero by 2045. As a science-driven organization, Roche continues to make substantial contributions to society by developing innovative medicines and diagnostics that help people live healthier lives.