FDA Approves Roche’s Vabysmo Syringe for Major Vision Loss Causes

Roche has announced that the United States Food and Drug Administration (US FDA) has approved the Vabysmo® (faricimab) 6.0 mg single-dose prefilled syringe (PFS) for treating neovascular or ‘wet’ age-related macular degeneration (nAMD), diabetic macular edema (DME), and macular edema following retinal vein occlusion (RVO). These conditions collectively impact nearly 80 million people globally. The Vabysmo PFS will be available to retina specialists and their patients in the United States in the coming months.

Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head of Global Product Development at Roche, expressed satisfaction with the FDA's approval, noting that this new prefilled syringe format would simplify the administration process for both physicians and patients. While many retina specialists already use Vabysmo as a first-line treatment, the PFS format is expected to enhance the treatment experience further.

The Vabysmo PFS offers the same medication as the currently available Vabysmo vials but in a more convenient, ready-to-use format. The medicine will continue to be available in a 6.0 mg vial as well. Vabysmo is the first bispecific antibody approved for the eye, known for its rapid and robust improvements in vision and retinal drying in patients with nAMD, DME, and RVO. Retinal drying is a critical clinical measure because swelling from excess fluid in the back of the eye can lead to distorted and blurred vision.

As of now, Vabysmo has received approval in more than 95 countries for nAMD and DME, and in several countries, including the US and Japan, for RVO. The review process by other health authorities worldwide is ongoing. Since its initial US approval in 2022, over four million doses of Vabysmo have been distributed globally.

Vabysmo is unique as it is the first bispecific antibody approved for ocular use. It targets and inhibits two signaling pathways—angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A)—that are linked to several vision-threatening retinal conditions. By neutralizing Ang-2 and VEGF-A, Vabysmo aims to stabilize blood vessels, thereby preventing vision loss caused by the formation of new leaky blood vessels and increased inflammation.

Roche is committed to combating the leading causes of vision loss through innovative therapies. The company's efforts in scientific discovery, personalized healthcare, molecular engineering, biomarkers, and continuous drug delivery focus on designing the right treatments for the right patients. Roche boasts one of the most extensive retina pipelines in ophthalmology, encompassing gene therapies and treatments for multiple vision-threatening conditions, including diabetic eye diseases, geographic atrophy, and autoimmune conditions like thyroid eye disease and uveitic macular edema.

Leveraging its extensive experience, Roche has introduced breakthrough ophthalmic treatments for those suffering from vision loss. Susvimo® (previously known as Port Delivery System with ranibizumab) was approved by the US FDA in 2021. Vabysmo® is recognized for targeting and inhibiting two significant signaling pathways related to retinal conditions. Another notable treatment, Lucentis® (ranibizumab injection), was the first approved therapy to improve vision in individuals with certain retinal conditions.

Founded in 1896 in Basel, Switzerland, Roche has evolved into the world's largest biotechnology company and a global leader in in-vitro diagnostics. The company is dedicated to scientific excellence, aiming to discover and develop medicines and diagnostics that improve and save lives worldwide. Roche is a pioneer in personalized healthcare and seeks to transform healthcare delivery for greater impact. The company collaborates with various stakeholders, combining strengths in Diagnostics and Pharma with clinical data insights to provide optimal care for each individual.

Recognized for its long-term perspective, Roche has been named one of the most sustainable companies in the pharmaceuticals industry by the Dow Jones Sustainability Indices for fifteen consecutive years. This acknowledgment reflects Roche's commitment to improving healthcare access worldwide through local partnerships.

Genentech, a member of the Roche Group, operates in the United States, and Roche is the majority shareholder in Chugai Pharmaceutical, Japan.