Roche announced today that the US Food and Drug Administration has approved the Vabysmo® 6.0 mg single-dose prefilled syringe for treating neovascular age-related macular degeneration, diabetic macular edema (DME), and macular edema following retinal vein occlusion (RVO). These conditions collectively affect nearly 80 million people globally. The Vabysmo PFS will soon be available to US retina specialists and their patients.

Dr. Levi Garraway, Roche’s Chief Medical Officer and Head of Global Product Development, expressed satisfaction with the FDA approval, highlighting Vabysmo's role in addressing major causes of vision loss. The new prefilled syringe format aims to simplify administration, benefiting both physicians and patients.

Vabysmo PFS delivers the same medication as the current vial format, providing a convenient, ready-to-use alternative. Vabysmo, a bispecific antibody, has demonstrated rapid vision improvements and reduced retinal swelling in nAMD, DME, and RVO cases. It targets angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A), stabilizing blood vessels crucial for maintaining vision. Globally, Vabysmo is approved in over 95 countries for nAMD and DME, with additional approvals for RVO in certain regions.

Roche continues to advance in ophthalmology with a robust pipeline focusing on innovative therapies for vision-threatening conditions, including gene therapies and treatments for diabetic eye diseases and autoimmune conditions. Their portfolio includes Susvimo® (formerly Port Delivery System with ranibizumab) and Lucentis® (ranibizumab injection), pioneering treatments that have significantly impacted vision care globally.

 

Source: globenewswire.com

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