FDA accepts application for Vabysmo for the treatment of retinal vein occlusion.- Genentech/Roche

The sBLA is based on results from the Phase III BALATON and COMINO studies that demonstrated treatment with Vabysmo provided early and sustained improvement in vision, meeting the primary endpoint of non-inferior visual acuity gains at 24 weeks compared to aflibercept. Vabysmo’s safety profile was consistent with previous trials.

“This acceptance brings us one step closer to delivering Vabysmo as a treatment for retinal vein occlusion, a disease that affects more than one million people in the United States and can cause severe and sudden vision loss,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “If approved, this would be the third indication for Vabysmo, the first bispecific antibody available for the treatment of retinal conditions that can cause blindness.”

The data from the BALATON and COMINO studies will be submitted to other health authorities around the world, including the European Medicines Agency, for approval for the treatment of macular edema following RVO. The studies are ongoing, and data from weeks 24 to 72 will assess the potential of Vabysmo to extend dosing intervals up to every four months.

Vabysmo is the first bispecific antibody approved for the eye and was approved in the United States for the treatment of wet, or neovascular, age-related macular degeneration (AMD) and diabetic macular edema (DME) in January 2022. Vabysmo is approved in 60 countries, including Japan, the United Kingdom, and in the European Union, for wet AMD and DME. Wet AMD, DME, and RVO together affect around three million people in the United States and are among the leading causes of vision loss. Vabysmo’s efficacy and safety profile in wet AMD and DME is supported by four large, global studies involving more than 3,000 participants and extensive real world experience, with nearly one million doses distributed globally. Vabysmo is the only injectable eye medicine approved for wet AMD and DME by the FDA with the option for treatments from one to four months apart in the first year following four initial monthly loading doses, based on evaluation of the patient’s anatomy and vision outcomes. It targets and inhibits two disease pathways linked to a number of vision-threatening retinal conditions by neutralizing angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A).