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FDA Accepts Application for Genentech’s Vabysmo for Retinal Vein Occlusion

FDA Accepts Application for Genentech’s Vabysmo for Retinal Vein Occlusion

May 10, 2023

Genentech announced that the FDA has accepted the company's supplemental biologics license application (sBLA) for Vabysmo (faricimab-svoa) for the treatment of macular edema following retinal vein occlusion (RVO).

The sBLA is based on data from the phase 3 BALATON and COMINO studies, which demonstrated that Vabysmo treatment showed early and sustained improvement in vision, and met the primary endpoint of non-inferior visual acuity gains at 24 weeks compared to aflibercept. The safety profile of Vabysmo was consistent with previous clinical 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,” Levi Garraway, M.D., PhD, chief medical officer and head of Global Product Development, said in a company news release. “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 ongoing BALATON and COMINO studies will be submitted to other health authorities globally, including the European Medicines Agency, for approval for the treatment of macular edema following RVO. Additionally, further data from weeks 24 to 72 will evaluate the potential of Vabysmo to extend dosing intervals up to every 4 months.

Vabysmo, the first bispecific antibody approved for the eye, received approval in the United States for the treatment of wet 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 the European Union, for wet AMD and DME. Wet AMD, DME, and RVO together impact approximately three million people in the United States and are among the leading causes of vision loss.

Vabysmo has been proven safe and effective in the treatment of wet AMD and DME based on four large global studies involving over 3,000 participants, and extensive real-world experience, with nearly one million doses distributed worldwide. Vabysmo is the only injectable eye medicine for wet AMD and DME approved by the FDA that allows for treatments spaced between one and four months apart within the first year after four initial monthly loading doses. This option is based on the evaluation of the patient's anatomy and vision outcomes.

Vabysmo targets and inhibits two disease pathways linked to a range of retinal conditions that threaten vision by neutralizing angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A).