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FDA approves Roche’s Vabysmo to treat nAMD and DME

Vabysmo is the only injectable eye medicine approved simultaneously in the US for neovascular Age-related Macular Degeneration (nAMD) and Diabetic Macular Edema (DME)

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Roche yesterday announced that the US Food and Drug Administration (FDA) has approved Vabysmo (faricimab-svoa) for the treatment of neovascular or “wet” Age-related Macular Degeneration (nAMD) and Diabetic Macular Edema (DME). Neovascular AMD and DME are two leading causes of vision loss worldwide.

A statement from the company said that Vabysmo targets and inhibits two disease pathways linked to a number of vision-threatening retinal conditions by neutralising angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A). It is the first and only FDA-approved injectable eye medicine for nAMD and DME that improves and maintains vision with treatments from one-to-four months apart in the first year following four initial monthly doses, based on evaluation of the patient’s anatomy and vision outcomes.

“Vabysmo represents an important step forward for ophthalmology. It is the first bispecific antibody approved for the eye and a major advance in treating retinal conditions such as nAMD and DME,” said Charles Wykoff, MD, PhD, Director, Research, Retina Consultants of Texas, Houston and a Vabysmo phase-III investigator, in the statement.

He added, “With Vabysmo, we now have the opportunity to offer patients a medicine that could improve their vision, potentially lowering treatment burden with fewer injections over time.”

The statement further noted that the approval is based on positive results across four phase-III studies in nAMD and DME. The studies consistently showed that patients treated with Vabysmo given at intervals of up to four months achieved non-inferior vision gains versus aflibercept given every two months in the first year. Vabysmo was generally well-tolerated in all four studies, with a favourable benefit-risk profile. The most common adverse reaction (≥5%) reported in patients receiving Vabysmo was conjunctival hemorrhage (seven per cent). Two scientific papers and an editorial on these one-year results were recently published in The Lancet.

Vabysmo will be available in the United States in the coming weeks. The European Medicines Agency (EMA) is also currently evaluating the Vabysmo marketing authorisation application for the treatment of nAMD and DME, the statement concluded.

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