FDA Approves Vabysmo for Treatment of 2 Leading Causes of Vision Loss

The FDA has approved faricimab-svoa (Vabysmo, Roche) for the treatment of diabetic macular edema (DME) and neovascular or “wet” age-related macular degeneration (nAMD), which are 2 leading causes of vision loss worldwide.

Vabysmo targets and inhibits 2 disease pathways that are linked to several vision-threatening retinal conditions by neutralizing angipoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A).

Vabysmo is the first and only FDA-approved injectable eye medicine for DME and nAMD and maintains vision with treatments from 1 to 4 months apart in the first year following 4 initial monthly doses.

The standard of care for DME and nAMD usually requires eye injections every 1 to 2 months.

“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 neovascular AMD and diabetic macular edema,” Charles Wykoff, MD, PhD, director of research at Retina Consultants of Texas in Houston, said in a statement. “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 approval is based on positive results across 4 phase 3 studies in DME and nAMD. The study results consistently showed that individuals treated with Vabysmo at different intervals of up to 4 months achieved non-inferior vision gains versus aflibercept given every 2 months after the first year.

Vabysmo was generally well tolerated in all 4 studies with a favorable benefit-risk profile. The most common adverse event was conjunctival hemorrhage.

Faricimab-svoa was designed to block pathways involving Ang-2 and VEGF-A. Ang-2 and VEGF-A are thought to contribute to vision loss by destabilizing blood vessels, which may cause new leaky blood vessels to form and increase inflammation.

Roche recently had 2 scientific papers published in The Lancet to highlight the 1-year results from the 4 pivotal phase 3 studies.

With Vabysmo, individuals with nAMD initially receive 4 monthly treatments. Based on anatomical and vision outcomes, they may receive subsequent treatments every 2, 3, or 4 months. Individuals with DME are initially given 4 monthly treatments. Subsequently, their treatment may be extended or reduced based on anatomical and vision outcomes, with a range of 1 to 4 months between doses. A second approved treatment regimen for DME involves 6 monthly loading doses, followed by treatment every 2 months. Some people with DME and nAMD may be treated monthly if needed, though additional efficacy was not demonstrated in most individuals given Vabysmo every month.Roche has ongoing long-term extension studies for Vabysmo in individuals with DME and nAMD. AVONELLE-X is an extension study of TENAYA and LUCERNE evaluating the long-term safety and tolerability of Vabysmo in nAMD, while RHONE-X, an extension study of YOSEMITE and RHINE is evaluating the long-term safety and tolerability of faricimab-svoa in DME.

Additionally, the COMINO and BALATON trials are under way to evaluate the efficacy and safety of the drug for individuals with macular edema following retinal vein occlusion.

Vabysmo will be available in the United States in the coming weeks.

Reference

FDA approves Roche’s Vabysmo, the first bispecific antibody for the eye, to treat two leading causes of vision loss. News release. Roche. January 31, 2022. Accessed January 31, 2022. Email.