FDA Approves Genentech’s Vabysmo, the First Bispecific Antibody for the Eye, to Treat Wet AMD and DME

The FDA has approved Genentech's Vabysmo (faricimab-svoa) for the treatment of wet age-related macular degeneration (AMD) and diabetic macular edema (DME), marking the first bispecific antibody approved for the eye. 

Vabysmo is also the first and only FDA-approved injectable eye medicine for wet AMD and DME that improves and maintains vision with treatments from 1 to 4 months apart in the first year following 4 initial monthly doses, based on evaluation of the patient’s anatomy and vision outcomes. Standard of care for wet AMD and DME typically requires eye injections every 1 to 2 months.

Vabysmo 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). 

“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 wet AMD and diabetic macular edema,” Charles Wykoff, MD, PhD, Director of Research at Retina Consultants of Texas in Houston and a Vabysmo phase 3 investigator, said in a company news release. “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.”

In a statement to Eyewire News, Genentech said the price of Vabysmo is $2,190 per treatment. For patients who can go up to 4 months between treatments, the price of Vabysmo would be $13,140 for the first year, including four initial monthly doses. Each year after, the annual price drops to $6,570.

The approval is based on positive results across four phase 3 studies in wet AMD and DME. The studies consistently showed that patients treated with Vabysmo given at intervals of up to 4 months achieved noninferior vision gains versus aflibercept given every 2 months in the first year. Vabysmo was generally well tolerated in all four studies, with a favorable benefit-risk profile. The most common adverse reaction (≥5%) reported in patients receiving Vabysmo was conjunctival hemorrhage (7%).

Two scientific papers and an editorial on these 1-year results were recently published in The Lancet. EyewireTV's coverage of the 1-year results can be found here. 

Vabysmo is 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. While additional research continues, inhibition of both pathways has been shown in preclinical studies to have potentially complementary benefits, stabilizing vessels and thereby reducing vessel leakage and inflammation.

“Vabysmo provides a new approach to treating vision-threatening retinal conditions through a mechanism of action that targets two pathways simultaneously,” said Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development. “This is our second FDA approval in ophthalmology in recent months, underscoring our commitment to people living with retinal conditions.”

With Vabysmo, people with wet AMD initially receive 4 monthly treatments. Based on anatomical and vision outcomes, they may receive subsequent treatments every 2, 3 or 4 months. People 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 wet AMD and DME may be treated monthly if needed, although additional efficacy was not demonstrated in most patients given Vabysmo every month.

Genentech has ongoing long-term extension studies for Vabysmo in people with wet AMD and DME. These include AVONELLE-X, an extension study of TENAYA and LUCERNE evaluating the long-term safety and tolerability of Vabysmo in wet AMD; and RHONE-X, an extension study of YOSEMITE and RHINE evaluating the long-term safety and tolerability of Vabysmo in DME. Additionally, the COMINO and BALATON trials are also underway, evaluating the efficacy and safety of Vabysmo in people with macular edema following retinal vein occlusion.

Vabysmo will be available in the United States in the coming weeks. The European Medicines Agency is also currently evaluating the Vabysmo Marketing Authorization Application for the treatment of wet AMD and DME.

Genentech is committed to helping people access the medicines they are prescribed and will be offering comprehensive services for people prescribed Vabysmo to help minimize barriers to access and reimbursement. Patients can call 833-EYE-GENE for more information. For people who qualify, Genentech plans to offer patient assistance programs through Genentech Access Solutions. More information is also available at 866-4ACCESS/866-422-2377 or http://www.Genentech-Access.com.