FDA Approves Vabysmo, The First Bispecific Antibody For The Eye!

On 28 January, the US Food and Drug Administration approved Vabysmo (faricimab-svoa), for the treatment of wet age-related macular degeneration (AMD) and diabetic macular oedema (DME).

Vabysmo is a bispecific monoclonal antibody that targets and inhibits many vision-threatening retinal diseases caused by both angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A) pathways by neutralising both pathways.

Vabysmo is the first and only FDA-approved injectable ophthalmic drug for wet AMD and DME to improve and maintain vision with treatments spaced one to four months apart during the first year after the initial four-month dose, based on an assessment of the patient's anatomy and visual outcomes.

"Vabysmo offers a new approach to treating vision-threatening retinal diseases through a mechanism of action that targets both pathways," said Dr. Levi Garraway, Chief Medical Officer and Head of Global Product Development, "Vabysmo is our second FDA-approved ophthalmic treatment in recent months, which underscores our commitment to patients suffering from retinal disease."

Clinical trial presentation
Vabysmo's approval was based on positive results from four Phase III studies in wet AMD and DME.

The studies consistently showed that patients treated with Vabysmo given at intervals of up to four months achieved visual efficacy ≥ abciximab compared to abciximab given every two months during the first year.

Vabysmo was generally well tolerated in all four studies, with only ≥5% of common adverse reactions reported in patients receiving Vabysmo.

Patients with wet AMD on Vabysmo initially received treatment four times per month. They may receive follow-up treatment every two or three or four months, depending on anatomical and visual acuity test results.

Patients with DME initially receive 4 treatments per month. Subsequently, their treatment may be extended or reduced depending on the results of anatomical and vision tests, with dose adjustments ranging from one to four months.

"Vabysmo represents an important step forward for ophthalmology. It is the first bispecific antibody approved for use in the eye and a major advance in the treatment of retinal diseases such as wet AMD and DME," said Charles Wykoff, PhD, director of the Vabysmo Phase III study at Retina Consultants Research Center in Houston, Texas. "With Vabysmo, we now have the opportunity to provide patients with drugs that can improve their vision and, over time, potentially reduce the burden of treatment by reducing the number of injections."