Published in Archives

Another new FDA approval. — Weekly Glance

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The FDA has approved Genentech's Vabysmo [va-bis-mo] for the treatment of wet age-related macular degeneration (AMD) and diabetic macular edema (DME), making it the first bispecific antibody approved for ophthalmic use.

What is a bispecific antibody?

Bispecific antibodies are antibodies with two binding sites directed at two different antigens or two different epitopes on the same antigen. (via)

Vabysmo targets and inhibits two disease pathways:

1. Neutralizing angiopoietin-2 (Ang-2)

2. Vascular endothelial growth factor-A (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.

How often are injections given?

Vabysmo improves and maintains visual acuity when treatment is administered 1 to 4 months apart in the first year after four initial monthly doses, based on evaluation of the patient’s anatomy and vision outcomes.

What about the clinical trials?

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 compared with aflibercept (Eylea) given every 2 months in the first year.

Any adverse events?

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%).

Any word on cost?

According to Genentech, Vabysmo will cost $2,190 per treatment. For patients who can go up to 4 months between treatments, Vabysmo will cost $13,140 for the first year, including four initial monthly doses. Each year after, the annual price drops to $6,570. (via)