FDA Approves Genentech’s Susvimo for Wet AMD

Genentech, a member of the Roche Group, announced on Oct. 22nd, 2021, that FDA had approved Susvimo (100 mg/mL ranibizumab injection) for the treatment of wet, or neovascular, age-related macular degeneration (AMD), a condition that can lead to rapid and severe loss of vision. Susvimo is approved for intravitreal use via ocular implant for patients who have previously responded to at least two anti-vascular endothelial growth factor (VEGF) injections.

According to a company press release, Susvimo is the first and only FDA-approved treatment for wet AMD that offers as few as two treatments per year. Patients with wet AMD may need anti-VEGF injections as often as once a month, but Genentech’s treatment delivers ranibizumab continuously following a one-time implant that is refilled approximately every six months.

This approval was made following results from the Archway study, a randomized, multicenter, open-label Phase III study that evaluated Susvimo relative to monthly ranibizumab injections. It measured best-corrected visual acuity scores (the best distance vision a person can achieve when reading letters on an eye chart) following 36–40 weeks of treatment. Per pre-specified study criteria, Susvimo was found to be non-inferior to monthly injections; patients who were given monthly injections gained 0.5 letters on average, while those who received injections via Susvimo gained 0.2 letters.

“Susvimo represents a major advancement in the treatment of retinal disease and is an important new option for patients with wet AMD,” said Carl Regillo, chief of retina service at Wills Eye Hospital in Philadelphia and an Archway study investigator, in the press release. “With Susvimo, my patients now have an option that can help them maintain their vision as well as anti-VEGF injections, but on a more manageable twice-yearly treatment schedule.”

Source: Genentech