FDA Approves Genentech’s Susvimo for Treating Wet AMD

The US Food & Drug Administration (FDA) has approved Susvimo^TM, Genentech’s port delivery system (PDS) with ranibizumab, for the treatment of wet age-related macular degeneration (AMD). The PDS, a refillable capsule the size of a rice grain, provides continual release of ranibizumab, a protein that blocks the growth of vision-robbing, leaky blood vessels which are the hallmark of wet AMD. The PDS is implanted at the surface of the eye during a one-time, outpatient, surgical procedure. The PDS may be refilled as infrequently as twice a year. Susvimo will be available to patients in the coming months.

In contrast, other FDA-approved wet AMD therapies —including Lucentis^® (ranibizumab) and Eylea^® (aflibercept) — are injected into the vitreous (soft gel in the middle of the eye) on a regular basis, usually several times a year.

In Genentech’s Phase 3 Archway clinical trial for Susvimo, 98 percent of participants were able to go six months before their first PDS refill. In addition, only 1.6 percent of patients required rescue intravitreal injections of Lucentis.

“Though current FDA-approved wet AMD therapies are safe and often save vision, they require regular ocular injections at a doctor’s office for the life of the patient,” says Claire Gelfman, PhD, chief scientific officer at the Foundation Fighting Blindness. “Susvimo offers patients the opportunity to significantly reduce that treatment burden.”

AMD is the leading cause of blindness in people 55 and older in developed countries, affecting 11 million people in the US. More than 1 million people in the US have wet AMD. Major AMD risk factors include: advancing age, smoking, and genetics.

There are two forms of AMD — dry and wet. Virtually all AMD patients start off with the dry form, which is characterized by the accumulation of deposits known as drusen underneath the macula (central region of the retina). Many people with dry AMD never lose significant vision. Some develop geographic atrophy, the advanced form of dry AMD, which causes loss of retinal cells and central vision. Some people with dry AMD develop the wet form, which more quickly causes central vision loss from the growth of damaging leaky blood vessels underneath the retina.