FDA Approves Novel Therapy for Macular Degeneration

Genentech’s Susvimo is a refillable implant that delivers medication continuously for up to six months.

The FDA has approved Genentech’s Susvimo (ranibizumab) for the treatment of patients with wet, age-related macular degeneration (AMD). Susvimo is a refillable ocular implant that delivers ranibizumab continuously, offering people living with wet AMD an alternative to anti-VEGF eye injections needed as often as once a month. The implant is surgically inserted into the eye during a one-time, outpatient procedure and refilled every six months.

“Susvimo represents a major advancement in the treatment of retinal disease, and is an important new option for patients with wet AMD,” Carl Regillo, M.D., chief of retina service at Wills Eye Hospital in Philadelphia and study investigator, said in a statement.

The approval is based on positive results from the phase 3 Archway study primary analysis, which showed wet AMD patients treated with Susvimo achieved and maintained vision gains equivalent to monthly ranibizumab injections at weeks 36 and 40 of treatment. More than 98% of patients could go six months before their first refill of ranibizumab.

Susvimo was generally well-tolerated, but the implant was associated with a three-fold higher rate of infections compared with monthly intravitreal injections of ranibizumab. In clinical trials, 2% of patients with an implant experienced at least one episode of endophthalmitis.

Many of these events were associated with conjunctival retractions or erosions. Conjunctival retractions and erosions involve the layer (conjunctiva) that covers the white part of the eye, which may cause the implant to be exposed. Both of these events may require surgery.

In clinical trials, the most common adverse events were conjunctival hemorrhage, conjunctival hyperemia, iritis and eye pain.

Age-related macular degeneration is a condition that affects the macula, the part of the eye that provides sharp, central vision needed for activities like reading, and is a leading cause of blindness for people aged 60 and over in the United States. Wet, or neovascular, AMD is an advanced form of the disease that can cause rapid and severe vision loss. About 11 million people in the United States have some form of AMD, and of those, about 1.1 million have wet AMD.