Feb. 6, 2025 — The FDA has approved a new implantable treatment for adults with diabetic macular edema (DME) after studies showed that it could help maintain vision with as few as two treatments per year.
Sold as Susvimo, it's the first device that slowly releases ranibizumab, a medicine that treats eye diseases, so patients don’t need frequent injections.
DME affects about 750,000 people in the United States and 29 million globally. High blood sugar can damage tiny blood vessels in the eyes, causing fluid leakage and swelling in the macula — the part of the eye responsible for clear vision. This swelling can lead to serious vision problems or blindness, and treatments often involve monthly injections, highlighting the need for more convenient options.
Susvimo is a tiny, refillable device that delivers ranibizumab directly to the eye. It’s implanted during an outpatient procedure and slowly releases the medication over six months, reducing the need for monthly injections. Ranibizumab helps reduce swelling in the macula by blocking a protein called VEGF-A, which causes harmful blood vessels to grow in the eye.
DME is the second approved use for Susvimo, following its 2021 approval for wet (neovascular) age-related macular degeneration. The ranibizumab injection (Lucentis) was first approved in 2006.
The FDA approval was based on results from a clinical trial that included 634 patients with DME. Patients were randomly assigned to receive either Susvimo refilled every six months or monthly ranibizumab eye injections. After a year, both groups had similar improvements in vision. The safety of Susvimo was similar to that reported in previous trials, with no new concerns, according to Genentech, the drug’s maker.
The most common side effects include eye redness, light sensitivity, and eye pain. Using the Susvimo implant and related procedures, like inserting, filling, and removing it, can also cause side effects. Compared with monthly ranibizumab injections, Susvimo has three times the risk of serious eye infections. These infections, called endophthalmitis, can cause vision loss if not treated quickly.
It is unknown whether the drug harms an unborn baby or passes into breast milk. The maker has advised patients to use birth control during treatment and for 12 months after the last refill of Susvimo.
