FDA Approves Susvimo for Diabetic Macular Edema

The FDA has approved Genentech’s Susvimo (ranibizumab) to treat patients with diabetic macular edema (DME), a leading cause of vision loss in adults with diabetes.

Diabetic macular edema affects about 750,000 people in the United States and 29 million people globally. It occurs when damaged blood vessels in the retina leak into and cause swelling in the macula, the central area of the retina responsible for the sharp vision needed for reading and driving.

Susvimo was approved by the FDA in 2021 to treat neovascular age-related macular degeneration (AMD), an advanced form of the disease that can cause rapid and severe vision loss. Susvimo is a customized formulation of ranibizumab delivered via a refillable ocular implant, which delivers ranibizumab over time. Genentech also markets Lucentis, a ranibizumab that is administered through a direct injection into the eye.

Genentech had recalled the ocular implant, the insertion tool and initial fill kit in the United States after test results that showed some implants after repeated puncturing with a needle did not perform to standards. Genentech updated implant and refill needle, and testing confirmed that they now meet performance standards and the company reintroduced Susvimo in July 2024.

Related: Genentech Reintroduces Susvimo for Age-Related Macular Degeneration

The price of the Susvimo implant and medicine is $16,950 the first year, and two Susvimo refills every six months in year two are priced at $16,000, a company spokesperson said last year.

Genentech offers a $0 copay assistance program for the medication portion for patients with commercial insurance, with a limit of $15,000 a year. The company also provides copay assistance for administration costs with a limit of $1,000 a year. The terms say that this assistance is for the benefit of patients, and Genentech may adjust or exclude assistance if plans adjust cost sharing programs.

“Having completed dozens of Susvimo surgeries in my patients with wet, or neovascular, age-related macular degeneration, I’ve seen firsthand how Susvimo, with its continuous delivery of medication, can help preserve vision with fewer treatments,” vitreoretinal surgeon, Jordan Graff, M.D., Barnet Dulaney Perkins Eye Center, said in a news release.

The approval of Susvimo to treat patients with diabetic macular edema based on positive one-year results from the phase 3 Pagoda study. This study enrolled 634 patients, who were randomized to receive either Susvimo 100 mg/mL refilled every six months or monthly ranibizumab 0.5 mg intravitreal injections. In the Susvimo arm, participants received four loading doses of intravitreal ranibizumab before Susvimo implantation at week 16.

The primary endpoint of the study is a change in best-corrected visual acuity score (the best distance vision a person can achieve – including with correction such as glasses – when reading letters on an eye chart) from baseline at the average of week 60 and week 64.showed that Susvimo demonstrated sustained vision improvements in people with diabetic macular edema, with safety consistent with the known safety profile for Susvimo.

In Pagoda, people with diabetic macular edema who received Susvimo achieved non-inferior improvements in vision compared with those receiving monthly 0.5 mg ranibizumab intravitreal injections, according to results released by Genentech in July 2024. Approximately 95% of patients treated with Susvimo did not need additional treatment with supplemental injections during the primary analyses study of 64 weeks.

Safety data were consistent with the known safety profile for Susvimo.