FDA approval marks shift in diabetic retinopathy treatment

The US Food and Drug Administration (FDA) has for the first time approved a continuous delivery treatment shown to maintain the vision of patients with diabetic retinopathy with only a nine-monthly refill required. Susvimo ^® (ranibizumab injection) 100mg/mL is indicated for individuals who have previously responded to at least two anti-vascular endothelial growth factor (VEGF) injections. The treatment is delivered via a refillable ocular implant surgically inserted into the eye.

This new authorisation marks the third approval for Susvimo. The FDA approved the drug in February for diabetic macular oedema. These decisions follow the agency’s approval for wet, or neovascular age-related macular degeneration (AMD) in 2021.

The FDA’s current decision was based on positive one-year results from the Pavilion Phase III study in diabetic retinopathy. Subjects experienced a reduced severity of eye damage caused by diabetes. This was compared with individuals under monthly clinical observation who were treated with anti-VEGF injections as required. 

No participants needed supplemental treatment with Susvimo at the one-year mark, according to Genentech.

Benefit of the drug in diabetic retinopathy

Notably, Susvimo provides a continuous delivery of a customised ranibizumab formulation. Comparatively, other currently treatments can require eye injections as often as once-monthly, Genentech explained.

“The approval of Susvimo for diabetic retinopathy expands treatment options for patients, offering predictable and immediate durability after implantation with only one treatment every nine months,” stated Dr Levi Garraway, PhD, Chief Medical Officer and Head of Global Product Development, Genentech, a member of the Roche Group. “Many patients with common retinal conditions seek alternative treatment options like Susvimo that can help preserve vision with longer intervals between treatments than regular eye injections.”