Novel drug approved for diabetes-related vision loss

The US Food and Drug Administration (FDA) has approved Genentech’s Susvimo ^® (ranibizumab injection) 100 mg/mL as the first treatment for diabetic macular oedema (DME) via continuous delivery.

“Susvimo, with its continuous delivery of medication, can help preserve vision with fewer treatments,” explained vitreoretinal surgeon, Dr Jordan Graff, Barnet Dulaney Perkins Eye Center, US.

This drug option “presents a unique, convenient treatment alternative to routine eye injections for people with a potentially blinding diabetic eye condition,” stated Dr Levi Garraway, PhD, Chief Medical Officer and Head of Global Product Development.

The treatment delivers a continuous dose of a customised ranibizumab formulation via the Port Delivery Platform. Patients may only need two treatments annually, while other currently approved treatments may require monthly eye injections, Genentech noted.

It is indicated for these individuals who have had a prior response to at least two intravitreal injections of a Vascular Endothelial Growth Factor (VEGF) inhibitor medication. As a VEGF inhibitor, ranibizumab inhibits VEGF-A, a protein shown to have a key role in new blood vessel formation and the leakiness of the vessels Genentech added.

Data supporting the approval of Susvimo as a novel treatment for diabetic macular oedema

The FDA decision was based on positive one-year results from the Phase III Pagoda study. Susvimo demonstrated sustained vision improvements in diabetic macular oedema.

Participants who received the treatment refilled every six months achieved non-inferior improvements in vision compared with those given monthly 0.5mg ranibizumab intravitreal injections (9.6 eye chart letters, similar to gaining two more lines on an eye chart, compared to 9.4 letters, respectively). In the Susvimo arm, participants received four loading doses of intravitreal ranibizumab before Susvimo implantation at week 16.

The FDA first authorised Susvimo for wet, or neovascular age-related macular degeneration (AMD) in 2021, Genentech shared.