The “first and only” continuous delivery treatment to treat diabetic retinopathy (DR) has been approved by the United States Food and Drug Administration (US FDA).1
Genentech’s Susvimo (ranibizumab) can help people with DR maintain their vision and prevent progression to blindness with only one treatment every nine months, delivered via the Port Delivery Platform.
The Port Delivery Platform is a refillable eye implant surgically inserted into the eye during a one-time outpatient procedure, which introduces medicine directly into the eye. It is the third FDAapproved indication for Susvimo, which is also approved in the US for treating neovascular age-related macular degeneration and diabetic macular oedema.
“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,” said Dr Levi Garraway, Genentech’s chief medical officer and head of Global Product Development. The FDA decision was based on positive one-year results from the Phase 3 Pavilion study.
People with DR who received Susvimo refilled every nine months achieved superior improvements on the Diabetic Retinopathy Severity Scale (DRSS). This means there was a reduction in the severity of eye damage caused by diabetes, compared with those under monthly clinical observation who were treated with anti-VEGF injections as needed based on disease progression. Additionally, none of the participants receiving Susvimo required supplemental treatment at one year. Safety was consistent with the known safety profile for Susvimo.
Reference available at mivision.com.au.