The US Food and Drug Administration (FDA) has approved Roche’s subsidiary Genentech’s Susvimo for the treatment of diabetic retinopathy (DR), a condition which is estimated to affect nearly 10 million individuals in the US.
Susvimo, a ranibizumab injection, features a continuous delivery system that requires only one refill every nine months. This approach may reduce the need for frequent treatments and assist in maintaining vision while preventing the progression to blindness.
Its latest FDA approval is based on data from the Phase III Pavilion study.
The trial demonstrated that patients receiving Susvimo showed superior improvement on the Diabetic Retinopathy Severity Scale (DRSS) compared to those under monthly observation who received anti-vascular endothelial growth factor (VEGF) injections as needed.
Importantly, none of the participants using Susvimo required additional treatment at the one-year mark. The safety profile was consistent with previous findings.
Susvimo utilises the Port Delivery Platform, offering an alternative to regular eye injections currently employed in other treatments. This platform involves a refillable ocular implant inserted surgically during an outpatient procedure, allowing direct delivery of medication into the eye.
The ranibizumab formulation in Susvimo acts by inhibiting VEGF-A, a protein associated with blood vessel formation and permeability.
Genentech chief medical officer and global product development head Levi Garraway said: “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.”
This FDA approval marks the third indication for Susvimo, which is also sanctioned for treating wet or neovascular age-related macular degeneration and diabetic macular oedema.
The implications of this approval extend to retina specialists across the US, who can now access this treatment option for patients who have previously responded to anti-VEGF injections.
The Pavilion study involved 174 participants with diabetic retinopathy but without centre-involved diabetic macular oedema. Participants were randomised in a 5:3 ratio to receive either Susvimo refills every nine months or monthly clinical observation.
Those in the Susvimo group initially received two loading doses of ranibizumab before implant insertion at week four. The primary endpoint focused on achieving a two-step improvement from baseline on the Early Treatment DRSS after 52 weeks.
