FDA

Susvimo approved for diabetic retinopathy

May 28, 2025

FDA approved Susvimo (ranibizumab injection) for the treatment of patients with diabetic retinopathy who’ve previously responded to ≥2 intravitreal injections of a vascular endothelial growth factor (VEGF) inhibitor.

Susvimo is a VEGF inhibitor that’s indicated for use via the Susvimo ocular implant.

Efficacy

Approval for diabetic retinopathy was supported by data from the phase 3 PAVILION study (NCT04503551) involving 174 patients with moderately-severe to severe non-proliferative diabetic retinopathy (NPDR), without center-involved diabetic macular edema (CI-DME). Participants who hadn’t received prior treatment in the study eye for diabetic retinopathy were randomly assigned to receive Susvimo via the implant q36wks (n=106) or to clinical observation (n=68). Primary endpoint was the proportion of patients with ≥2-step improvement from baseline on the Early Treatment Diabetic Retinopathy Study Diabetic Retinopathy Severity Score (ETDRS-DRSS).

At week 52, the rate of the primary endpoint was 80% in the Susvimo group vs. 9% in the clinical observation group (treatment difference, 71%; 95% confidence interval, 61-81).

For patients in either arm who developed CI-DME or proliferative diabetic retinopathy/anterior segment neovascularization, supplemental treatment with intravitreal injections of ranibizumab 0.5mg were available per investigator’s clinical judgement. Through week 52, none of the patients in the Susvimo arm received supplemental treatment, whereas 40% of the observational comparator arm received ≥1 supplemental treatments.

Safety

The most common adverse reactions (≥10%) were conjunctival hemorrhage, conjunctival hyperemia, iritis, eye pain, cataract, conjunctival disorder, and vitreous hemorrhage.

Recommended dose

The recommended dosage of Susvimo for patients with diabetic retinopathy is 2mg continuously delivered via the ocular implant with refills q36wks (approximately 9 months).

Sources:

FDA approves Genentech’s Susvimo for diabetic retinopathy. [News release]. 2025. https://www.gene.com/media/press-releases/15062/2025-05-22/fda-approves-genentechs-susvimo-for-diab

Susvimo (ranibizumab injection) [package insert]. Genentech. https://www.gene.com/download/pdf/susvimo_prescribing.pdf Revised May 2025. Accessed May 23, 2025.