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New Indication Alert: FDA Approves Genentech’s Susvimo® (Ranibizumab) for DME

Feb 4, 2025

On 4 February 2025, Genentech (a member of the Roche group) announced that the US FDA approved a new indication for Susvimo® (ranibizumab, 100mg/ml injection).  Susvimo® is the first and only approved continuous delivery treatment for diabetic macular oedema (DME), the leading cause of diabetes-related blindness.  Susvimo® is a refillable ocular implant containing a specialised formulation of ranibizumab.

The FDA’s approval was based on positive one-year results from the Phase 3 Pagoda study, a multicentre, randomised, active treatment-controlled, non-inferiority US-based Phase 3 study.  This study evaluated the efficacy, safety and pharmacokinetics of Susvimo® 100 mg/mL refilled every 6 months compared with monthly ranibizumab 0.5 mg intravitreal injections.

The approval follows the FDA’s acceptance of the supplemental BLA for Susvimo® in DME and diabetic retinopathy in July 2024.

The FDA had first approved Susvimo® in October 2021.  However, in October 2022, Genentech launched a voluntary recall after test results showed some implants did not perform to Genentech’s standards.  Genentech has since updated the Susvimo® implant and refill needle.  DME is the second indication approved for Susvimo®, after the FDA approved its relaunch for nAMD in July 2024.