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FDA Accepts Roche’s sBLA For Susvimo® (Ranibizumab) for DME and DR

Jul 18, 2024

On 18 July 2024, Roche announced that FDA has accepted its supplemental BLA for Susvimo®, a refillable ocular implant containing a specialised formulation of ranibizumab, for the treatment of diabetic macular oedema (DME) and diabetic retinopathy (DR).

This follows the FDA’s approval of the relaunch of Susvimo® for nAMD earlier this month.

Also on 18 July 2024, Roche announced two-year data from the Phase III Pagoda and Pavilion studies evaluating Susvimo® for DME and DR, with Susvimo® demonstrating sustained efficacy over that period and safety consistent with the known safety profile for Susvimo® in patients with DME and DR.