General Information

Susvimo (ranibizumab injection) is a vascular endothelial growth factor (VEGF) inhibitor.

Susvimo is specifically indicated for intravitreal use via Susvimo ocular implant for the treatment of patients with Neovascular (wet) Age-related Macular Degeneration (AMD) who have previously responded to at least two intravitreal injections of a VEGF inhibitor.

The recommended dose of Susvimo (ranibizumab injection) is 2 mg (0.02 mL of 100 mg/mL solution) continuously delivered via the Susvimo implant with refills every 24 weeks (approximately 6 months). Supplemental treatment with 0.5 mg intravitreal ranibizumab injection may be administered in the affected eye if clinically necessary. Perform the initial implantation, refill-exchange, and implant removal (if necessary) procedures under strict aseptic conditions.

Mechanism of Action

Susvimo (ranibizumab injection) binds to the receptor binding site of multiple biologically active forms of VEGF-A, including VEGF110. VEGF-A has been shown to cause neovascularization and leakage in models of ocular angiogenesis and vascular occlusion and is thought to contribute to pathophysiology of neovascular AMD. The binding of ranibizumab to VEGF-A prevents the interaction of VEGF-A with its receptors (VEGFR1 and VEGFR2) on the surface of endothelial cells, reducing endothelial cell proliferation, vascular leakage, and new blood vessel formation.

Side Effects

Adverse effects associated with the use of Susvimo may include, but are not limited to, the following:

• conjunctival hemorrhage
• conjunctival hyperemia
• iritis
• eye pain

Clinical Trial Results

FDA approval was based on Archway, a randomized, multicenter, open-label Phase III study evaluating the efficacy and safety of Susvimo (ranibizumab injection) 100 mg/mL for intravitreal use via ocular implant administered via the Susvimo eye implant, refilled every six months at fixed intervals, compared to monthly intravitreal injections of ranibizumab 0.5 mg in 415 people living with wet age-related macular degeneration (AMD). Patients enrolled in Archway were responders to prior treatment with anti-vascular endothelial growth factor (VEGF) therapy. 

The primary analysis showed wet AMD patients treated with Susvimo achieved and maintained vision gains equivalent to monthly ranibizumab injections – +0.2 and +0.5 eye chart letters from baseline, respectively – at weeks 36 and 40 of treatment. In addition, only 1.6% of Susvimo patients received supplemental ranibizumab treatment before their first refill, and more than 98% could go six months before their first refill.