Roche and member company Genentech today announced the U.S. Food and Drug Administration (FDA) has approved Susvimo® (ranibizumab injection) 100 mg/mL, a new treatment for diabetic retinopathy (DR). This is an important step forward for approximately 10 million individuals in the U.S. with this potentially blinding disease.
Susvimo is the first and sole FDA-approved continuous delivery therapy that has shown to be able to preserve vision in individuals suffering from diabetic retinopathy with only a single refill every nine months. This represents a significant advancement over available therapies that need eye injections as often as monthly. The approval is for individuals suffering from DR who have had prior response to at least two anti-vascular endothelial growth factor (VEGF) injections.
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,
Many patients with common retinal conditions seek alternative treatment options like Susvimo that can help preserve vision with longer intervals between treatments than regular eye injections.
Levi Garraway
The FDA based its decision on positive one-year results of the Phase III Pavilion study (NCT04503551). This multicenter, randomized US study compared the efficacy, safety, and pharmacokinetics of Susvimo refilled every nine months with monthly clinical observation in 174 individuals with diabetic retinopathy. The study indicated that subjects treated with Susvimo demonstrated greater improvement on the Diabetic Retinopathy Severity Scale (DRSS).
Susvimo employs a Port Delivery Platform, a refillable implant that is implanted in the eye during an outpatient surgery. It perpetually administers an individually tailored formulation of ranibizumab, a VEGF inhibitor that binds to and blocks VEGF-A, a protein that plays a central role in the growth of new, leaky blood vessels.
The FDA has already authorized Susvimo for the treatment of diabetic macular edema (DME) and neovascular or “wet” age-related macular degeneration (AMD), making diabetic retinopathy its third approved indication.
About Susvimo®
In a single, outpatient surgery, a refillable eye implant called Susvimo is surgically placed into the eye. Over time, Susvimo consistently provides a customized ranibizumab formulation. Vascular endothelial growth factor (VEGF) inhibitor ranibizumab is made to attach to and block VEGF-A, a protein that has been demonstrated to be essential for both the development of new blood vessels and the permeability of existing ones.
Susvimo’s customized ranibizumab formulation is distinct from ranibizumab intravitreal injection, which is sold under the brand name Lucentis® (ranibizumab injection)* and is authorized to treat neovascular or “wet” age-related macular degeneration (nAMD) as well as other retinal disorders. The US Food and Drug Administration initially authorized Lucentis for AMD in 2006. Additionally, Roche is creating DutaFabs, the next generation of bispecific antibodies intended for continuous administration through the Port administration implant with enhanced efficacy and durability.
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Graduated from the University of Kerala with B.Sc. Botany and Biotechnology. Attained Post-Graduation in Biotechnology from the Kerala University of Fisheries and Ocean Science (KUFOS) with the third rank. Conducted various seminars and attended major Science conferences. Done 6 months of internship in ICMR – National Institute of Nutrition, Hyderabad. 5 years of tutoring experience.
