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Roche RHHBY announced today that the FDA has approved a label expansion of ophthalmology drug Susvimo (ranibizumab injection).
The regulatory body approved the drug Susvimo for the treatment of diabetic retinopathy (DR). This is the third indication for which the drug has received FDA approval.
Susvimo can help DR patients maintain their vision and prevent progression to blindness with only one treatment every nine months.
Year to date, shares of Roche have risen 14.4% against the industry’s 4% decline.
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More on RHHBY’s Susvimo
The FDA approval was based on positive one-year results from the phase III Pavilion study, which showed that people suffering from DR who received Susvimo refilled every nine months achieved superior improvements on the Diabetic Retinopathy Severity Scale.
These patients experienced a reduction in the severity of eye damage caused by diabetes compared with those under monthly clinical observation who were treated with anti-vascular endothelial growth factor (VEGF) injections as needed based on disease progression. None of the participants receiving Susvimo required supplemental treatment at one year.
Susvimo is a refillable eye implant surgically inserted into the eye during a one-time, outpatient procedure. It provides continuous delivery of a customized formulation of ranibizumab via the Port Delivery Platform, while other currently approved treatments require eye injections as often as once per month.
Ranibizumab is a VEGF inhibitor designed to bind to and inhibit VEGF-A, a protein that has been shown to play a critical role in the formation of new blood vessels and the leakiness of the vessels.
Susvimo is also approved for neovascular or ‘wet’ age-related macular degeneration (nAMD) and diabetic macular edema (DME).
Per Roche, the customized formulation of ranibizumab delivered by Susvimo is different from the ranibizumab intravitreal injection, which is marketed as Lucentis.
Lucentis is also approved to treat nAMD and other retinal diseases. However, Lucentis is facing generic competition.
New Drug Approvals Strengthen Roche’s Portfolio
The label expansion of Susvimo strengthens RHHBY’s ophthalmology portfolio, which includes Vabysmo (faricimab).
Vabysmo is the first bispecific antibody approved for the eye, which targets and inhibits two signaling pathways linked to a number of vision-threatening retinal conditions by neutralising angiopoietin-2 and VEGF-A.
Vabysmo is approved for nAMD, DME and macular edema following retinal vein occlusion. Its uptake has been outstanding and has taken away market share from Regeneron’s REGN blockbuster drug Eylea.