Roche Gets FDA Nod for Label Expansion of Susvimo for Third Indication

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.Image Source: Zacks Investment ResearchMore on RHHBY’s SusvimoThe 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 PortfolioThe 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.Consequently, Regeneron’s top line has been under pressure due to a decline in Eylea sales. Regeneron has a tough road ahead, as it will take a long time for Eylea HD to contribute significantly to the top line.Roche’s performance in the first quarter of 2025 was good, as high demand for key drugs offset the decline in sales of legacy drugs.RHHBY's Zacks Rank and Key PicksRoche currently carries a Zacks Rank #3 (Hold). A couple of better-ranked large-cap pharma stocks are Novartis NVS and Pfizer PFE, both carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.The Zacks Consensus Estimate Novartis’ 2025 earnings per share (EPS) has risen from $8.47 to $8.74 over the past 60 days. EPS estimates for 2026 have jumped 20 cents to $9.02 during this timeframe.  The stock has risen 18.3% so far this year.Pfizer’s 2025 EPS estimate has risen from $2.99 to $3.08 in the past 60 days, while that for 2026 has gone up from $2.99 to $3.09 during the same timeframe. 7 Best Stocks for the Next 30 DaysJust released: Experts distill 7 elite stocks from the current list of 220 Zacks Rank #1 Strong Buys. They deem these tickers "Most Likely for Early Price Pops."Since 1988, the full list has beaten the market more than 2X over with an average gain of +23.0% per year. So be sure to give these hand picked 7 your immediate attention. See them now >>Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Regeneron Pharmaceuticals, Inc. (REGN): Free Stock Analysis Report Novartis AG (NVS): Free Stock Analysis Report Roche Holding AG (RHHBY): Free Stock Analysis Report Pfizer Inc. (PFE): Free Stock Analysis ReportThis article originally published on Zacks Investment Research (zacks.com).Zacks Investment ResearchWeiter zum vollständigen Artikel bei Zacks Weiter zum vollständigen Artikel bei Zacks