Bevacizumab

Seven months after the FDA approved the reintroduction of Roche's eye implant Susvimo, the US agency has expanded its approved use to include treatment for diabetic macular edema, the primary cause of blindness related to diabetes. This marks the second approved indication for Susvimo, which was initially cleared in October 2021 as an alternative to frequent eye injections for wet age-related macular degeneration. LAS VEGAS, April 30, 2025 /PRNewswire/ -- Diabetic macular edema is a complication that develops from diabetic retinopathy, a widespread consequence of diabetes and a leading cause of irreversible vision loss in working-age adults globally. Diabetic retinopathy occurs due to long-term damage to the retina's small blood vessels, leading to fluid leakage and swelling—especially in the macula. As per DelveInsight's analysis, there were about 1.9 million prevalent cases of DME across the 7MM in 2023, with numbers expected to grow at a notable CAGR during the forecast period. The primary treatment for DME includes intravitreal injections, where the eye is numbed with drops before injecting medication directly into the vitreous humor. Common anti-VEGF drugs used include AVASTIN, EYLEA, and LUCENTIS. Additionally, corticosteroids are beneficial in cases of DME linked to inflammatory eye conditions and can be delivered via eye drops, oral tablets, or periocular injections to help reduce inflammation. The US FDA approved sustained-release corticosteroid implants for more serious or longer-lasting conditions, are OZURDEX, RETISERT, and ILUVIEN. Learn more about the diabetic macular edema treatment @ New Treatment for Diabetic Macular Edema EYLEA (Regeneron Pharmaceuticals) – Aflibercept is a recombinant fusion protein composed of the VEGF-binding regions derived from the extracellular domains of human VEGF receptors 1 and 2, linked to the Fc segment of human IgG1. It functions as a VEGF trap by binding to circulating vascular endothelial growth factors (VEGFs), thereby neutralizing VEGF-A, VEGF-B, and placental growth factor (PGF). This action inhibits the formation of new blood vessels in the tumor's choriocapillaris. In July 2014, the U.S. FDA approved EYLEA (aflibercept) Injection for treating diabetic macular edema (DME). Ranibizumab (Genentech) – Marketed as LUCENTIS, ranibizumab is a monoclonal antibody fragment (Fab) derived from the same original mouse antibody as bevacizumab. It is an anti-angiogenic therapy used to treat the "wet" form of age-related macular degeneration (AMD), a leading cause of vision loss in older adults. Ranibizumab has shown comparable effectiveness to bevacizumab. Developed by Genentech, it is marketed in the U.S. by Genentech and internationally by Novartis. The FDA approved ranibizumab for the treatment of DME in 2012. In February 2025, Roche announced that the FDA had approved Susvimo (ranibizumab injection) 100 mg/mL for treating diabetic macular edema (DME), a major cause of vision loss in adults with diabetes. This approval is based on positive one-year data from the phase III Pagoda trial, which demonstrated that Susvimo offered sustained improvements in vision for individuals with DME, with a safety profile consistent with what is already known for the drug. In the study, patients receiving Susvimo refills every six months experienced vision gains comparable to those receiving monthly intravitreal injections of 0.5 mg ranibizumab (9.6 letters versus 9.4 letters on an eye chart, equivalent to about two lines of vision improvement). Susvimo delivers a specially formulated version of ranibizumab continuously through the Port Delivery Platform, offering a less frequent dosing alternative compared to other treatments that may require monthly eye injections. The FDA initially approved Susvimo in 2021 for the treatment of neovascular age-related macular degeneration (nAMD). Regulatory reviews in other countries are currently underway. Learn more about the FDA-approved DME drugs @ Drugs for Diabetic Macular Edema Treatment Key players, such as Oculis, Rezolute, AsclepiX Therapeutics, and others, are evaluating their lead candidates in different stages of clinical development, respectively. They aim to investigate their products for the treatment of diabetic macular edema. The DME market has a promising outlook with the emerging therapies. Some of the drugs in the pipeline are OCS-01, RZ402, AXT107, and others. DME leads to significant vision loss in diabetics, affecting up to 7.9% of type 1 and 12.8% of type 2 diabetes patients. AbbVie, in collaboration with REGENEXBIO, is developing the gene therapy ABBV-RGX-314. This therapy targets wet age-related macular degeneration, diabetic retinopathy (DR), and other chronic retinal diseases, potentially offering a breakthrough in treating these conditions. Discover which therapies are expected to grab major DME market share @ Diabetic Macular Edema Market Report OCS-01 is a high-concentration dexamethasone eye drop developed for diabetic macular edema (DME), utilizing the proprietary Optireach solubilizing platform. This technology enhances drug solubility, allows for higher concentrations, prolongs ocular retention, and improves bioavailability in eye tissues, including the retina. Recently, in April 2025, Oculis announced the completion of patient enrollment for its Phase 3 DIAMOND-1 and DIAMOND-2 clinical trials evaluating OCS-01 eye drops for diabetic macular edema (DME). These pivotal registration studies aim to support global regulatory filings, including a New Drug Application (NDA) submission and potential approval by the U.S. FDA. Over 800 patients were enrolled across 119 sites in the U.S. and other countries. The swift completion of enrollment in the DIAMOND program—comprising two double-masked, randomized, multi-center Phase 3 trials—is a significant milestone. These studies are assessing the efficacy and safety of OCS-01 over a 52-week treatment period in patients with DME. Topline results are anticipated in Q2 2026, followed by an NDA submission. If approved, OCS-01 would be the first topical eye drop treatment for DME, offering a novel therapeutic option for early intervention and for patients who do not adequately respond to anti-VEGF therapies. RZ402 is an oral small-molecule drug that selectively inhibits plasma kallikrein (PK) for the long-term treatment of DME. By blocking kallikrein activation, RZ402 aims to prevent bradykinin-driven vascular leakage and inflammation. Phase II results revealed a significant reduction in central subfield thickness (CST) across all dosing levels, with improvements of up to ~50 microns compared to placebo. The treatment was well tolerated and showed a favorable safety profile. AXT107 targets two validated mechanisms for treating retinal vascular diseases: it inhibits the pro-angiogenic receptor VEGFR2 and activates the vessel-stabilizing Tie2 receptor. These effects are mediated through its interaction with integrins αvβ3 and α5β1. AXT107 is formulated as a microparticulate suspension designed for intraocular injection and is currently undergoing Phase I/II clinical trials, according to the company's development pipeline. Discover more about drugs for DME in development @ Diabetic Macular Edema Clinical Trials The anticipated launch of these emerging therapies for DME are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the DME market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. DelveInsight estimates that the market size for DME is expected to grow from USD 3 billion in 2023, with a significant CAGR by 2034. Owing to the higher patient pool and higher diabetic macular edema treatment cost, according to the estimates, the United States had the highest market size in DME, i.e., ~60% of the total market size of DME in the 7MM, in 2023, followed by Germany and Japan. DelveInsight's analysis forecasts market growth due to the introduction of emerging therapies, expecting a rise in market size during the study period (2020–2034). The anticipated increase in market size is driven by advancements in treatment options, greater healthcare access, and a rising prevalence of the condition, which together foster higher demand for innovative and effective therapies. DelveInsight's latest published market report, titled as Diabetic Macular Edema Market Insight, Epidemiology, and Market Forecast – 2034 , will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the DME country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The DME market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total Prevalent Cases of DME Total Diagnosed Prevalent Cases of DME Gender-specific Diagnosed Prevalent Cases of DME Age-Specific Diagnosed Prevalent Cases of DME Subgroup-specific Diagnosed Prevalent Cases of DME The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM DME market. Highlights include: 10-year Forecast 7MM Analysis Epidemiology-based Market Forecasting Historical and Forecasted Market Analysis upto 2034 Emerging Drug Market Uptake Peak Sales Analysis Key Cross Competition Analysis Industry Expert's Opinion Access and Reimbursement Download this DME market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs' opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the DME market. Also, stay abreast of the mitigating factors to improve your market position in the DME therapeutic space. Related Reports Diabetic Macular Edema Epidemiology Forecast Diabetic Macular Edema Epidemiology Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted diabetic macular edema epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan. Diabetic Macular Edema Pipeline Diabetic Macular Edema Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key diabetic macular edema companies, including Mylan Pharmaceuticals, Kodiak Sciences, Celltrion, Exonate, Opthea, AsclepiX Therapeutics, Allgenesis Biotherapeutics, Ascentage Pharma, Rezolute, Ocuphire Pharma, Oxurion, MingSight Pharmaceuticals, Adverum Biotechnologies, among others. Diabetic Retinopathy Market Diabetic Retinopathy Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key diabetic retinopathy companies, including Genentech, Inc., Regeneron Pharmaceuticals, Roche, Opthea Limited, Regenxbio, Kodiak Sciences Inc, Ocuphire Pharma, Eisai Co Ltd, Apexian Pharmaceuticals, Oculis, among others. Diabetic Retinopathy Pipeline Diabetic Retinopathy Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key diabetic retinopathy companies, including Kodiak Sciences, Novartis, Regenxbio Inc., OcuTerra Therapeutics, Ocular Therapeutix, Bayer, RemeGen, Roche, Ocuphire Pharma, Adverum Biotechnologies, Boehringer Ingelheim, Palatin Technologies, Valo Health, EyePoint Pharmaceuticals, Kubota Vision, MingSight Pharmaceuticals, Oxurion, Aerie Pharmaceuticals, AsclepiX Therapeutics, Ocugen, Ashvattha Therapeutics, Stealth BioTherapeutics, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Regeneron’s higher-dose version of Eylea, Eylea HD, grew U.S. sales 54% in the first quarter to $307 million. Still, those gains weren’t enough to offset a significant sales decline for the original version of the drug. After consecutive setbacks at the FDA, Regeneron's string of recent troubles with its Eylea franchise is continuing to pull down the drugmaker.Over the first three months of 2025, Regeneron's sales from the Eylea franchise—approved in a range of retinal conditions like macular degeneration and diabetic retinopathy—fell 26% versus 2024’s first quarter, the company said in a Tuesday press release. Overall, the franchise generated $1.04 billion during the quarter.Digging into the numbers, standard Eylea’s U.S. sales dropped 39% in the first quarter to $736 million, missing Wall Street’s consensus sales estimate by nearly $100 million, analysts at Evercore ISI wrote in a note to clients Tuesday.Meanwhile, Regeneron’s newer and higher-dose version of the eye med, Eylea HD, grew U.S. sales 54% over the same period in 2024 to $307 million. Still, those gains weren’t enough to offset a significant sales decline for the franchise overall between January and March. On a conference call Tuesday, CEO Leonard Schleifer, M.D., Ph.D., was quick to admit that Regeneron’s performance in the first quarter was “mixed.”The New York drugmaker endured “some difficult news related to our retinal franchise,” which was otherwise “offset by encouraging news relating to the rest of our commercial portfolio,” Schleifer explained.Commenting on the Eylea franchise’s struggles in the quarter, the CEO noted that the overall size of the branded anti-VEGF category “contracted” during the first three months of the year. Schleifer attributed the shift to more patients using off-label bevacizumab—aka Avastin—to treat their retinal conditions, which is likely being driven by affordability issues linked to funding gaps at copay assistance foundations, he argued. Avastin, while mainly used to treat cancer, works similarly to Eylea by blocking the vascular endothelial growth factor (VEGF) protein, which plays a key role in the formation of blood vessels.Executives at Roche—which offers its own VEGF inhibitor, Vabysmo, that competes directly with Eylea in many indications—also commented on a branded VEGF market contraction in 2025’s first quarter during an earnings call last week, the Evercore analysts pointed out in their note.Roche's Vabysmo sales reached 1.02 billion Swiss francs ($1.2 billion) during the first quarter, an 18% increase worldwide.The other shoe drops While Regeneron remains confident that Eylea HD sales will continue to grow over time, copay problems and off-label Avastin use aren’t all there is to the saga of the VEGF franchise’s recent stumbles.Alongside the financial details on its first-quarter performance, Regeneron also revealed that the FDA last week rejected the company’s application for a prefilled syringe version of Eylea HD. Just days before that complete response letter, the FDA also rebuffed Regeneron’s bid to win extended dosing intervals for Eylea HD across all the med’s approved indications.Transitioning U.S. Eylea HD patients to a prefilled syringe—versus the current vial and needle format—forms a “critical component” in the product’s evolution and is “necessary to be competitive with Roche’s Vabysmo,” the Evercore analysts said in Tuesday’s note.Schleifer, for his part, expressed disappointment with the FDA's decision and sought to provide clarity on the situation following “several teleconferences” with the agency in the aftermath of last week’s rejection.The FDA’s issue appears to come down to a “third-party component supplier,” Schleifer said, referring to a contractor responsible for, at least in part, producing the prefilled syringe device itself.“Based on our conversations with the FDA, we believe that there’s one key issue that is left to resolve,” Schleifer said, without identifying the contractor by name. “There are a few other minor ones, which I think were just clarification, but the one key issue relates to a supplier, and the supplier has told us that the FDA asked for some data.”The supplier already had the data needed and turned the information over to the FDA posthaste following the rejection, Schleifer said.Eylea HD is already approved in the EU as a prefilled syringe using the same device, design and components that are included in Regeneron’s U.S. application, the Evercore team noted.Although Regeneron expects the Eylea HD prefilled syringe will eventually win approval in the U.S., Schleifer admitted that there remains “a little bit of uncertainty on how fast this could all get resolved.”The Evercore team noted that the prefilled syringe rejection represents the latest in a “laundry list of CRLs” that Regeneron’s Eylea HD has received since an initial FDA rebuff over third-party manufacturing issues in June 2023.Still, Schleifer was quick to defend his company, noting that he feels Regeneron’s regulatory and manufacturing teams are “first rate.”“The kinds of issues that have come up are reflecting, in my view, an increased scrutiny by the FDA—post-COVID—on contract manufacturers,” Schleifer said.“I think the FDA is trying to step up the game, if you will, of these contract manufacturers,” the CEO added. “And since we’re so active, we see more.”The long view Despite Eylea HD’s recent setbacks, Regeneron is far from throwing in the towel, with additional reviews currently underway at the FDA to attempt to push the medicine into macular edema following retinal vein occlusion and to secure a potential shift to monthly dosing.“While we expect competitive pressures for Eylea to persist, our focus remains on promoting the ongoing adoption of Eylea HD, which has the potential to become the new standard of care,” Regeneron’s executive vice president of commercial, Marion McCourt, said on the company’s conference call.“With these label enhancements and anticipated approval of the prefilled syringe, we expect to see an acceleration in Eylea HD demand,” McCourt said.Regeneron posted its Eylea updates as the company reported total first-quarter sales of $3 billion, a 4% decrease compared to the same period last year. As for the rest of Regeneron’s commercial medicine chest, cancer med Libtayo grew total sales—both in the U.S. and beyond—by 8% to $285 million for the quarter. Regeneron’s next highest-earning drug, cholesterol med Praluent, suffered a 19% sales decline to $57 million in the U.S.The company also shares sales on the immunology megablockbuster Dupixent with French drugmaker Sanofi. Last week, Sanofi reported first-quarter Dupixent sales of 3.5 billion euros (roughly $4 billion). Sanofi is anticipating that annual sales of Dupixent could reach a whopping $22 billion by the end of the decade. After Regeneron reported its first-quarter results, the company's share price dropped by about 6% on Tuesday afternoon.