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VABYSMO® (faricimab injection) Now Publicly Funded For Macular Edema Secondary to Retinal Vein Occlusion (RVO) and Pre-Filled Syringe (PFS) in Quebec Français
VABYSMO® (faricimab injection) Now Publicly Funded For Macular Edema Secondary to Retinal Vein Occlusion (RVO) and Pre-Filled Syringe (PFS) in Quebec Français

Cision Canada

time5 days ago

  • Business
  • Cision Canada

VABYSMO® (faricimab injection) Now Publicly Funded For Macular Edema Secondary to Retinal Vein Occlusion (RVO) and Pre-Filled Syringe (PFS) in Quebec Français

Vabysmo now covered across all three approved indications in the province, providing patients with a comprehensively funded option for their needs MISSISSAUGA, ON, Aug. 15, 2025 /CNW/ - Hoffmann-La Roche Limited (Roche Canada) is pleased to announce today that VABYSMO ® (faricimab injection) is now publicly funded for macular edema secondary to retinal vein occlusion (RVO) on the Régie de l'assurance maladie du Québec (RAMQ) list of medications. 1 This latest update also includes funding for Vabysmo in a 6.0 mg single-use pre-filled syringe (PFS), providing an additional option and expanded access for patients in Quebec. Vabysmo received Health Canada authorization for treatment of macular edema secondary to retinal vein occlusion (RVO) in July 2024, and the approval of the PFS format in December 2024. 2 "This expansion in coverage for people with RVO in Quebec is welcome news in our mission to advance eye care and provide innovative solutions for people living with serious retinal conditions," said Carlene Todd, Vice President, Access at Roche Pharmaceuticals Canada. "We are deeply committed to ensuring equitable and timely access to our treatments, ensuring that provinces across the country prioritize access to innovative medicines that will ultimately improve the lives of people impacted by vision loss." With this latest listing, Vabysmo is now covered in Quebec for all three of its indications and in both formats, including neovascular (wet) age-related macular degeneration (nAMD), diabetic macular edema (DME), and the latest, macular edema secondary to retinal vein occlusion (RVO). These leading causes of vision loss affect around 70 million people worldwide and can have a serious impact on patients, their families, and caregivers. 3,4,5,6 "The recent reimbursement for RVO in Quebec is a significant step forward for people living with the condition," said Dr. Ananda (Andy) Kalevar, Associate Professor, Department of Ophthalmology at Sherbrooke University, Quebec. "It gives ophthalmologists a valuable treatment option and provides patients with access to a medication that may ultimately offer the best outcomes for their vision." Roche Canada is committed to continuing to work with remaining provincial jurisdictions to make Vabysmo available through public and private drug plans for those living with RVO. About retinal vein occlusion (RVO) RVO is the second most common cause of vision loss due to retinal vascular conditions. It affects an estimated 28 million adults globally, mainly those aged 60 or older, and can lead to severe and sudden vision loss. 3,7 There are two main types of RVO: branch RVO (BRVO), which affects more than 23 million people globally and occurs when one of the four smaller 'branches' of the main central retinal vein becomes blocked; and central RVO (CRVO), which is less common, affecting more than four million people worldwide, and occurs when the eye's central retinal vein becomes blocked. 3,8 The levels of Vascular Endothelial Growth Factor A (VEGF-A) and angiopoietin-2 (Ang-2) are elevated in RVO and it is thought that their increased expression drives disease progression. 9,10 RVO typically results in sudden, painless vision loss in the affected eye because the vein blockage restricts normal blood flow in the affected retina, resulting in ischemia, bleeding, fluid leakage and retinal swelling called macular edema. 7,11,8 The safety and efficacy of Vabysmo for the treatment of macular edema secondary to retinal vein occlusion (RVO) were assessed in two randomised, multi-centre, double-masked, studies in patients with macular edema secondary to BRVO (BALATON) or CRVO/hemiretinal vein occlusion (HRVO) (COMINO). Between Week 24 and Week 72, for patients who received faricimab Q4W/faricimab PTI, 49% of patients in BALATON and 34% of patients in COMINO completed at least one cycle of every 12 weeks (Q12W) and maintained ≥ Q12W dosing without an interval reduction below Q12W through Week 68; 32% of patients in BALATON and 24% of patients in COMINO completed 2 cycles of Q16W through Week 72. 2 About Vabysmo ® (faricimab injection) Vabysmo is a humanized bispecific immunoglobulin G1 (IgG1) antibody that acts through inhibition of both Ang-2 and vascular endothelial growth factor A (VEGF-A). By inhibiting VEGF-A, faricimab suppresses endothelial cell proliferation, neovascularization and vascular permeability. By inhibiting Ang-2, faricimab is thought to increase vascular stability and desensitize blood vessels to the effects of VEGF-A. Ang-2 levels are increased in some patients with wet AMD, DME, and RVO. 2 In Canada, Vabysmo is authorized for the treatment of neovascular (wet) age-related macular degeneration (nAMD), diabetic macular edema (DME), and macular edema secondary to retinal vein occlusion (RVO). 2 To date, Vabysmo is approved in more than 100 countries for DME and nAMD, and in over 30 countries for macular edema following retinal vein occlusion (RVO). 12,13,14,15,16,17 About Roche Canada At Roche Canada, patients and science are at the heart of everything we do. Our passion for science and our commitment to relentlessly pursuing the impossible for patients have made us one of the world's leading pharmaceutical, in-vitro diagnostics, and diabetes care management companies. With our combined strength in diagnostics and pharmaceuticals, we're driving healthcare forward, while ensuring we deliver meaningful benefits for patients and sustainable healthcare systems. We are committed to creating a world where we all have more time with the people we love. And we're adding our expertise in new areas, such as artificial intelligence, real world data collection and analysis and collaborating with many different sectors and industries. Having the courage to reinvent ourselves and question the status quo is what patients and healthcare systems expect from Roche - and our commitment is as strong today as it was on the first day of our Canadian journey in 1931. Today, Roche Canada employs nearly 2,000 people at its offices in Mississauga, Ontario, in Laval, Quebec, and across the country from coast to coast to coast. For more information, please visit or follow Roche Canada on LinkedIn. References [1] RAMQ List of medications. Available at: Accessed on August 14, 2025. [2] Vabysmo Product Monograph, July 25, 2025 [3] Song P, et al. Global epidemiology of retinal vein occlusion: a systematic review and meta-analysis of prevalence, incidence, and risk factors. J Glob Health. 2019; 9:010427. Song P, et al. Global epidemiology of retinal vein occlusion: a systematic review and meta-analysis of prevalence, incidence, and risk factors. J Glob Health. 2019; 9:010427. [4] Yau JWY, et al. Global prevalence and major risk factors of diabetic retinopathy. Diabetes Care. 2012; 35:556–64. [5] Connolly E, et al. Prevalence of age-related macular degeneration associated genetic risk factors and 4-year progression data in the Irish population. Br J Ophthalmol. 2018;102:1691–95. [6] Bright Focus Foundation. Age-Related Macular Degeneration: Facts & Figures [Internet; cited August 2025]. Available from: Accessed on August 6, 2025. [7] Moorfields Eye Hospital, United Kingdom National Health Service Foundation Trust. RVO [Internet; cited August 2025]. Available from: Accessed on August 6, 2025. [8] Campochiaro P. Molecular pathogenesis of retinal and choroidal vascular diseases. Prog Retin Eye Res. 2015; 49:67-81. [9] Joussen et al. Angiopoietin/Tie2 signalling and its role in retinal and choroidal vascular diseases: a review of preclinical data. Eye. 2021; 35:1305-1316. [10] Regula JT, et al. Targeting key angiogenic pathways with a bispecific CrossMab optimised for neovascular eye diseases. EMBO Molecular Medicine. 2016; 8:1265–88. [11] Schmidt-Erfurth U, et al. Guidelines for the management of retinal vein occlusion by the European society of retina specialists (EURETINA). Ophthalmologica. 2019; 242:123-162. [12] U.S. Food and Drug Administration (FDA). Highlights of prescribing information, aflibercept 2 mg. 2022. [Internet; cited August 2025]. Available from: Accessed on August 6, 2025. [13] FDA. Highlights of prescribing information, Vabysmo. 2022. [Internet; cited August 2025]. Available from: Accessed on August 6, 2025. [14] FDA approves Genentech's Vabysmo for the treatment of RVO [Internet; cited August 2025]. Available from: Accessed on August 6, 2025 [15] Chugai obtains regulatory approval for Vabysmo, the only bispecific antibody in the ophthalmology field, for additional indication of macular edema associated with RVO. [Internet; cited August 2025]. Available from: Accessed on August 6, 2025. [16] European Medicines Agency. Summary of product characteristics, Vabysmo, 2022 [Internet; cited August 2025]. Available from: Accessed on August 6, 2025. [17] Roche Data on File SOURCE Hoffmann-La Roche Limited (Roche Canada)

Will These 5 Pharma/Biotech Bigwigs Surpass Q2 Earnings Forecasts?
Will These 5 Pharma/Biotech Bigwigs Surpass Q2 Earnings Forecasts?

Yahoo

time28-07-2025

  • Business
  • Yahoo

Will These 5 Pharma/Biotech Bigwigs Surpass Q2 Earnings Forecasts?

The second-quarter 2025 reporting cycle for the Medical sector is about to pick up pace this week, as most firms are slated to share their earnings results over the next two weeks. The sector mainly comprises pharma/biotech and medical device companies. The earnings season for the drug and biotech sector kicked off around mid-July when bellwether Johnson & Johnson reported strong second-quarter results, beating estimates for earnings and sales. J&J consequently raised its total revenue expectation as well as its adjusted earnings expectation for the year. Among other pharma bigwigs, Novartis beat second-quarter earnings and revenue estimates, driven by a year-over-year increase in sales of key drugs. Based on strong momentum, Novartis raised its annual guidance for core operating income. Roche also posted solid growth in the first half of 2025 as high demand for key drugs like Phesgo (breast cancer), Xolair (food allergies), Hemlibra (hemophilia A), Vabysmo (severe eye diseases) and Ocrevus (multiple sclerosis) offset the decline in sales of legacy drugs. Per the Earnings Trends report, as of July 23, 15% of the companies in the Medical sector — representing 27.2% of the sector's market capitalization — reported quarterly earnings. Of these, 88.9% outperformed earnings estimates, while 100% beat the same for revenues. Earnings increased 0.4% year over year, while revenues increased 10.2%. Overall, second-quarter earnings of the Medical sector are expected to increase 0.9%, while sales are expected to rise 7.9% from the year-ago quarter. Merck MRK, AstraZeneca AZN, Bristol Myers BMY, AbbVie ABBV and Moderna MRNA are all slated to release theirquarterly results this week. Let us see how these biotech/pharma companies are likely to have performed in the soon-to-be-reported quarter. Merck Merck has an encouraging earnings track record. It beat earnings estimates in each of the last four quarters, delivering an average earnings surprise of 3.82%. In the last reported quarter, MRK beat earnings estimates by 3.26%. Per our proven model, companies with the combination of a positive Earnings ESP and a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold) have a good chance of delivering an earnings beat. You can uncover the best stocks to buy or sell before they're reported with our Earnings ESP Filter. Merck has an Earnings ESP of -0.18% and a Zacks Rank #3 at present. The Zacks Consensus Estimate for MRK's earnings is pegged at $2.01 per share. You can see the complete list of today's Zacks #1 Rank stocks here. Merck's top-line growth in the second quarter is likely to have been driven by higher sales of its blockbuster cancer drug Keytruda, attributable to additional indications and patient demand. Merck is scheduled to release its quarterly earnings results before the opening bell on July 29. Merck & Co., Inc. Price and Consensus Merck & Co., Inc. price-consensus-chart | Merck & Co., Inc. Quote AstraZeneca AstraZeneca has a mixed earnings track recordover the trailing four quarters. The company's earnings beat estimates in three of the last four quarters, missing the mark on one occasion. On average, AZN registered an earnings surprise of 4.24% in the last four quarters. In the last reported quarter, AstraZeneca beat earnings estimates by 12.73%. AstraZeneca has an Earnings ESP of -0.64% and a Zacks Rank #3 at present. The Zacks Consensus Estimate for AZN's earnings is pegged at $1.09 per share. Sales of AstraZeneca's key medicines, mainly cancer drugs — Lynparza, Tagrisso and Imfinzi — and diabetes medicine Farxiga, are expected to have driven the company's top line in the second quarter, backed by strong demand trends. AstraZeneca is scheduled to release its quarterly earnings results before the opening bell on July 29. AstraZeneca PLC Price and Consensus AstraZeneca PLC price-consensus-chart | AstraZeneca PLC Quote Bristol Myers Bristol Myers has an excellent earnings track record. BMY's earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 20.16%. In the last reported quarter, Bristol Myers' earnings surpassed estimates by 19.21%. Bristol Myers has an Earnings ESP of -7.92% and a Zacks Rank #3 at present. The Zacks Consensus Estimate for BMY's earnings is pegged at $1.18 per share. Bristol Myers' revenues in the second quarter of 2025 are likely to have been impacted by a decline in sales from its legacy drugs, which include Eliquis, Revlimid, Pomalyst, Sprycel and Abraxane, among others. However, the expected decline is likely to have been partially offset by an increase in the sales of BMY's growth products like Opdivo, Yervoy, Reblozyl, Breyanzi, Zeposia, Opdualag and others. Bristol Myers is slated to release its quarterly earnings results before the opening bell on July 31. Bristol Myers Squibb Company Price and Consensus Bristol Myers Squibb Company price-consensus-chart | Bristol Myers Squibb Company Quote AbbVie AbbVie has an impeccable earnings track record to date. ABBV's earnings beat estimates in each of the trailing four quarters, delivering an average earnings surprise of 2.55%. In the last reported quarter, AbbVie's earnings beat estimates by 2.93%. AbbVie has an Earnings ESP of 0.00% and a Zacks Rank #3 at present. The Zacks Consensus Estimate for ABBV's earnings is pegged at $2.89 per share. AbbVie's top line is expected to have been driven by robust sales of key drugs Rinvoq, Skyrizi, Venclexta and Vraylar, coupled with significant contributions from newer drugs, namely Ubrelvy, Elahere, Epkinly and Qulipta. ABBV is scheduled to report its quarterly earnings results on July 31, before the opening bell. AbbVie Inc. Price and Consensus AbbVie Inc. price-consensus-chart | AbbVie Inc. Quote Moderna Moderna has an excellent earnings track record. It beat earnings estimates in each of the last four quarters, delivering an average earnings surprise of 31.60%. In the last reported quarter, MRNA beat earnings estimates by 13.70%. Moderna has an Earnings ESP of +7.22% and a Zacks Rank #3 at present, indicating a positive surprise this time around. The Zacks Consensus Estimate for MRNA's loss per share is pegged at $2.99. Moderna's second-quarter revenues are expected to have been driven by sales of its COVID-19 vaccine, Spikevax. However, with declining demand for COVID-related products, investors are advised to focus more on updates regarding the company's broader pipeline. Moderna is slated to release its quarterly earnings results before the opening bell on Aug. 1. Moderna, Inc. Price and Consensus Moderna, Inc. price-consensus-chart | Moderna, Inc. Quote 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 AstraZeneca PLC (AZN) : Free Stock Analysis Report Bristol Myers Squibb Company (BMY) : Free Stock Analysis Report Merck & Co., Inc. (MRK) : Free Stock Analysis Report Moderna, Inc. (MRNA) : Free Stock Analysis Report AbbVie Inc. (ABBV) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research Sign in to access your portfolio

Regeneron Stock Plunges 22.6% YTD: Should You Buy, Sell or Hold?
Regeneron Stock Plunges 22.6% YTD: Should You Buy, Sell or Hold?

Globe and Mail

time18-07-2025

  • Business
  • Globe and Mail

Regeneron Stock Plunges 22.6% YTD: Should You Buy, Sell or Hold?

Shares of Regeneron Pharmaceuticals, Inc. REGN have lost 22.6% year to date against the industry 's growth of 0.6%. The stock has underperformed the medical sector and S&P 500 Index in this timeframe. A decline in lead drug Eylea sales has adversely impacted top-line growth. Regeneron Underperforms Industry, Sector and S&P 500 Image Source: Zacks Investment Research While the company is making efforts to diversify its revenue base and develop its oncology franchise, Eylea's dismal performance in an increasingly competitive environment has dampened investors' sentiment. Pipeline setbacks have also hurt the share price of late. Eylea's Sales Decline Hampers REGN Ophthalmology Unit Lead drug Eylea is an anti-vascular endothelial growth factor inhibitor approved for various ophthalmology indications. Eylea sales have boosted the company's top line for many years. However, Eylea's sales have been under pressure in the past couple of years due to competition from Roche 's RHHBY Vabysmo. The uptake of Roche's Vabysmo has been phenomenal. Roche has designed Vabysmo to block pathways involving Ang-2 and VEGF-A. Biosimilar competition for Eylea is also worrisome. Since Eylea accounts for a majority of REGN's sales, a rapid decline in sales has adversely impacted the company's top line. To counter the decline in Eylea sales, Regeneron has developed a higher dose of the drug. While the initial uptake of Eylea HD was encouraging as Eylea patients transitioned to the higher dose, it will take Eylea HD quite some time to offset the rapid erosion in Eylea sales. In April 2025, the FDA accepted for priority review a supplemental biologics license application (sBLA) seeking approval of Eylea HD for both the treatment of macular edema following retinal vein occlusion (RVO) and broadening the dosing schedule to include every 4-week (monthly) dosing across approved indications. The FDA has set a target action date of Aug. 19, 2025. However, the regulatory body issued a complete response letter ('CRL') for the pre-filled syringe of Eylea HD. Per the company, the key outstanding issue relates to a question posed by the FDA to a third-party component supplier. This component supplier has expeditiously responded to FDA requests for information. The FDA also issued a CRL regarding the sBLA for the addition of extended dosing intervals. The FDA indicated that the submitted data did not support extended dosing intervals greater than every 16 weeks. Regeneron has a collaboration agreement with Bayer BAYRY for Eylea. Regeneron records the net product sales of Eylea and Eylea HD in the United States, and Bayer records its net product sales outside the country. Regeneron records its share of profits in connection with Eylea's sales outside the United States. Dupixent Boosts REGN's Top Line REGN's top line also comprises its share of profits/losses in connection with the global sales of Dupixent. Partner Sanofi SNY records global net product sales of Dupixent. Solid sales of Dupixent (approved for use in certain patients with atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis and eosinophilic esophagitis) have fueled the top line for Sanofi and Regeneron. SNY and REGN are working to expand the drug's label further. The FDA had earlier approved Dupixent for chronic obstructive pulmonary disease (COPD). The approved indication is an add-on maintenance treatment for adults with inadequately controlled COPD and an eosinophilic phenotype. In April 2025, Dupixent's label was further expanded for the treatment of adults and adolescents aged 12 years and older with chronic spontaneous urticaria who remain symptomatic despite antihistamine treatment. The FDA recently approved Dupixent for the treatment of adult patients with bullous pemphigoid. Strong demand trends and consistent label expansion should fuel Dupixent sales. REGN's Focus on Oncology The company also has other arrows in its quiver. It is looking to strengthen its oncology franchise, which comprises Libtayo (cemiplimab-rwlc), indicated in certain patients with advanced basal cell carcinoma, advanced cutaneous squamous cell carcinoma and advanced non-small cell lung cancer. REGN's oncology franchise received a boost with the EC's approval of odronextamab for treating adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) or R/R diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. The drug has been approved under the brand name Ordspono. However, the company's efforts to get odronextamab approved in the United States suffered a setback. The regulatory body issued CRLs for its biologics license application (BLA) for odronextamab in March 2024. The FDA accepted for review the resubmission of the BLA for odronextamab with a target action date of July 30, 2025. Regeneron recently obtained FDA approval of linvoseltamab-gcpt for the treatment of R/R multiple myeloma (MM). The regulatory body granted accelerated approval to linvoseltamab under the brand name Lynozyfic. Lynozyfic is also approved in the European Union to treat adults with R/R MM after at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody. The successful development of these oncology drugs should be a great boost for REGN. REGN Looking to Build an Obesity Franchise Regeneron is looking to make inroads in the lucrative obesity market. The company recently entered into an in-licensing agreement for an obesity drug with Hansoh Pharmaceuticals Group Company Limited, in a bid to expand its clinical-stage obesity portfolio. The licensing agreement with Hansoh Pharma provides Regeneron with HS-20094, a GLP-1/GIP receptor agonist. Regeneron will acquire exclusive clinical development and commercial rights for HS-20094, a dual GLP-1/GIP receptor agonist, outside the Chinese Mainland, Hong Kong and Macau. The in-licensing agreement for an obesity candidate will expand REGN's obesity pipeline, which includes trevogrumab. The successful development of any obesity treatment will be a great boost for the company. REGN: Valuation & Estimates Going by the price/earnings ratio, REGN is expensive at this moment. Shares currently trade at 18.27X forward earnings, slightly lower than its mean of 18.85X but higher than the large-cap pharma industry's value of 15.04X. The bottom-line estimate for 2025 has dropped 57 cents to $36.15 over the past 60 days and the same for 2026 has decreased $1.49. Final Thoughts on Regeneron Large biotech companies are considered safe havens for investors interested in this sector. However, Regeneron is sailing in troubled waters as of now and has a tough road ahead, as it will take a long time for Eylea HD to replace Eylea sales. The stock got hammered at the end of May after REGN and partner Sanofi reported mixed results from two late-stage studies, AERIFY-1 and AERIFY-2, on itepekimab for the treatment of chronic obstructive pulmonary disease. While the AERIFY-1 study met the primary endpoint, AERIFY-2 did not meet the same. We believe that the near-term pipeline setbacks and challenges with Eylea weigh on the stock for now. We would advise prospective investors to be on the sidelines for the time being. For investors already owning the stock, selling it at current levels would be prudent. REGN currently carries a Zacks Rank #4 (Sell). You can see . 5 Stocks Set to Double Each was handpicked by a Zacks expert as the favorite stock to gain +100% or more in the months ahead. They include Stock #1: A Disruptive Force with Notable Growth and Resilience Stock #2: Bullish Signs Signaling to Buy the Dip Stock #3: One of the Most Compelling Investments in the Market Stock #4: Leader In a Red-Hot Industry Poised for Growth Stock #5: Modern Omni-Channel Platform Coiled to Spring Most of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor. While not all picks can be winners, previous recommendations have soared +171%, +209% and +232%. Download Atomic Opportunity: Nuclear Energy's Comeback free today. 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 Sanofi (SNY): Free Stock Analysis Report Bayer Aktiengesellschaft (BAYRY): Free Stock Analysis Report

Biologic Competition, Payer Pressures, and Gene Therapy Momentum Define a Pivotal Moment in nAMD and DME Management, According to Spherix Global Insights
Biologic Competition, Payer Pressures, and Gene Therapy Momentum Define a Pivotal Moment in nAMD and DME Management, According to Spherix Global Insights

Yahoo

time10-07-2025

  • Health
  • Yahoo

Biologic Competition, Payer Pressures, and Gene Therapy Momentum Define a Pivotal Moment in nAMD and DME Management, According to Spherix Global Insights

More than 70% of surveyed U.S. ophthalmologists anticipate a fundamentally transformed approach to managing nAMD and DME within the next five years. Exton, Pennsylvania, July 10, 2025 (GLOBE NEWSWIRE) -- Recently released research from Spherix Global Insights provides a timely look at the increasingly competitive and complex treatment landscape for neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME). The Q2 wave of the syndicated RealTime Dynamix™ studies—based on responses from more than 100 U.S. ophthalmologists, primarily retina specialists—captures current prescribing dynamics, perceptions of leading therapies, and evolving expectations shaped by emerging treatments and payer influence. Study findings reveal Roche/Genentech's Vabysmo continues to command the lead in the retina market, earning strong marks for efficacy, physician satisfaction, and flexible dosing. Regeneron's Eylea HD is steadily gaining ground as retina specialists sharpen their focus on newer, longer-acting options. At the same time, Eylea 2mg remains the preferred second line product, after Avastin, due to its long-term data, efficacy, and safety profile. Despite high awareness, biosimilars remain on the periphery—particularly in the first-line setting. While many physicians are open to their use in principle, uptake remains modest, constrained in part by clinical conservatism and concerns about interchangeability. However, many ophthalmologists acknowledge that the payer environment could force a shift, especially if step therapy mandates begin to require biosimilar trials before branded biologic access. Payer influence continues to cast a long shadow over treatment decisions, with roughly three-quarters of respondents reporting that coverage restrictions, prior authorization requirements, and cost-sharing concerns regularly impact prescribing choices. Physicians estimate that one in three patients with nAMD or DME are likely receiving less-than-optimal care due to these access-related hurdles. Most practices now rely on dedicated biologic coordinators to manage the administrative load, but even with support staff in place, prior authorizations remain a major friction point. The increasing use of AI-driven auto-denial systems is only exacerbating these delays, introducing new workflow inefficiencies, and stalling the initiation of preferred therapies. Amid this increasingly complicated environment, gene therapies are offering a sense of future promise. Ophthalmologists are optimistic about the long-term potential of assets in development such as 4DMT's 4D-150, AbbVie's ABBV-RGX-314, and Adverum's Ixo-vec. These agents are generating significant anticipation for their ability to reduce treatment burden and deliver transformative durability, potentially redefining the landscape beyond traditional biologics. Indeed, as the in-line competitive field tightens and new options on the horizon expand, over 70% of ophthalmologists expect a fundamentally reshaped treatment landscape within the next five years. The latest Q2 update of the RealTime Dynamix™ series include responses from 112 U.S. ophthalmologists (101 for nAMD; 100 for DME) with high-volume patient caseloads. Data were collected between May 5 and June 11, 2025. As the market continues to shift under the pressure of payer dynamics and pipeline disruption, Spherix will continue to track these developments and deliver actionable insights to keep stakeholders ahead of the curve. RealTime Dynamix™ is an independent service providing strategic guidance through quarterly or semiannual reports, which include market trending and a fresh infusion of event-driven and variable content with each wave. The reports provide an unbiased view of the competitive landscape within rapidly evolving specialty markets, fueled by robust HCP primary research and our in-house team of experts. About Spherix Global Insights Spherix is a leading independent market intelligence and advisory firm that delivers commercial value to the global life sciences industry, across the brand lifecycle. The seasoned team of Spherix experts provides an unbiased and holistic view of the landscape within rapidly evolving specialty markets, including dermatology, gastroenterology, rheumatology, nephrology, neurology, ophthalmology, and hematology. Spherix clients stay ahead of the curve with the perspective of the extensive Spherix Physician Community. As a trusted advisor and industry thought leader, Spherix's unparalleled market insights and advisory services empower clients to make better decisions and unlock opportunities for growth. To learn more about Spherix Global Insights, visit or connect through LinkedIn. For more details on Spherix's primary market research reports and interactive dashboard offerings, visit or register here: NOTICE: All company, brand or product names in this press release are trademarks of their respective holders. The findings and analysis addressed within are based on Spherix Global Insight's analysis and do not imply a relationship with or endorsement of the companies or brands mentioned in this press release. CONTACT: Bob Shewbrooks, Ophthalmology Franchise Head Spherix Global Insights 4848794284

Attitude to eye health criticised
Attitude to eye health criticised

Otago Daily Times

time10-06-2025

  • Health
  • Otago Daily Times

Attitude to eye health criticised

A multinational pharmaceutical company has stooped to "punching down" on New Zealand's disabled community while promoting its vision loss treatment, a Dunedin advocate says. Market research by the New Zealand arm of Roche, a Swiss multinational holding healthcare company, was released last week and said while most people understood the importance of vision, public awareness of specific eye conditions, symptoms and how to prevent vision loss remained low. "New Zealanders overwhelmingly value their vision above all other senses according to recent market research, with participants saying they'd be willing to lose 5.6 years of perfect health, rather than live a decade without sight," the company's media release began. In New Zealand, Roche distributes Vabysmo, a medicine approved by MedSafe to treat age-related macular degeneration, the leading cause of blindness in the country. Blind and low vision advocate and Dunedin resident Julie Woods, who is also known as "That Blind Woman", said it "distresses" her the company was comparing hypothetical trade-offs between life expectancy and vision loss. "That just shows how afraid people are of vision loss," she said. "You can live a perfectly good life without vision, but you can't without your health." She said preserving eye health was "obviously" a great cause. "But it doesn't give organisations the right to push their own product and put down [or punch] down a community of people." Ms Woods said Roche's approach spoke to a medical model of disability which was: "we can't fix you, therefore you're broken". "Whereas the social model of disability says that we are disabled by the barriers that society creates, and we're not broken and we're not less than." She said Roche's use of New Zealanders' fears of not seeing loved ones' faces or recognising facial expressions, body language and social cues was "bull...." and was emotive toward sighted people. A Roche spokesperson said the market research was based on a similar study conducted in the United Kingdom and the company sought guidance from professionals within the eye community, including a patient advocacy group. "Their advice advocated for raising awareness about the importance of eye health and regular eye examinations to prevent irreversible, yet preventable, vision loss," the spokesperson said. "The intent of the campaign was to raise awareness of the importance of eye health and preventable vision loss, encouraging individuals to get their eyes tested or seek help if they are experiencing symptoms." The spokesperson said Roche respected Ms Woods' opinion and acknowledged her advocacy for the blind and low vision community in New Zealand.

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