Multifocal Electroretinography and contrast sensitivity outcomes with Treat-and-Extend versus Pro Re Nata Ranibizumab for Diabetic macular edema: A Randomized control trial - Nil

Start Date31 Dec 2025

Sponsor / Collaborator-

CTRI/2025/12/098727

/ RecruitingNot ApplicableIIT

Comparison of Systemic Inflammation and OCT-Based Biomarkers in Patients with Diabetic Macular Edema and Their Role in Predicting Treatment Outcomes After Ranibizumab Injection - NIL

Start Date23 Dec 2025

Sponsor / Collaborator-

NCT06847542

/ RecruitingPhase 3

A Phase IIIb, Multicenter, Single-arm Study Assessing the Effectiveness, Safety and Patient Reported Outcomes of a 36-week Refill Exchange Regimen for the Port Delivery System With Ranibizumab in Patients With Neovascular Age-related Macular Degeneration

The purpose of this study is to evaluate the effectiveness, safety, and PROs of the port delivery system with ranibizumab 100 milligrams/milliliters (mg/mL) refilled every 36 weeks (Q36W) in participants with nAMD.

Start Date27 Nov 2025

Sponsor / Collaborator

Hoffmann-La Roche Ltd.

[+1]

100 Clinical Results associated with Ranibizumab (Genentech)

100 Translational Medicine associated with Ranibizumab (Genentech)

100 Patents (Medical) associated with Ranibizumab (Genentech)

4,828

Literatures (Medical) associated with Ranibizumab (Genentech)

01 May 2026·Value in Health Regional Issues

Cost-Effectiveness of Vascular Endothelial Growth Factor Inhibitors in the Management of Wet Age-Related Macular Degeneration: A Systematic Review

Article

Author: Paneerselvam, Ganesh S ; Kenneth, Lee K C ; Wai, Ng J ; Sheng, Lim J

OBJECTIVES:

To evaluate the cost-effectiveness of VEGF inhibitors, ranibizumab, aflibercept, bevacizumab, brolucizumab, pegaptanib, and conbercept for wAMD treatment.

METHODS:

A systematic search was conducted in PubMed, Cochrane, and SpringerLink databases to identify cost-effectiveness analyses and cost-utility analyses related to wAMD treatment. Eligible studies were assessed using Drummond's 10-point checklist to evaluate methodological quality. The extracted data included intervention costs, quality-adjusted life-years, and incremental cost-effectiveness ratios.

RESULTS:

Twenty-two studies met the inclusion criteria. Bevacizumab and brolucizumab were frequently reported as cost-effective alternatives, offering comparable or superior visual outcomes at lower costs than ranibizumab or aflibercept. Pegaptanib was consistently less cost-effective. Findings for ranibizumab versus aflibercept varied by treatment regimen and analytic assumptions. Across studies, cost-effectiveness estimates were influenced by model perspective, time horizon, exclusion of adverse events, and single-eye modeling. A further limitation is that in contexts of non-inferior efficacy, small incremental quality-adjusted life-years differences may artificially inflate incremental cost-effectiveness ratios, potentially overstating the costs relative to benefits.

CONCLUSIONS:

Decision making in wAMD treatment requires more thorough economic evaluations that incorporate standardized methodologies and lengthy cost assessments.

01 Mar 2026·ADVANCED DRUG DELIVERY REVIEWS

Biologics-device combinations: Enabling prolonged therapies in the posterior segment ocular disease

Review

Author: Jiang, Xuling ; Peng, Cheng ; Qian, Feng ; Liu, Huiqin ; Zhang, Jianjun ; Zhu, Shuqian

Posterior segment ocular diseases (e.g., age-related macular degeneration and diabetic retinopathy, etc.) often necessitate frequent intravitreal (IVT) injections of biologics, due to the rapid drug clearance and formidable ocular barriers. While molecular engineering strategies and high-concentration protein formulations could extend the administration intervals to a certain extent, they are confronted with critical challenges, protein aggregation, high viscosity, and limited duration. This has spurred the development of innovative biologics-device combination products, which represent a paradigm shift towards prolonged therapy. This comprehensive review examines the latest advancements of these combination platforms, including refillable implants (e.g., SUSVIMO®), encapsulated cell technology (e.g., ENCELTO™), and recombinant adeno-associated virus (rAAV) vectors (e.g., LUXTURNA®). The progress in biologics - device combination technologies has significantly reduced the frequency of ocular injections. However, substantial hurdles, such as instability caused by material-biologics interactions, potential risks during the sterilization and manufacturing processes, safety risks, and the evolving regulatory landscape, still need to be addressed. Achieving a balance between the stability of biologics and advanced device design, enhancing long-term safety, and developing responsive smart systems with real-time monitoring and feedback capabilities remain crucial for the advancement of next-generation ophthalmic therapies.

01 Feb 2026·JOURNAL FRANCAIS D OPHTALMOLOGIE

Article

Author: Maucourant, Y ; Le Pabic, E ; Naux, G ; Mouriaux, F ; Bellot, L

INTRODUCTION:

The goal of this study was to investigate the efficacy and safety of therapeutic switch of intravitreal injections (IVT) from ranibizumab 10mg/mL (Lucentis®) and aflibercept 40mg/mL (Eylea®) to FYB201 (Ranivisio®) in exudative age-related macular degeneration (AMD). This study includes an analysis of the direct medical cost of managing exudative AMD. The data studied included the mean injection interval in the year preceding the switch and the 9 months following, the longest dry interval over this period, the change in central retinal thickness, tolerance data, the sum of visit costs, treatment costs and an estimate of transportation costs.

MATERIALS AND METHODS:

Fifty-nine eyes of 46 patients treated for exudative AMD were included. Twenty-one eyes were treated with Lucentis® and 38 eyes with Eylea® before being switched to Ranivisio® between February 2023 and May 2024. The primary endpoint was the change in mean inter-injection interval in the pre-switch year versus the mean inter-injection interval in the 3 to 9 months post-switch.

RESULTS:

Patients received a mean of 7.5 IVT of anti-VEGF per eye in the pre-switch year, with a mean inter-injection interval of 6.2 weeks in Treat-and-Extend (TaE) schedule. The switch resulted in an extension of the mean inter-injection interval to 7.1 weeks (P=0.0004) and an extension of the longest dry interval (7.5 versus 6.39, P=0.0057) in the following 3 to 9 months. A reduction in central retinal thickness was observed at 3 months (247μm versus 261μm, P=0.0067), and no adverse effects were noted. In the year prior to switch, total medical costs per patient amounted to €9,397, with €6,542.00 (70%) in medication costs, €2,035.50 (21%) in ophthalmologic follow-up costs and €819.60 (9%) in transportation costs. After the switch, with a mean Ranivisio® inter-injection interval of 7.1 weeks, the annual treatment cost per eye was estimated at €2,388.00 for 7.33 annual IVTs.

DISCUSSION:

This study is consistent with data in the literature demonstrating the benefits of therapeutic switches in extending inter-injection intervals and improving retinal dryness, probably due to this method being a work-around for tachyphylaxis.

CONCLUSION:

Switching from Eylea® and Lucentis® to Ranivisio® is effective in exudative AMD, with a good safety profile, and could help to reduce treatment costs.

382

News (Medical) associated with Ranibizumab (Genentech)

29 Jan 2026

·www.biospace.com

[Ad hoc announcement pursuant to Art. 53 LR] Roche reports strong 2025 results with 7% sales growth

Group sales grew by 7% 1 at constant exchange rates (CER; 2% in CHF), driven by strong demand for medicines and diagnostic solutions. Sales in the fourth quarter increased by 8%, reflecting the positive momentum. Pharmaceuticals Division sales increased by 9% (3% in CHF), with Phesgo (breast cancer), Xolair (food allergies), Ocrevus (multiple sclerosis), Hemlibra (haemophilia A) and Vabysmo (severe eye diseases) being the top growth drivers. Diagnostics Division sales grew 2% (-3% in CHF) as demand for pathology and molecular solutions continued to more than offset the impact of healthcare pricing reforms in China. Core operating profit increased by 13% (5% in CHF), driven by higher sales and efficiency gains. Core earnings per share showed growth of 11% (4% in CHF); IFRS net income increased by 58% (50% in CHF), due to the strong operational performance in 2025 and the base effect of impairment charges in 2024. Highlights: US and EU approval for the subcutaneous form of Lunsumio for a type of blood cancer EU approval for Gazyva/Gazyvaro for lupus nephritis, a serious kidney disease Positive data on several therapies: (phase III) giredestrant for breast cancer, fenebrutinib for two forms of multiple sclerosis, Gazyva/Gazyvaro for two immune-related diseases, PiaSky for a rare, life-threatening kidney condition and Enspryng for a rare autoimmune disease that affects the brain, spinal cord and optic nerves; (phase II) CT-388 for obesity Advancement of 10 key molecules into phase III development in 2025 EU CE mark for novel Elecsys Dengue Ag test to diagnose dengue and for cobas BV/CV assay to improve diagnostic accuracy for women affected by vaginitis CE Mark for test to monitor antibiotic therapies, expanding the only automated mass spectrometry platform on the market to an in vitro diagnostic menu of 39 tests Board proposes a dividend increase to CHF 9.80 per share and non-voting equity security. If approved by shareholders, this would be the 39th consecutive dividend increase. Change in Board of Directors Outlook for 2026 Roche (SIX: RO, ROG; OTCQX: RHHBY) expects an increase in Group sales in the mid single digit range (CER) for 2026. Core earnings per share are targeted to develop in the high single digit range (CER). Roche expects to further increase its dividend in Swiss francs. Key figures CHF millions % change January–December 2025 2024 At CER 1 In CHF Group sales 61,516 60,495 7 2 Pharmaceuticals Division 47,669 46,171 9 3 Diagnostics Division 13,847 14,324 2 -3 Core operating profit 21,833 20,823 13 5 Core EPS – diluted (CHF) 19.46 18.80 11 4 IFRS net income 13,799 9,187 58 50 Roche CEO Thomas Schinecker : “2025 was a strong year for Roche, reflecting our continued focus on operational and R&D excellence. We have significant momentum across our pharmaceutical pipeline: ten potential new medicines advanced into final-stage development, and 12 late-stage clinical studies delivered positive results. We had important breakthroughs in lupus and oestrogen receptor-positive breast cancer, which accounts for approximately 70% of all breast cancer cases, as well as the first positive late-stage clinical results in a new therapy for multiple sclerosis. We are also setting new standards in diagnostics: our next-generation sequencing technology, which will be launched this year, decoded an entire human genome in less than four hours. With our strong financial performance and our continued progress in innovation, we are well positioned for growth.” Change in Board of Directors The Board of Directors will propose Lubomira Rochet (1977), Executive Vice President and member of the Group Executive Committee of Societe Generale, for election as a new Board member at the upcoming Annual General Meeting. Severin Schwan , Chairman of the Board: “Lubomira Rochet brings a broad leadership track record and deep experience in business transformations through digital and technology. I am very pleased that we can propose her for election to the Board of Directors.” As previously announced, Dr Claudia Suessmuth Dyckerhoff has decided not to stand for re-election as a member of the Roche Board of Directors at the Annual General Meeting in 2026. Group results In 2025, Roche achieved sales growth of 7% (2% in CHF) to CHF 61.5 billion due to strong demand for pharmaceutical products and diagnostic solutions. The appreciation of the Swiss franc against most currencies, notably the US dollar, had a significant impact on the results reported in Swiss francs compared to constant exchange rates. Core operating profit increased by 13% (5% in CHF) to CHF 21.8 billion, driven by higher sales and efficiency gains. Core earnings per share increased by 11% (4% in CHF). IFRS net income increased by 58% (50% in CHF) to CHF 13.8 billion due to the strong operating performance in 2025 and the base effect of impairment charges in 2024. Sales in the Pharmaceuticals Division increased by 9% (3% in CHF) to CHF 47.7 billion, with medicines for severe diseases continuing their strong growth. The top five growth drivers – Phesgo, Xolair, Ocrevus, Hemlibra and Vabysmo – achieved total sales of CHF 21.4 billion, an increase of CHF 3.2 billion (CER) compared to 2024. Sales of products with expired patents – Avastin (various types of cancer), Herceptin (breast and gastric cancer), MabThera/Rituxan (blood cancer, rheumatoid arthritis), Esbriet (lung disease), Lucentis (severe eye diseases) and Actemra/RoActemra (rheumatoid arthritis) – decreased by a combined CHF 0.7 billion (CER). In the United States , sales rose by 8% due to continued growth of Xolair and continuing uptake of Ocrevus, Phesgo, Hemlibra and Polivy (blood cancer). This growth more than compensated for the decline in sales of medicines with expired patents. Sales in Europe grew 5% as strong demand for Ocrevus and Vabysmo and the continuing uptake of Polivy, Hemlibra and Phesgo more than compensated for the lower sales of Perjeta (breast cancer) due to the ongoing conversion of patients to Phesgo, and the impact of biosimilar competition on Actemra/RoActemra sales. In Japan , sales increased by 5%, mainly due to the strong uptake of Phesgo, Vabysmo, Hemlibra, Enspryng (acute inflammation of optic nerve and spinal cord) and PiaSky (paroxysmal nocturnal haemoglobinuria). Sales growth was partially offset by the decline in sales of Avastin because of biosimilar erosion and Perjeta due to the continued conversion of patients to Phesgo. Sales in the International region rose by 14%, led by Phesgo, Xofluza (influenza), Hemlibra, Vabysmo, Elevidys (Duchenne muscular dystrophy) and Polivy. In China, sales rose by 10%, driven by the uptake of Phesgo due to the inclusion in the government drug reimbursement list, strong sales of Xofluza and the continued roll-out of Vabysmo and Polivy. The Diagnostics Division’s sales increased by 2% (-3% in CHF) to CHF 13.8 billion as growth in demand for pathology and molecular solutions more than offset the impact of healthcare pricing reforms in China. Sales in the Europe, Middle East and Africa (EMEA) region increased by 6%, driven by higher sales of clinical chemistry and immunodiagnostic products. In North America , sales increased by 9%, with growth across all customer areas. Sales in Asia-Pacific decreased by 12% due to healthcare pricing reforms in China. In Latin America , sales grew by 11%. Pharmaceuticals Division: pipeline With 66 new molecular entities (NMEs) and a total of 107 projects, Roche has a promising pipeline with a wide variety of therapeutic approaches. Pharmaceuticals research and development (R&D) expenditure decreased by 3% to CHF 10.4 billion (Group R&D: -3% to CHF 12.2 billion). Oncology remained the primary area for R&D, with substantial investments also in the areas of cardiovascular, renal and metabolism and immunology. Pharmaceuticals: key developments Compound Milestone Regulatory Lunsumio Blood cancer FDA approves Lunsumio VELO for subcutaneous use in relapsed or refractory follicular lymphoma Lunsumio VELO reduces administration time from 2‒4 hours to approximately 1 minute. Availability of Lunsumio VELO allows treatment aligned to people’s clinical needs and personal preferences. The approval is supported by data demonstrating compelling complete response rate in third-line or later treatment of people with follicular lymphoma, a disease that typically becomes harder to treat after each relapse. More information: Media Release , 22 December 2025 Gazyva/Gazyvaro Lupus nephritis European Commission approves Gazyva/Gazyvaro for adults with active lupus nephritis Approval based on phase II NOBILITY and phase III REGENCY studies showing superiority of Gazyva/Gazyvaro over standard therapy alone. Gazyva/Gazyvaro is the only anti-CD20 antibody to demonstrate a benefit in a complete renal response in lupus nephritis in a randomised phase III study. Gazyva/Gazyvaro could become a new standard of care for up to an estimated 135,000 people affected by lupus nephritis in the European Union, potentially helping to delay or prevent end-stage kidney disease. More information: Media Release , 9 December 2025 Lunsumio Blood cancer European Commission approves Lunsumio subcutaneous for relapsed or refractory follicular lymphoma Lunsumio provides high rates of deep and long-lasting responses in third-line and later treatment of people with follicular lymphoma, a disease that typically becomes harder to treat each time a patient relapses. Lunsumio subcutaneous offers a new treatment option that can significantly reduce administration time to approximately 1 minute. Lunsumio SC allows patients to receive treatment aligned to clinical requirements and lifestyle preferences. More information: Media Release , 19 November 2025 Phase III, pivotal and other key read-outs CT-388 Obesity Roche announces positive phase II results for its dual GLP-1/GIP receptor agonist CT-388 in people living with obesity A once-weekly subcutaneous injection of CT-388 achieved a statistically significant placebo-adjusted weight loss of 22.5% (p < 0.001) at 48 weeks at the highest dose tested (24 mg), without reaching a weight loss plateau. 54% of participants on the 24 mg dose achieved resolution of obesity (BMI <30 kg/m 2 ) vs 13% in the placebo group. CT-388 demonstrated a safety and tolerability pro consistent with that of its drug class with no new or unexpected safety signals. More information: Media Release , 27 January 2026 Giredestrant Breast cancer Giredestrant reduces risk of invasive disease recurrence or death by 30% in ER-positive early-stage breast cancer Giredestrant is the only oral SERD to show superior invasive disease-free survival in the adjuvant setting, marking the first significant endocrine therapy advance in over 20 years1‒3. Transformational results support the potential of giredestrant to become a new standard-of-care for early-stage disease. ER-positive breast cancer accounts for approximately 70% of breast cancer cases, and up to a third of patients experience recurrence on or after adjuvant endocrine therapy treatment. More information: Media Release , 10 December 2025 Lunsumio Blood cancer Roche presents Lunsumio data showing potential across earlier treatment lines in indolent and aggressive lymphomas Lunsumio in combination with lenalidomide may offer an effective treatment in relapsed or refractory follicular lymphoma based on first data from single-arm US cohort of phase III CELESTIMO study. Data from subcutaneous Lunsumio plus Polivy reinforce its outpatient, chemotherapy-free potential in people with relapsed or refractory large B-cell lymphoma. Results highlight the potential of innovative Lunsumio combination regimens to offer improved outcomes for more people with lymphoma earlier in their disease. More information: Media Release , 8 December 2025 Columvi Blood cancer Columvi combination shows sustained survival benefit at three-year follow-up of pivotal phase III STARGLO study Overall survival was twice as long for people treated with Columvi in combination with GemOx versus MabThera/Rituxan plus GemOx. This Columvi combination is available off-the-shelf and could offer a potentially curative treatment option for people with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL) who are not candidates for transplant. Columvi in combination with GemOx has now been approved in more than 50 countries worldwide and is recommended in international treatment guidelines. More information: Media Release , 8 December 2025 Giredestrant Breast cancer Giredestrant becomes the first oral SERD to show superior invasive disease-free survival in early breast cancer At interim analysis, giredestrant demonstrated a statistically significant and clinically meaningful benefit versus standard-of-care endocrine monotherapy. These unprecedented results support its potential as a new standard-of-care endocrine therapy in the early-stage setting. lidERA is the second positive phase III read-out for giredestrant following evERA presented at ESMO 2025. More information: Media Release , 18 November 2025 Fenebrutinib Multiple sclerosis Fenebrutinib shows unprecedented positive phase III results as the potential first and only BTK inhibitor in both relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS) The first pivotal RMS study (FENhance 2) met its primary endpoint, with fenebrutinib significantly reducing relapses compared to teriflunomide. In the pivotal PPMS study (FENtrepid), fenebrutinib slowed disability progression at least as effectively as Ocrevus, the only approved therapy in PPMS. Full data from both studies will be shared at upcoming medical meetings; all data will be considered for regulatory submission after the second RMS study (FENhance 1) reads out, expected in the first half of 2026. More information: Media Release , 10 November 2025 Haematology Roche presents new data from its broad and innovative haematology portfolio at ASH 2025 Findings demonstrate the effectiveness of Roche’s approved medicines in advancing treatment standards for people with blood disorders. Data from innovative pipeline signals progress towards improved outcomes in haemophilia A, lymphoma and multiple myeloma. More information: Media Release , 3 November 2025 Gazyva/Gazyvaro Systemic lupus erythematosus Positive phase III data for Gazyva/Gazyvaro show significant reduction in disease activity for systemic lupus erythematosus (SLE) Phase III ALLEGORY study met primary and all key secondary endpoints with Gazyva/Gazyvaro, demonstrating significant reduction in disease activity for SLE. Gazyva/Gazyvaro has the potential to become a transformative new standard of care for up to 3.4 million people affected by SLE worldwide, and would be the first anti-CD20 therapy for SLE to directly target B cells if approved. These positive results follow recent US FDA approval and positive EU CHMP opinion for Gazyva/Gazyvaro in lupus nephritis, as well as positive phase III data from the INShore study in idiopathic nephrotic syndrome. More information: Media Release , 3 November 2025 Gazyva/Gazyvaro Idiopathic nephrotic syndrome Positive phase III results for Gazyva/Gazyvaro in children and young adults with idiopathic nephrotic syndrome Gazyva/Gazyvaro versus mycophenolate mofetil shows significantly more children and young adults achieved sustained complete remission at week 52. If approved, Gazyva/Gazyvaro could help children and young adults sustain remission, potentially with a reduced need for steroids to manage their disease. INShore is the first global phase III study of a targeted therapy in this chronic kidney disease commonly diagnosed in early childhood. More information: Media Release , 28 October 2025 Other 89bio tender offer Roche completes tender offer for 89bio, Inc. shares and prepares to finalise acquisition Roche’s subsidiary Bluefin Merger Subsidiary, Inc. accepted for payment all shares validly tendered and not withdrawn in its tender offer for 89bio at USD 14.50 per share in cash plus a contingent value right for up to USD 6.00 per share. Approximately 94,113,710 shares, representing about 60.49% of 89bio’s outstanding common stock, were validly tendered and not withdrawn in the offer, and the tender offer expired on 29 October 2025. Roche intends to complete the acquisition of 89bio through a merger, after which 89bio will become a wholly owned subsidiary of Roche and its shares will be delisted from Nasdaq. More information: Media Release , 30 October 2025 Pharmaceuticals sales Sales CHF millions As % of sales % change January–December 2025 2024 2025 2024 At CER In CHF Pharmaceuticals Division 47,669 46,171 100.0 100.0 9 3 United States 25,355 24,774 53.2 53.7 8 2 Europe 9,164 8,832 19.2 19.1 5 4 Japan 2,882 2,874 6.0 6.2 5 0 International 10,268 9,691 21.6 21.0 14 6 International: Asia-Pacific, CEETRIS (Central Eastern Europe, Türkiye, Russia and Indian subcontinent), Latin America, Middle East, Africa, Canada, others Top 20 best-selling pharmaceuticals Total United States Europe Japan International CHF m % CHF m % CHF m % CHF m % CHF m % Ocrevus Multiple sclerosis 7,010 9 4,874 7 1,451 13 - - 685 21 Hemlibra Haemophilia A 4,754 11 2,665 6 1,002 10 377 8 710 38 Vabysmo Eye diseases (nAMD, DME, RVO) 4,102 12 2,857 3 741 21 146 22 358 116 Tecentriq Cancer immunotherapy 3,566 3 1,640 -2 878 3 349 -4 699 18 Xolair 2 Asthma, food allergies 3,075 32 3,075 32 - - - - - - Perjeta 2 Breast cancer 2,968 -13 1,268 0 552 -13 69 -37 1,079 -21 Actemra/RoActemra 2 RA, COVID-19 2,470 -2 1,206 -4 588 -9 310 5 366 16 Phesgo Breast cancer 2,441 48 708 31 812 12 188 44 733 172 Kadcyla 2 Breast cancer 2,025 7 768 6 532 -4 91 -3 634 22 Evrysdi Spinal muscular atrophy 1,757 13 612 10 616 9 90 1 439 25 Alecensa Lung cancer 1,562 6 565 14 262 -6 204 7 531 5 Polivy Blood cancer 1,470 38 688 28 290 53 207 9 285 87 MabThera/Rituxan 2 Blood cancer, RA 1,251 -4 794 0 140 -5 14 -11 303 -12 Activase/TNKase 2 Cardiac diseases 1,107 -2 1,056 -2 - - - - 51 -11 Herceptin 2 Breast and gastric cancer 1,028 -22 225 -10 291 -2 7 -43 505 -32 Gazyva/Gazyvaro 2 Blood cancer 986 14 519 19 245 2 35 25 187 15 Avastin 2 Various cancer types 973 -17 299 -17 70 -16 145 -23 459 -14 Pulmozyme 2 Cystic fibrosis 479 12 343 20 65 -9 1 -12 70 1 Xofluza Influenza 407 184 57 66 2 * - - 348 219 CellCept 2 Immunosuppressant 385 1 21 -5 131 8 44 17 189 -6 * Over 500% DME: diabetic macular edema / nAMD: neovascular or ‘wet’ age-related macular degeneration / RVO: retinal vein occlusion / RA: rheumatoid arthritis Diagnostics Division: portfolio In Diagnostics, Roche introduced two instrument platforms, six digital solutions and 53 new tests in 2025. The main areas of R&D activity included the development of high medical value assays, notably for the oncology disease area, as well as of digital solutions and sequencing. In addition, there were continuing investments in cardiometabolic diseases, particularly for continuous blood glucose monitoring. Diagnostics: key developments Product Milestone cobas Mass Spec solution Roche expands automated mass spectrometry menu with antibiotics drug monitoring CE mark approval offering industry’s broadest in vitro diagnostic menu With this approval, Roche’s automated mass spectrometry platform now offers the industry’s broadest in vitro diagnostic menu with 39 tests, including tests for therapeutic drug monitoring for immunosuppressants and antibiotics, as well as steroid hormones and vitamin D metabolites. The comprehensive menu brings the sensitivity and specificity of gold-standard testing into routine labs for a wide range of the most frequently tested targets. The fully automated solution replaces labour-intensive manual workflows, reducing turnaround times and supporting faster, standardised, high-quality care. More information: Media Release , 11 December 2025 cobas BV/CV test Vaginitis Roche launches new PCR test to help improve diagnostic accuracy for women affected by vaginitis in countries following the CE mark The new PCR test aids in the diagnosis of infectious causes of vaginitis through the detection of bacteria associated with bacterial vaginosis and yeast associated with candida vaginitis. The test will help improve diagnostic accuracy for millions of women affected by vaginitis annually, delivering more accurate and specific results. This test offers faster diagnosis by using a single vaginal swab for broader sexual health testing, eliminating the need for an additional sample. More information: Media Release , 9 December 2025 cobas liat Bordetella panel Infectious diseases Roche receives FDA clearance with CLIA waiver and CE mark for its first point-of-care test for diagnosing Bordetella infections, including whooping cough (pertussis) The point-of-care test delivers PCR-accurate results in just 15 minutes, enabling healthcare providers to act quickly and prevent severe complications and onward transmission. The test detects and differentiates between three types of Bordetella infection that can cause similar cough symptoms, ensuring patients receive the right diagnosis at the earliest opportunity. Early diagnosis can reduce the risk of complications and severe disease in vulnerable groups such as infants and the elderly, by enabling faster, more precise care decisions. More information: Media Release , 2 December 2025 Elecsys Dengue Ag test Dengue Roche receives CE mark for novel automated high-throughput Elecsys Dengue Ag test to diagnose dengue New dengue antigen test delivers high clinical sensitivity and specificity, as well as inclusivity for all four dengue virus serotypes, helping clinicians confidently distinguish dengue from other acute fever-causing illnesses. Full automation facilitates medium to high throughput and enables improvement of lab efficiency and test traceability, while reducing the risk of human error. Test delivers results in just 18 minutes, enabling faster laboratory workflows and patient management during outbreaks. More information: Media Release , 29 October 2025 Diagnostics sales Sales CHF millions As % of sales % change January–December 2025 2024 2025 2024 At CER In CHF Diagnostics Division 13,847 14,324 100.0 100.0 2 -3 Customer areas 3 Core Lab 7,614 8,011 55.0 55.9 0 -5 Molecular Lab 2,527 2,554 18.3 17.8 4 -1 Near Patient Care 1,983 2,160 14.3 15.1 -3 -8 Pathology Lab 1,723 1,599 12.4 11.2 14 8 Regions Europe, Middle East, Africa 4,965 4,822 35.9 33.7 6 3 North America 4,444 4,335 32.1 30.3 9 3 Asia-Pacific 3,386 4,099 24.4 28.6 -12 -17 Latin America 1,052 1,068 7.6 7.4 11 -1 More information on Roche’s performance in 2025: Finance Report 2025 Annual Report 2025 Full-year 2025 presentation Appendix with tables About Roche Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice. For over 125 years, sustainability has been an integral part of Roche’s business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit . All trademarks used or mentioned in this release are protected by law. References [1] Unless otherwise stated, all growth rates and year-on-year comparisons are at constant exchange rates (CER; average rates 2024) and all total figures quoted are reported in Swiss francs. [2] Products launched before 2015. [3] Core Lab: diagnostics solutions in the areas of immunoassays, clinical chemistry and CustomBiotech. Molecular Lab: diagnostics solutions for pathogen detection and monitoring, donor screening, sexual health and genomics, genomic tumour profiling. Near Patient Care: diagnostics solutions in emergency rooms, medical practices and directly with patients, including integrated personalised diabetes management. Pathology Lab: diagnostics solutions for tissue biopsies and companion diagnostics. In 2025, sales in the Pathology Lab customer area include sales previously reported in the Molecular Lab customer area to foster business transparency and harmonisation in the use of solutions in the area of cervical intraepithelial neoplasia technology (CINtec). The comparative information for 2024 has been restated accordingly. In 2025, sales in the Core Lab customer area include sales previously reported in the Near Patient Care customer area to centralise digital healthcare solutions within Roche Information Solutions. The comparative information for 2024 has been restated accordingly. Cautionary statement regarding forward-looking statements This document contains certain forward-looking statements. These forward-looking statements may be identified by words such as ‘believes’, ‘expects’, ‘anticipates’, ‘projects’, ‘intends’, ‘should’, ‘seeks’, ‘estimates’, ‘future’ or similar expressions or by discussion of, among other things, strategy, goals, plans or intentions. Various factors may cause actual results to differ materially in the future from those reflected in forward-looking statements contained in this document, such as: (1) pricing and product initiatives of competitors; (2) legislative and regulatory developments and economic conditions; (3) delay or inability in obtaining regulatory approvals or bringing products to market; (4) fluctuations in currency exchange rates and general financial market conditions; (5) uncertainties in the discovery, development or marketing of new products or new uses of existing products, including without limitation negative results of clinical trials or research projects, unexpected side effects of pipeline or marketed products; (6) increased government pricing pressures; (7) interruptions in production; (8) loss of or inability to obtain adequate protection for intellectual property rights; (9) litigation; (10) loss of key executives or other employees; and (11) adverse publicity and news coverage. The statement regarding earnings per share growth is not a profit forecast and should not be interpreted to mean that Roche’s earnings or earnings per share for this or any subsequent period will necessarily match or exceed the historical published earnings or earnings per share of Roche. Roche Global Media Relations Phone: +41 61 688 88 88 / E-mail: media.relations@roche.com Hans Trees, PhD Phone: +41 79 407 72 58 Sileia Urech Phone: +41 79 935 81 48 Nathalie Altermatt Phone: +41 79 771 05 25 Lorena Corfas Phone: +41 79 568 24 95 Simon Goldsborough Phone: +44 797 327 29 15 Karsten Kleine Phone: +41 79 461 86 83 Kirti Pandey Phone: +49 172 636 72 62 Yvette Petillon Phone: +41 79 961 92 50 Dr Rebekka Schnell Phone: +41 79 205 27 03 Roche Investor Relations Dr Bruno Eschli Phone: +41 61 687 52 84 E-mail: bruno.eschli@roche.com Dr Sabine Borngräber Phone: +41 61 688 80 27 E-mail: sabine.borngraeber@roche.com Dr Birgit Masjost Phone: +41 61 688 48 14 E-mail: birgit.masjost@roche.com Investor Relations North America Loren Kalm Phone: +1 650 225 32 17 E-mail: kalm.loren@gene.com Attachments Media Investor Release Roche FY 2025 English Communications appendix tables FY 2025 Results

Clinical ResultPhase 3Drug ApprovalPhase 2Acquisition

26 Jan 2026

·www.biospace.com

Samsung Epis Holdings Reports Fourth Quarter and Fiscal Year 2025 Financial Results

In its first financial results announcement after the spin-off, Samsung Bioepis recorded FY2025 revenue of KRW 1.672 trillion, highest annual revenue in its 14-year history Excluding milestone revenue, annual sales revenue grew 28% year-over-year (YoY), recording KRW 1.626 trillion, with 101% YoY growth in operating profit to KRW 330.8 billion INCHEON, Korea--(BUSINESS WIRE)-- #ADCs --Samsung Epis Holdings (KRX: 0126Z0), an investment company dedicated to innovations in biopharmaceuticals and biotechnology, today announced financial results for the fourth quarter and fiscal year 2025. “We are very pleased to report strong year-to-date sales growth in our first financial results following the spin-off. Our organic growth has been driven by solid performance across our biosimilars portfolio," said Kyung-Ah Kim, President and Chief Executive Officer (CEO) of Samsung Epis Holdings. “We are continuing to make meaningful progress in our regulatory and commercial milestones with our existing biosimilars portfolio, while strategically investing in our future pipeline with a disciplined, long-term approach. We aim to drive sustainable growth and create long-term value for our shareholders, so that we can remain committed to improving patient access worldwide.” Samsung Bioepis Fourth Quarter & Fiscal Year 2025 Results In the fourth quarter of 2025, Samsung Bioepis achieved a consolidated revenue of KRW 429.4 billion with an operating profit of KRW 29.2 billion. Revenue and operating profit based on product sales (excluding milestone revenue) in the fourth quarter increased by 23% and 14% year-over-year (YoY), respectively. Full-year 2025 (FY2025) revenue reached KRW 1.672 trillion (+9%) while operating profit stood at KRW 375.9 billion (-14%). Excluding milestone revenue, sales revenue and operating profit stood at KRW 1.626 trillion (+28%) and KRW 330.8 billion (+101%), respectively. [Consolidated Earnings, KRW billion] Q4’23 Q4’24 Q4’25 YoY Change FY23 FY24 FY25 YoY Change Revenue 288.9 397.4 429.4 +32.0 1 (+8%) 1,020.3 1,537.7 1,672.0 +134.3 1 (+9%) Excluding Milestone Revenue 288.9 347.0 425.2 +78.2 (+23%) 1,008.3 1,266.8 1,626.9 +360.1 (+28%) Operating Profit 78.2 72.3 29.2 -43.1 (-60%) 205.4 435.4 375.9 -59.5 (-14%) Excluding Milestone Revenue 78.2 21.9 25.0 +3.1 (+14%) 193.4 164.5 330.8 +166.3 (+101%) The growth was driven by Samsung Bioepis’ continued global expansion through product launches, regulatory approvals, and new partnerships. EPYSQLI™ (SB12), a biosimilar to Soliris 2 (eculizumab), indicated for the treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH), atypical Hemolytic Uremic Syndrome (aHUS), and generalized Myasthenia Gravis (gMG), was launched in the United States (US) in April 2025 through its commercialization partner Teva Pharmaceuticals, improving access for patients with rare diseases. OBODENCE™ / OSPOMYV™ 3 (SB16), a biosimilar to Prolia 4 (denosumab), and XBRYK™ (SB16), a biosimilar to Xgeva 3 (denosumab), were approved by the U.S. Food and Drug Administration (FDA) and the European Commission (EC) in February 2025. In Europe, OBODENCE was launched in December 2025, consequently followed by the launch of XBRYK in January 2026. As of January 2026, four products are directly commercialized by Samsung Bioepis in Europe, namely EPYSQLI (eculizumab), OBODENCE (denosumab), XBRYK (denosumab), and BYOOVIZ™ (ranibizumab). 5 PYZCHIVA™ (SB17), a biosimilar to Stelara 6 (ustekinumab), was launched in the US in partnership with Sandoz in February 2025. PYZCHIVA has also been available as private label brands since the second and third quarter of 2025. In Japan, SB17 was approved as Ustekinumab BS Subcutaneous Injection 45mg Syringes 「NIPRO」 by Pharmaceuticals and Medical Devices Agency (PMDA) in December 2025. It is the first product to gain marketing approval in Japan under the partnership with NIPRO CORPORATION entered in June 2025. Samsung Bioepis entered into a partnership agreement with Harrow for commercialization of BYOOVIZ (SB11), a biosimilar referencing Lucentis 7 (ranibizumab) and OPUVIZ™ (SB15), a biosimilar referencing Eylea 8 (aflibercept), in the US. Fiscal Year 2026 Outlook Samsung Epis Holdings is actively supporting its subsidiaries' core businesses under the holding company structure, with a goal of increasing global biosimilar sales by more than 10% compared YoY. Samsung Bioepis plans to secure 20 biosimilars in its portfolio by 2030, including dupilumab, guselkumab, ixekizumab, trastuzumab deruxtecan, vedolizumab, and ocrelizumab. Beyond biosimilars, the company has also embarked on its novel therapeutic development. It plans to have one novel therapeutic candidate enter into clinical study every year, starting with SBE303. SBE303 is Samsung Bioepis’ first novel antibody-drug conjugate (ADC) engineered to bind to Nectin-4, an adhesion protein that is specifically expressed in tumor cells, including bladder cancer, urothelial cancer, lung cancer, and breast cancer. 9 The Phase 1 first-in-human clinical trial, aiming to evaluate the safety, tolerability, efficacy, pharmacokinetics, and immunogenicity of SBE303 in participants with advanced refractory solid tumors, is set to begin this year. Epis NexLab, the new subsidiary under Samsung Epis Holdings, has launched a project to develop a peptide-based drug delivery platform. About Samsung Epis Holdings Co., Ltd. As an investment holdings company dedicated to biopharmaceuticals and biotechnology, Samsung Epis Holdings aims to maximize corporate and shareholder value through proactive R&D and investment and optimize business strategies for its subsidiaries, Samsung Bioepis and Epis NexLab. Samsung Epis Holdings continues to embrace future challenges and drive innovation by identifying new growth drivers and strengthening global collaboration platforms, thereby laying a solid foundation for the continued growth of its subsidiaries. For more information about Samsung Epis Holdings, please visit: . About Samsung Bioepis Co., Ltd. Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biologic candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, neurology, and endocrinology. For more information, please visit and follow us on LinkedIn and X . About Epis NexLab Co., Ltd. Established in 2025 as a 100% owned subsidiary of Samsung Epis Holdings, Epis NexLab is committed to driving innovation through the development of next-generation biotechnology platforms. By transforming highly scalable peptide-related technologies into development platforms, Epis NexLab is focused on the discovery of innovative treatment modalities for the development of multiple therapeutic candidates targeting a wide range of diseases. For more information about Epis NexLab, please visit: . 1 The year-over-year (YoY) change in operating profit is reflective of the ‘milestone payment’ – a payment system that pays out upon completion of specific milestones within a project’s development. 2 Soliris is a trademark of Alexion Pharmaceuticals, Inc. 3 SB16 was approved under different names in Europe and the US; OBODENCE in Europe and OSPOMYV in the US 4 Prolia and Xgeva are trademarks of Amgen Inc. 5 In Europe, Samsung Bioepis has assumed full responsibility for commercialization of BYOOVIZ upon the transfer of commercial rights from Biogen back to Samsung Bioepis, effective as of January 2026. 6 Stelara is a trademark of Johnson & Johnson Corporation. 7 Lucentis is a trademark of Genentech Inc. 8 Eylea is a trademark of Regeneron Pharmaceuticals, Inc 9 Li K, Zhou Y, Zang M, Jin X, Li X. Therapeutic prospects of nectin-4 in cancer: applications and value. Front Oncol. 2024 Mar 28;14:1354543. doi: 10.3389/fonc.2024.1354543. PMID: 38606099; PMCID: PMC11007101. Contacts Media Contact Yoon Kim, yoon1.kim@samsung.com Anna Nayun Kim, nayun86.kim@samsung.com

Drug ApprovalPhase 1

15 Jan 2026

·www.biospace.com

Samsung Epis Holdings Delivers Business Updates at the 44th J.P. Morgan Healthcare Conference

Samsung Bioepis plans to secure 20 biosimilars in its products and pipeline by 2030 The new pipeline will include dupilumab, guselkumab, ixekizumab, fam-trastuzumab deruxtecan-nxki, vedolizumab, and ocrelizumab, in addition to pembrolizumab currently in Phase 1 and 3 clinical studies Having secured investigational new drug application (IND) clearance from the U.S. Food and Drug Administration (FDA), SBE303, Samsung Bioepis’ novel antibody-drug conjugate (ADC) engineered to target Nectin-4, will enter into the Phase 1 first-in-human clinical trial this year Samsung Bioepis plans to add one novel therapeutic candidate in clinical study every year INCHEON, Korea--(BUSINESS WIRE)-- #ADC --Samsung Epis Holdings (KRX: 0126Z0) today shared corporate progress and updates at the 44th J.P. Morgan Healthcare Conference. "2026 is a monumental year for us, as we enter into a new chapter for our company. Today, we are announcing six additional candidates in our biosimilar pipeline, including vedolizumab and dupilumab. We are making great progress to secure 20 biosimilars in our portfolio by 2030," said Kyung-Ah Kim, President and Chief Executive Officer (CEO) of Samsung Epis Holdings. “We also received the investigational new drug application (IND) clearance for the first novel therapeutic candidate developed by Samsung Bioepis, and plan to advance our clinical program this year. As we broaden our portfolio beyond biosimilars, we will continue our development efforts in antibody-drug conjugates (ADCs), leveraging our innovative research and development platform to expand viable treatment options for patients with unmet needs.” Samsung Bioepis Biosimilar Updates Samsung Bioepis currently has 11 biosimilars for 10 unique biological molecules approved and launched in more than 40 countries. 1 The company has pembrolizumab biosimilar undergoing Phase 1 and 3 clinical studies, and plans to secure 20 biosimilars in its portfolio by 2030. The new pipeline will include dupilumab, guselkumab, ixekizumab, fam-trastuzumab deruxtecan-nxki, vedolizumab, and ocrelizumab. Novel Therapeutics Updates In December 2025, the FDA has cleared the IND Application for SBE303. SBE303 is Samsung Bioepis’ first novel ADC engineered to bind to Nectin-4, an adhesion protein that is specifically expressed in tumor cells, including urothelial cancer, lung cancer, and breast cancer. 2 The Phase 1 first-in-human clinical trial, aiming to evaluate the safety, tolerability, efficacy, pharmacokinetics, and immunogenicity of SBE303 in participants with advanced refractory solid tumors, is set to begin this year. Samsung Bioepis plans to have one novel therapeutic candidate enter into clinical study every year. Epis NexLab, the new subsidiary under Samsung Epis Holdings, has launched a project to develop a peptide-based drug delivery platform. Samsung Bioepis Biosimilars Portfolio Code Name (Brand Name 3 ) Non-proprietary Name Reference Product Status 4 SB5 (IMRALDI™, HADLIMA™, ADALLOCE™) Adalimumab Humira Launch SB4 (BENEPALI™, BRENZYS™, ETOLOCE™) Etanercept Enbrel Launch SB2 (FLIXABI™, RENFLEXIS™, REMALOCE™) Infliximab Remicade Launch SB3 (ONTRUZANT™, SAMFENET™) Trastuzumab Herceptin Launch SB8 (AYBINTIO™) Bevacizumab Avastin Launch SB11 (BYOOVIZ™, AMELIVU™) Ranibizumab Lucentis Launch SB12 (EPYSQLI™) Eculizumab Soliris Launch SB15 (OPUVIZ™, AFILIVU™) Aflibercept Eylea Launch SB16 (OBODENCE™, OSPOMYV™) Denosumab Prolia Launch SB16 (XBRYK™) Denosumab Xgeva Launch SB17 (PYZCHIVA™, EPYZTEK™) Ustekinumab Stelara Launch SB27 Pembrolizumab Keytruda Phase 1 and 3 Samsung Bioepis Biosimilar Candidates in Early Stage Development Non-proprietary Name Reference Product Dupilumab Dupixent Guselkumab Tremfya Ixekizumab Taltz Vedolizumab Entyvio Ocrelizumab Ocrevus Fam-trastuzumab deruxtecan-nxki Enhertu About Samsung Epis Holdings Co., Ltd. As an investment holdings company dedicated to biopharmaceuticals and biotechnology, Samsung Epis Holdings aims to maximize corporate and shareholder value through proactive R&D and investment and optimize business strategies for its subsidiaries, Samsung Bioepis and Epis NexLab. Samsung Epis Holdings continues to embrace future challenges and drive innovation by identifying new growth drivers and strengthening global collaboration platforms, thereby laying a solid foundation for the continued growth of its subsidiaries. For more information about Samsung Epis Holdings, please visit: . About Samsung Bioepis Co., Ltd. Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biologic candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, neurology, and endocrinology. For more information, please visit and follow us on LinkedIn and X . About Epis NexLab Co., Ltd. Established in 2025 as a 100% owned subsidiary of Samsung Epis Holdings, Epis NexLab is committed to driving innovation through the development of next-generation biotechnology platforms. By transforming highly scalable peptide-related technologies into development platforms, Epis NexLab is focused on the discovery of innovative treatment modalities for the development of multiple therapeutic candidates targeting a wide range of diseases. For more information about Epis NexLab, please visit: . 1 “more than 40 countries” signifies countries where Samsung Bioepis has commercial presence, with one or more products. 2 Li K, Zhou Y, Zang M, Jin X, Li X. Therapeutic prospects of nectin-4 in cancer: applications and value. Front Oncol. 2024 Mar 28;14:1354543. doi: 10.3389/fonc.2024.1354543. PMID: 38606099; PMCID: PMC11007101. 3 Different brand names for different regions and countries. 4 “Launch” signifies launch in one or more markets and does not necessarily indicate launch in all markets worldwide Contacts Media Contact Anna Nayun Kim, nayun86.kim@samsung.com Yoon Kim, yoon1.kim@samsung.com

Phase 1INDADC

100 Deals associated with Ranibizumab (Genentech)

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KEGG	Wiki	ATC	Drug Bank
D05697	Ranibizumab (Genentech)	S01LA04	DB01270

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Myopic choroidal neovascularization	United States	Formycon AG	18 Dec 2025
Diabetic Retinopathy	United States	Genentech, Inc.	06 Feb 2015
Retinal Vein Occlusion	Japan	Novartis Pharma AG	20 Aug 2013
Macular Edema	United States	Genentech, Inc.	22 Jun 2010
Age Related Macular Degeneration	Japan	Novartis Pharma AG	21 Jan 2009
Proliferative retinopathy with diabetes mellitus	Australia	Novartis Pharmaceuticals Australia Pty Ltd.	10 Nov 2008
Retinopathy of Prematurity	Australia	Novartis Pharmaceuticals Australia Pty Ltd.	10 Nov 2008
Vision, Low	Australia	Novartis Pharmaceuticals Australia Pty Ltd.	10 Nov 2008
Choroidal Neovascularization	European Union	Novartis Europharm Ltd.	22 Jan 2007
Choroidal Neovascularization	Iceland	Novartis Europharm Ltd.	22 Jan 2007
Choroidal Neovascularization	Liechtenstein	Novartis Europharm Ltd.	22 Jan 2007
Choroidal Neovascularization	Norway	Novartis Europharm Ltd.	22 Jan 2007
Diabetic macular oedema	European Union	Novartis Europharm Ltd.	22 Jan 2007
Diabetic macular oedema	Iceland	Novartis Europharm Ltd.	22 Jan 2007
Diabetic macular oedema	Liechtenstein	Novartis Europharm Ltd.	22 Jan 2007
Diabetic macular oedema	Norway	Novartis Europharm Ltd.	22 Jan 2007
Retinal vein occlusion-related macular edema	European Union	Novartis Europharm Ltd.	22 Jan 2007
Retinal vein occlusion-related macular edema	Iceland	Novartis Europharm Ltd.	22 Jan 2007
Retinal vein occlusion-related macular edema	Liechtenstein	Novartis Europharm Ltd.	22 Jan 2007
Retinal vein occlusion-related macular edema	Norway	Novartis Europharm Ltd.	22 Jan 2007

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Myopia, Degenerative	Phase 3	Japan	Novartis Pharmaceuticals Corp.	01 Oct 2010
Myopia, Degenerative	Phase 3	Austria	Novartis Pharmaceuticals Corp.	01 Oct 2010
Myopia, Degenerative	Phase 3	Canada	Novartis Pharmaceuticals Corp.	01 Oct 2010
Myopia, Degenerative	Phase 3	France	Novartis Pharmaceuticals Corp.	01 Oct 2010
Myopia, Degenerative	Phase 3	Germany	Novartis Pharmaceuticals Corp.	01 Oct 2010
Myopia, Degenerative	Phase 3	Hong Kong	Novartis Pharmaceuticals Corp.	01 Oct 2010
Myopia, Degenerative	Phase 3	Hungary	Novartis Pharmaceuticals Corp.	01 Oct 2010
Myopia, Degenerative	Phase 3	India	Novartis Pharmaceuticals Corp.	01 Oct 2010
Myopia, Degenerative	Phase 3	Italy	Novartis Pharmaceuticals Corp.	01 Oct 2010
Myopia, Degenerative	Phase 3	Latvia	Novartis Pharmaceuticals Corp.	01 Oct 2010

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04503551 (PAVILION, CTgov)	Phase 3	Diabetic macular oedema	174	Intravitreal Ranibizumab 0.5 mg Injection+100 mg/mL Ranibizumab	osnknpuevr = lxsvoxwilh poxvzlkccr (dlqomlzvxh, ypemrpmgnx - aosoxkjiku) View more	-	25 Nov 2025
SUMMIT (EURETINA2025)	Not Applicable	Wet age-related macular degeneration	46	Port-Delivery System with Ranibizumab	fpnndddxjc(obaznsnxwv) = zcjlbwdjwl ygmfgeyrad (mqqdefukgd ) View more	Positive	04 Sep 2025
NCT04108156 (Pagoda, EURETINA2025)	Phase 3	Diabetic macular oedema	241	Port Delivery System (PDS) with ranibizumab	xhoehlexyx(ycioijuzkj) = Incidence of key ocular AESIs (endophthalmitis, retinal detachment, vitreous haemorrhage) were similar across PDS-SE and IVT-FE (0.4% vs 0.4%, 0.4% vs 0.8%, 10.0% vs 7.5%, respectively). ybfcotabrb (absbvhqeqd )	Positive	04 Sep 2025
				any anti-vascular endothelial growth factor (VEGF) treatment
EURETINA2025	Not Applicable	Retinopathy of Prematurity	12	Ranibizumab	crvxxvvnta(wfywrcgchd) = There were no significant changes in the mean CFT and IRL thickness at 1 month (p=0.5 and 0.1 respectively). However, there was significant increase in the mean ORL thickness at 1 month (69.9±16, 96.1±25 at baseline and one month respectively, p<0.001), with differentiation (appearance of IS/OS junction ± ELM) in 55.6% of eyes. fdgcdhwddv (gqerofrvxq ) View more	Positive	04 Sep 2025
NCT03677934 (Archway, EURETINA2025)	Phase 3	Wet age-related macular degeneration	415	PDS with ranibizumab 100 mg/mL	xudkjoghlj(zgbiaoizop) = cyeozkiohu narlxgvaaa (rxetmljbpc, 3.7) View more	Positive	04 Sep 2025
				IVT ranibizumab 0.5 mg	xudkjoghlj(zgbiaoizop) = cvywqzigiv narlxgvaaa (rxetmljbpc, 3.2) View more
NCT00891735 (HARBOR, EURETINA2025)	Phase 3	Age Related Macular Degeneration	417	ranibizumab (T1)	bszyqtyoog(xsbaartdbe) = eiyolnspbt ffqnesiaar (mvksqlfkoh ) View more	Positive	04 Sep 2025
				ranibizumab (T2/mixed)	bszyqtyoog(xsbaartdbe) = shayehaaof ffqnesiaar (mvksqlfkoh ) View more
NCT03683251 (Portal, EURETINA2025)	Phase 3	Wet age-related macular degeneration	392	Port Delivery System with ranibizumab (PDS Q24W)	rleyjfgren(pulqrbmlnf) = vejtizhhjd ncbxtjtxxo (mudfjcodmf, -9.4 to -5.1) View more	Positive	04 Sep 2025
				Intravitreal ranibizumab 0.5 mg Q4W	rleyjfgren(pulqrbmlnf) = xyhiekdigm ncbxtjtxxo (mudfjcodmf, -10.5 to -4.6) View more
EURETINA2025	Not Applicable	Diabetic macular oedema \| Wet age-related macular degeneration	201	Ranibizumab	rjlljekisj(mmyavsfnce): P-Value = 0.003 View more	Positive	04 Sep 2025
				Ximluci
EURETINA2025	Not Applicable	Wet age-related macular degeneration	60	Biosimilar Ranibizumab	sltfnjxqpl(pggnpqiqgn) = ismaggxvoi gldlwoavnb (qfpfxnnkox ) View more	Positive	04 Sep 2025
NCT04108156 (Pagoda, EURETINA2025)	Phase 3	Diabetic macular oedema	509	PDS Q24W	mezctjegxc(ucksqagofp) = hjrfefsgsi lvebjaonyr (thmkqelssp ) View more	Positive	04 Sep 2025
				monthly ranibizumab 0.5 mg injections	mezctjegxc(ucksqagofp) = xwplmsmcga lvebjaonyr (thmkqelssp ) View more

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