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 Date18 Nov 2025

Sponsor / Collaborator

Hoffmann-La Roche Ltd.

[+1]

NCT07007065

/ Not yet recruitingPhase 3

A Randomized, Controlled, Partially Masked, Phase 3b Study to Assess the Injection Burden, Efficacy, Safety, and Long-Term Preservation of Visual Acuity of Surabgene Lomparvovec (ABBV-RGX-314) in a Real-World Context in Subjects With Neovascular Age-Related Macular Degeneration (nAMD)

Neovascular age-related macular degeneration (nAMD), also known as "wet" AMD, is the abnormal growth of new blood vessels in the light-sensitive tissue at the back of the eye called the retina. The purpose of this study is to assess how safe and effective Surabgene Lomparvovec is in treating participants with Neovascular age-related macular degeneration (nAMD).
Surabgene Lomparvovec (ABBV-RGX-314) is an investigational gene therapy being developed for the treatment of neovascular age-related macular degeneration (nAMD). Participants will be placed into 1 of 3 groups, called treatment arms. Each group receives different treatment. Adult participants aged 50 and older years with a diagnosis of previously treated nAMD will be enrolled. Around 561 participants will be enrolled in the study at approximately 150 sites worldwide.
Participants in groups 1 and 2 will receive a single subretinal dose of ABBV-RGX-314. Participants in group 3 will receive Ranibizumab as needed throughout the study. Ranibizumab will be given as an intravitreal injection (injection into the jelly-like tissue that fills the eyeball injection), and ABBV-RGX-314 will be given as a subretinal (between the retina and the back of the eye) injection. The Assessment Period begins after randomization (1:1:1) to one of the ABBV-RGX-314 treatment groups or control at Week -2 and lasts up to 5 years.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular monthly visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Start Date17 Sep 2025

Sponsor / Collaborator

AbbVie, Inc.

ChiCTR2500095798

/ SuspendedEarly Phase 1IIT

Clinical study of regulatory T cell exosomes combined with VEGF antibody (Ranibizumab) in the treatment of refractory exudative age-related macular degeneration

Start Date16 Jan 2025

Sponsor / Collaborator

Hebei People's Hospital

100 Clinical Results associated with Ranibizumab (Genentech)

100 Translational Medicine associated with Ranibizumab (Genentech)

100 Patents (Medical) associated with Ranibizumab (Genentech)

5,394

Literatures (Medical) associated with Ranibizumab (Genentech)

31 Dec 2025·JOURNAL OF MEDICAL ECONOMICS

Cost-effectiveness analysis of bispecific antibody faricimab for treatment of neovascular age-related macular degeneration and diabetic macular edema in Japan

Article

Author: Sakashita, Naotaka ; Igarashi, Ataru ; Shoji, Ayako ; Higashi, Kentaro ; Tsujimura, Jun ; Ohno, Shinya ; Yanagi, Yasuo

OBJECTIVE:

To assess the cost-effectiveness of faricimab vs. other anti-vascular endothelial growth factor (anti-VEGF) drugs for treatment of neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME) in Japan, while considering societal burden associated with treatment.

METHODS:

A Markov model for cost-effectiveness analysis of anti-VEGF treatment in patients with nAMD and DME was applied based on cost and utility value data from Japan. Faricimab administered through a treat-and-extend (T&E) regimen was compared with ranibizumab administered pro re nata (PRN) and T&E, aflibercept T&E, brolucizumab T&E, and best supportive care (BSC). Further to treatment costs (public payer perspective), the societal burden (societal perspective), including costs of travel, informal care, and productivity, was assessed.

RESULTS:

In treatment of nAMD, lifetime quality-adjusted life years (QALYs) gained were highest with faricimab (faricimab T&E: 6.92, ranibizumab PRN: 6.88, ranibizumab T&E: 6.91, aflibercept T&E: 6.89, brolucizumab T&E: 6.89, BSC: 5.99). From the public payer perspective, the lifetime total cost for faricimab T&E was lower than those for ranibizumab (PRN, T&E) and brolucizumab (T&E), comparable to aflibercept T&E, and higher than BSC (incremental costs: 158,385 and 6,475,511 JPY, respectively). As a result, faricimab was cost-effective or dominant in the treatment of nAMD, excluding BSC. From the societal perspective, faricimab was dominant against all comparators in nAMD. In treatment of DME, QALYs gained were highest with faricimab (faricimab T&E: 8.51, ranibizumab PRN: 8.17, aflibercept PRN: 8.36, ranibizumab T&E: 8.13, BSC: 5.16). From both the public payer and societal perspectives, faricimab was dominant against all comparators in DME.

CONCLUSIONS:

When societal burdens were considered, faricimab was dominant in both nAMD and DME against all comparators, suggesting that the extended dosing interval associated with faricimab treatment may alleviate societal burdens and consequently improve patient outcomes.

01 Sep 2025·JOURNAL FRANCAIS D OPHTALMOLOGIE

Disease control, visual and anatomic outcomes at week 48 of brolucizumab treatment in patients with previously suboptimal anatomically controlled neovascular age-related macular degeneration – The SWIFT study

Article

Author: Delyfer, M-N ; Cohen, S Y ; Devin, F ; Baillif, S ; Ponthieux, A ; Kodjikian, L ; Souied, E H ; Aubry-Quenet, I ; Creuzot-Garcher, C ; Weber, M ; Couturier, A

PURPOSE:

Neovascular age-related macular degeneration (nAMD) patients refractory to one anti-vascular endothelial growth factor (VEGF) agent often switch to another anti-VEGF for better disease control. Our objective is to assess nAMD control with brolucizumab 6mg treatment in previously treated patients with suboptimal anatomical control.

METHODS:

SWIFT was a 48-week, prospective, single-arm, open-label clinical trial at 52 sites in France (NCT04264819). Participants were adults (≥ 50 years) with active CNV lesions secondary to nAMD, diagnosed<18 months, previously treated with either ranibizumab or aflibercept with a 4- or 8-week interval treatment, with baseline BCVA 38-83 letters. Eyes were treated with intravitreal brolucizumab 6mg at weeks 0, 4 and 8 (loading phase), followed by treat-to-control dosing with intervals up to 16 weeks, depending on investigator-assessed disease activity. The main outcome is the proportion of eyes without investigator-assessed disease activity at week 16.

RESULTS:

Two hundred and eighty-nine patients were included and analyzed (mean age 76.3 years, 61.9% female). Eyes were previously treated for a mean of 9.1 months. Baseline mean BCVA was 68.9 letters, and central subfield foveal thickness (CSFT) was 417μm. Over the course of the study, patients received a median of 6 brolucizumab injections (range: 1-8) with a mean (SD) treatment duration of 32.1 (14.1) weeks. The mean last brolucizumab treatment interval (SD) was 8.7 (3.5) weeks, notably longer than the interval of 6.2 (2.8) weeks with the previous anti-VEGF agent before inclusion in SWIFT. The proportion of eyes with no disease activity was 41.0% (95% CI: 34.4-47.9) at week 16 and 52.0% at week 48 (47.0 and 43.4%, respectively, using last observation carried forward sensitivity analysis). Improvements were observed from baseline to week 48 in BCVA (mean +3.2 [9.2] letters; P<0.0001), CFST (-66 [101] μm; P<0.0001). At week 48, 22% of eyes were on a regimen of every 12 weeks or more, and 40.4% of eyes had no retinal fluid (36.0 and 42.4% had intraretinal and subretinal fluid respectively). Intraocular inflammation (IOI) was confirmed in 29/295 (9.8%) eyes. Four of these patients had BCVA losses of≥15 letters at or after IOI resolution.

CONCLUSIONS:

In patients with refractory nAMD, brolucizumab allowed control of disease activity for up to 41.0% of patients, with visuals gains, anatomical improvements and extended treatment interval, despite poor response and discontinuation for some patients in addition to a 9.8% rate of IOI.

01 Jul 2025·Ophthalmology Retina

Impact of Duration of Exposure to Intraretinal Fluid on Visual Outcomes in Neovascular Age-Related Macular Degeneration

Article

Author: Steinle, Nathan C ; Du, Weiming ; McCullough, April J ; Silva, Fabiana Q ; Singh, Rishi P ; Moini, Hadi

OBJECTIVE:

To evaluate the impact of total duration of intraretinal fluid (IRF) exposure on visual acuity and vision-related quality of life in patients with neovascular age-related macular degeneration (nAMD).

DESIGN:

A post hoc analysis of integrated data from the VIEW 1 and VIEW 2 trials.

PARTICIPANTS:

Patients with nAMD.

METHODS:

Patients receiving intravitreal ranibizumab 0.5 mg every 4 weeks (Rq4) or intravitreal aflibercept injection (IAI) 2 mg every 4 weeks (2q4) or 2 mg every 8 weeks (2q8) were evaluated. Data were pooled across treatment groups, and the duration of IRF exposure was assessed by quartiles (first quartile [Q1]: ≤2 weeks; second quartile [Q2]: 3 to ≤8 weeks; third quartile [Q3]: 9 to ≤18 weeks; fourth quartile [Q4]: >18 weeks). Changes from baseline in visual acuity and vision-related quality of life were evaluated by quartiles of duration of IRF exposure in the pooled treatment group and each treatment group.

MAIN OUTCOME MEASURES:

Mean changes from baseline in best-corrected visual acuity (BCVA) and improvement in vision-related quality of life as assessed via National Eye Institute Visual Function Questionnaire-25 (VFQ-25) composite and subscale scores at week 52.

RESULTS:

A total of 1804 patients were evaluated. In the pooled analysis, mean BCVA gains from baseline at week 52 for Q1, Q2, Q3, and Q4 were +10.9, +10.1, +9.4, and +6.6 letters, respectively (Least squares mean difference Q4-Q1 [95% confidence interval]; -4.3 [-6.1, -2.5]). Mean changes from baseline to week 52 in VFQ-25 composite score for Q1, Q2, Q3, and Q4 were +5.9, +6.6, +6.1, and +4.0 points, respectively (-1.9 [-3.6, -0.2]). A similar trend was observed across VFQ-25 subscales, with patients in Q4 generally experiencing less improvement versus Q1. When BCVA gains were assessed by quartiles of duration of IRF exposure within each treatment group, mean BCVA gains for Q1, Q2, Q3, and Q4 were +11.0, +11.1, +9.3, and +5.8 letters for Rq4 (nominal P < 0.05; Q4 vs. Q1); +10.7, +9.7, +9.2, and +7.7 letters for IAI 2q4; and +11.3, +11.2, +8.6, and +6.3 letters for IAI 2q8 (nominal P < 0.05; Q4 vs. Q1), respectively.

CONCLUSIONS:

Increasing duration of IRF exposure was associated with lower visual gains and less improvement in vision-related quality of life in patients with nAMD.

FINANCIAL DISCLOSURE(S):

Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

332

News (Medical) associated with Ranibizumab (Genentech)

01 Jul 2025

·www.globenewswire.com

Bio Usawa Biotechnology and Bioeq AG Partner to Create Widespread Access to Vision-Saving Medicine Across Sub-Saharan Africa

Landmark partnership will democratize access to critical eye treatment for millions facing preventable blindness from diabetes complicationsKIGALI, Rwanda and SAN FRANCISCO and ZUG, Switzerland , July 01, 2025 (GLOBE NEWSWIRE) -- Bio Usawa Biotechnology Ltd. (Bio Usawa) and Bioeq AG today announced a groundbreaking agreement that will bring a life-changing biosimilar medicine—ranibizumab, used to treat serious retinal diseases—within reach for millions across Sub-Saharan Africa. This partnership grants Bio Usawa exclusive rights to register and commercialize Bioeq’s ranibizumab biosimilar under the brand name BioUcenta™, marking a critical step forward in democratizing access to essential biologic therapies across the region. Ranibizumab, a biosimilar to Lucentis®, is a monoclonal antibody used to treat diabetic macular edema (DME), wet age-related macular degeneration (AMD), and other blinding retinal diseases. While this breakthrough therapy has been transforming lives in higher-income countries for nearly 20 years, patients across Africa have been denied access due to prohibitive costs and limited availability. This partnership aims to end that disparity, bringing hope to millions who face preventable vision loss. “By making ranibizumab accessible in Sub-Saharan Africa, we are empowering doctors to save the vision of millions, particularly those suffering complications from diabetes—a disease that is quietly but rapidly becoming one of Africa’s greatest health threats,” said Dr. Menghis Bairu, Co-founder, President and CEO of Bio Usawa. "Our partnership with Bio Usawa is core to our commitment to expanding global access to essential medicines," said Martin Huber, Managing Director of Bioeq AG. "Together, we are breaking down the barriers that have denied effective treatment for serious retinal diseases to patients across Sub-Saharan Africa for too long. Bringing a high-quality, affordable ranibizumab biosimilar to this region is a significant step towards health justice." Africa is at the front line of a growing diabetes crisis. According to the International Diabetes Federation, more than 24 million Africans were living with diabetes in 2024, with that number projected to double by 2050. Diabetic retinopathy, a leading complication, threatens the sight of up to one-third of these patients. Without timely intervention, many will face blindness—an outcome that is both preventable and tragic. BioUcenta™, administered via intravitreal injection, works by blocking abnormal blood vessel growth in the retina and preventing fluid leakage—two key causes of vision loss. The biosimilar has already been approved in both Europe and the United States and will now be registered and distributed across Sub-Saharan Africa by Bio Usawa. “This collaboration is about equity,” added Dr. Bairu. “Access to advanced biologic therapies should not be a privilege of geography or income. We are proud to work with Bioeq to make this a reality for Africa—ensuring that patients, regardless of where they live, can receive the care they deserve.” The agreement marks the initial fulfillment of Bio Usawa's mission to democratize access to high-quality, affordable, and proven biotherapies in low-middle income countries. By establishing local capabilities and partnerships, the initiative creates a foundation for broader access to essential medicines across the continent. The partnership also represents a new model for global health equity, demonstrating how innovative collaborations can bridge the gap between life-saving medical advances and the patients who need them most. Rather than accepting that cutting-edge treatments remain exclusive to wealthy nations, this agreement shows how strategic partnerships can extend medical breakthroughs to underserved populations. About Bio Usawa Bio Usawa is an African biotechnology company with a mission to expand access to affordable, high-quality biosimilars across the continent. By combining deep industry experience with regional partnerships, Bio Usawa is building a future where life-saving biomedicines are made in Africa, by Africans, for Africans—and beyond. For more information, visit www.biousawa.com. About Bioeq AG Bioeq AG is a Swiss biopharmaceutical joint venture between Polpharma Biologics Group and Formycon AG. Bioeq develops and licenses biosimilars for global markets, combining innovation and quality to improve patient access to vital therapies. Learn more at www.bioeq.ch. Media Contact:Daniel LevineLevine Media Group+1 510-280-5405danny@levinemediagroup.com

Drug Approval

19 Jun 2025

·www.einpresswire.com

Seeing Beyond Sight: New Frontiers in AMD Treatment-Gene Therapy and Biosimilars Take Center Stage | CI Intelligence

Pioneering AMD therapies-gene therapy, biosimilars, long‑acting biologics-promise durable vision gains and reduced injection burden for aging populations. AMD treatment is entering a transformative era, where precision gene therapy and extended-duration biologics are redefining care. The market is poised to benefit both patients and healthcare systems.” — DataM Intelligence AUSTIN, TX, UNITED STATES, June 19, 2025 / EINPresswire.com / -- Revolutionizing AMD Care: From Monthly Injections to One-Time Gene Therapies In a watershed moment for retinal health, the Age-Related Macular Degeneration (AMD) therapeutics market is poised for transformation. A new wave of innovative treatments—from gene therapy to long-acting anti-VEGF biologics and biosimilars—is reshaping care protocols and expanding access for millions worldwide. With the global burden of AMD projected to surpass 300 million by 2040, the urgency to reduce injection frequency, slow disease progression, and improve affordability has never been more critical. Download CI Sample Report: https://www.datamintelligence.com/strategic-insights/ci/age-related-macular-degeneration-amd 🌍 Market Snapshot: AMD Therapeutics Poised for Growth - The global AMD therapeutics market was valued at approximately $14.24 billion in 2024, with expectations to reach $24.22 billion by 2033, registering a 6–8% CAGR over the forecast period. - North America remains the leading market due to high disease prevalence and early access to biologics, while Asia-Pacific is emerging rapidly with aging populations and increasing healthcare access. - Biosimilar competition, reimbursement reforms, and gene therapy innovations are key drivers shaping this growth trajectory. 🧬 Disease Overview: AMD at a Glance Age-related macular degeneration affects the macula—the central portion of the retina responsible for sharp, straight-ahead vision. It is the leading cause of irreversible vision loss in people aged 50 and older. Two Forms of AMD: - Dry AMD (Atrophic): The most common form, accounting for about 80% of cases. Characterized by thinning of the macula and drusen deposits. - Wet AMD (Neovascular): Less common but more severe. Marked by abnormal blood vessel growth beneath the retina, leading to leakage, scarring, and rapid vision loss. 💊 Current Therapies: Anti-VEGF Dominates, But GA Drugs Rising Wet AMD: Approved Therapies - Eylea (Aflibercept): VEGF and PlGF inhibitor, long-standing market leader. - Lucentis (Ranibizumab): Anti-VEGF monoclonal antibody fragment, widely adopted globally. - Beovu (Brolucizumab): Longer dosing intervals, though safety remains under scrutiny. - Vabysmo (Faricimab): Dual inhibition of VEGF-A and Ang-2; allows for 16-week dosing intervals. - Off-label Avastin (Bevacizumab): Economical alternative, frequently used off-label. Recent Developments: Biosimilars: Byooviz (ranibizumab-nuna), Yesafili, and Opuviz (aflibercept biosimilars) are now FDA-approved, offering cost-effective alternatives with similar efficacy. Dry AMD / Geographic Atrophy (GA): - Syfovre (Pegcetacoplan): First FDA-approved therapy for GA, slows disease progression by up to 36% by inhibiting complement C3. - Izervay (Avacincaptad Pegol): Approved in 2023; targets complement C5 to reduce retinal degeneration in GA. - AREDS2 Supplements and Photobiomodulation Therapy offer supportive care for early or intermediate dry AMD. 🔬 Emerging Therapies and Pipeline Highlights The AMD pipeline is robust, focusing on durable solutions and novel mechanisms of action. For Dry AMD (GA): - ALK-001 (Alkeus Pharmaceuticals): A modified vitamin A derivative in Phase II/III trials aimed at slowing photoreceptor degeneration. - Tinlarebant (Belite Bio): Oral therapy reducing retinal vitamin A buildup to slow GA progression (Phase III). For Wet AMD: - ABBV-RGX-314 (REGENXBIO/AbbVie): Gene therapy delivering anti-VEGF via subretinal or suprachoroidal injection. Phase III underway, with potential to eliminate frequent injections. - 4D-150 (4D Molecular Therapeutics): Intravitreal gene therapy targeting VEGF-A and VEGF-C for sustained delivery—Phase III trials are ongoing. Other Novel Agents: - UBX1325 (Unity Biotechnology): Senolytic targeting aging retinal cells to improve vision in AMD and DME. - Complement Inhibitors in Development: Aimed at upstream and downstream components (e.g., CFB, CFD, FD inhibitors). Ask For Customized CI Sample Report as per Your Business Requirement: https://www.datamintelligence.com/strategic-insights/ci/age-related-macular-degeneration-amd 📈 Market Opportunities & Forecasting - The wet AMD market continues to dominate revenue, but geographic atrophy (GA) is a growing segment due to newly approved treatments and expanding patient population. - Gene therapy and biosimilars are expected to drive a paradigm shift by improving durability and lowering long-term costs. - Market revenue is projected to grow from $14.24 billion (2024) to $24.22 billion by 2033, largely fueled by treatment innovation and the rising global prevalence of AMD. 🔍 Unmet Needs: The Next Frontier in AMD Care Despite progress, critical gaps remain: - Treatment Burden: Monthly injections are unsustainable for many elderly patients. Gene therapies and extended-interval dosing are key solutions. - Lack of Cure for Dry AMD: GA treatments slow degeneration but cannot reverse damage. - Global Access & Cost: High biologic prices remain a barrier in low- and middle-income countries. Biosimilars and oral agents offer scalable alternatives. - Delayed Detection: Early AMD often goes undiagnosed. Greater emphasis on screening and AI-enabled imaging is needed. - Personalized Medicine: Genotype-based AMD therapies remain underdeveloped, despite promising biomarker research. 🏆 Competitive Landscape and Strategic Positioning Key Players in Wet AMD: - Regeneron: Market leader with Eylea/Eylea HD. Facing competition from biosimilars and Roche’s Vabysmo. - Roche/Genentech: Innovator with Vabysmo and sustained delivery devices. - Novartis: With Beovu, pursuing longer dosing intervals. Leading in Dry AMD: - Apellis (Syfovre) and Astellas/Iveric Bio (Izervay) have pioneered complement-targeted approaches. Emerging Innovators: - REGENXBIO and Adverum Biotech: Leading the charge in gene therapy, aiming to provide one-time, durable treatment solutions. - Samsung Bioepis, Biocon, Polpharma: Disrupting the pricing landscape with Lucentis and Eylea biosimilars. Book Free CI Consultation Report: https://www.datamintelligence.com/strategic-insights/ci/age-related-macular-degeneration-amd 🎯 Target Opportunity Profile (TOP): Strategic Drug Benchmarking Ideal Drug Profile: - Wet AMD: ORR > 90%, injection frequency ≤ every 16 weeks, subcutaneous/gene therapy option. - GA: ≥30% reduction in lesion growth, good safety profile, ideally oral or less invasive. - Gene Therapy: One-time treatment, durable for 2–5+ years, minimal side effects. Benchmarking Snapshot: - Eylea HD: 12–16 week interval; market leader. - Vabysmo: Dual-target; fast-growing market share. - Syfovre & Izervay: First-movers in GA. - RGX-314 & 4D-150: Future disruptors with one-time treatment potential. - Yesafili, Opuviz: Cost-effective alternatives, expanding access. 💡 Conclusion: A Clearer Vision for Millions The Age-Related Macular Degeneration (AMD) landscape is evolving from high-frequency, high-cost injection therapies toward smarter, longer-lasting, and more accessible treatments. From breakthrough gene therapies to affordable biosimilars and the first-ever drugs for geographic atrophy, this is an era defined by innovation and opportunity. As the AMD patient population swells worldwide, driven by aging demographics, these advancements are not just medically vital—they’re a necessity for sustainable and equitable eye care. Read Related CI Report: 1. Atypical Hemolytic-Uremic Syndrome Therapeutic 2. Chronic Rhinosinusitis with Nasal Polyps Sai Kumar DataM Intelligence 4market Research LLP +1 877-441-4866 sai.k@datamintelligence.com Visit us on social media: LinkedIn X Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Phase 3Drug ApprovalGene Therapy

11 Jun 2025

·pharma.economictimes.indiatimes.com

CDMO OneSource obtains Xbrane biosimilars' manufacturing contract

Bengaluru: A multi-modality Contract Research and Development Organisation (CDMO) OneSource Specialty Pharma has obtained Xbrane Biopharma biosimilars manufacturing contract . OneSource and Xbrane , a Sweden-headquartered biotechnology company, have inked a strategic partnership focused on the commercial manufacturing of Xbrane’s biosimilar portfolio, the CDMO said in a release. Under the agreement Xbrane will transfer its commercial product (Tech Transfer) to OneSource’s state-of-the-art integrated Drug Substance and Drug Product (DS/DP) facility, however the contract value has not been disclosed by the company. The Swedish biotech will help the CDMO to obtain regulatory approvals including from the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA), for its biologics drugs substance facility. Recently, OneSource has also participated in Xbrane’s latest funding round, indicating a long-term strategic alignment between the two companies. According to OneSource, the drugmaker biosimilar’s respective reference products have a combined estimated annual sales of €23 billion (around ₹2.23 lakh crore). The company’s lead candidate Ximluci (a ranibizumab biosimilar ) has obtained market authorization approval in Europe and is under the approval process for the US launch. “The partnership with Xbrane reflects our shared ambition to drive broader access to cutting-edge biologics worldwide. We are pleased to support the scale-up of high-quality biosimilars and advance our vision of being a trusted partner to the world’s leading biotech companies,” said Neeraj Sharma, Managing Director & CEO OneSource Specialty Pharma. By Online Bureau ,

Drug ApprovalLicense out/in

100 Deals associated with Ranibizumab (Genentech)

External Link

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

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
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
Wet age-related macular degeneration	United States	Genentech, Inc.	30 Jun 2006

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Myopic choroidal neovascularization	Phase 3	China	Novartis Europharm Ltd.	11 Sep 2013
Myopic choroidal neovascularization	Phase 3	China	Novartis Pharma Stein AG	11 Sep 2013
Myopic choroidal neovascularization	Phase 3	China	Beijing Novartis Pharma Co. Ltd.	11 Sep 2013
Myopic choroidal neovascularization	Phase 3	India	Novartis Pharma Stein AG	11 Sep 2013
Myopic choroidal neovascularization	Phase 3	India	Beijing Novartis Pharma Co. Ltd.	11 Sep 2013
Myopic choroidal neovascularization	Phase 3	India	Novartis Europharm Ltd.	11 Sep 2013
Myopic choroidal neovascularization	Phase 3	South Korea	Novartis Europharm Ltd.	11 Sep 2013
Myopic choroidal neovascularization	Phase 3	South Korea	Beijing Novartis Pharma Co. Ltd.	11 Sep 2013
Myopic choroidal neovascularization	Phase 3	South Korea	Novartis Pharma Stein AG	11 Sep 2013
Myopic choroidal neovascularization	Phase 3	Thailand	Novartis Pharma Stein AG	11 Sep 2013

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04503551 (Pubmed \| JAMA Ophthalmol)	Phase 3	Nonproliferative diabetic retinopathy	174	Port Delivery System with Ranibizumab	sbyadcylas(gdzffuamst) = cataract, 7 participants [6.7%]; vitreous hemorrhage, 6 participants [5.7%]; conjunctival bleb, conjunctival retraction, and hyphema, each 2 participants [1.9%]; conjunctival erosion and retinal detachment, each 1 participant [1.0%] hpnsngauzi (udontrvsux )	Positive	01 Apr 2025
				Ranibizumab (Control (No PDS))
NCT04108156 (Pubmed \| JAMA Ophthalmol)	Phase 3	Diabetic macular oedema	634	Ranibizumab 100 mg/mL via PDS Q24W	pgtptuctxf(uksujsivku) = more common in the PDS Q24W group (88 participants; 27.5%) than the monthly ranibizumab group (28 participants; 8.9%) xricavpupv (wzwsznlhbf )	Positive	01 Apr 2025
				Monthly Ranibizumab 0.5 mg
NCT03683251 (Portal Extension Trial, Pubmed \| Ophthalmol Retina)	Phase 3	Wet age-related macular degeneration	555	PDS 100 mg/ml	xvbonfufef(cphhghbyyb) = 11.4% wkkytqbdih (csgtgodpsc ) View more	Positive	01 Feb 2025
				Monthly intravitreal ranibizumab 0.5-mg injections
JPRN-jRCTs011200010 (HGCSG 1903, ASCO_GI2025)	Phase 2	Advanced gastric carcinoma Second line	36	Ramucirumab plus Docetaxel	brotjokbpd(otacmmwwzb) = tnybkswsax zpoqjviacr (uhlkgoxrrc ) View more	Positive	23 Jan 2025
NCT03677934 (Archway, Pubmed \| Ophthalmol Retina)	Phase 3	anti-vascular endothelial growth factor therapy	418	Port Delivery System with ranibizumab (PDS)	ggiacbnxak(dvquuzkpab) = uatizxyovq iwtkycglgb (czcxdimrme ) View more	Positive	01 Oct 2024
				Monthly intravitreal ranibizumab injections	ggiacbnxak(dvquuzkpab) = sesgldgzrc iwtkycglgb (czcxdimrme ) View more
EURETINA2024	Not Applicable	Vitreous Hemorrhage	-	Intravitreal Ranibizumab	fvlzeyrbpv(yoikrgmuqx) = prfeyozngt kgksbxpvar (dtnmvvmthf ) View more	-	19 Sep 2024
EURETINA2024	Not Applicable	Diabetic macular oedema	-	Ranibizumab (PDS Q24W)	hbhqwsifbi(rfuivbogfg) = slxebqjfmi iqxuebdseu (aifihrvjph, 8.7 - 1.5) View more	-	19 Sep 2024
				Monthly ranibizumab	hbhqwsifbi(rfuivbogfg) = aqiwmsqyay iqxuebdseu (aifihrvjph, 8.3 - 10.5) View more
EURETINA2024	Not Applicable	Diabetic Retinopathy	-	Port Delivery System with ranibizumab Q36W	ukeantfnhp(glsricvsou) = No events of device dislocation were reported in either arm through W100 krttvjvtni (emxefzghjf ) View more	-	19 Sep 2024
				Ranibizumab (Control arm)
EURETINA2024	Not Applicable	Wet age-related macular degeneration	-	Intravitreal Ranibizumab (IVR)	mysxgewmtc(qjafobvdwq) = fqjnxmesto jsyzppausd (fkglrwkxob ) View more	-	19 Sep 2024
				Intravitreal Aflibercept (IVA)	mysxgewmtc(qjafobvdwq) = gvrflejqtt jsyzppausd (fkglrwkxob ) View more
EURETINA2024	Not Applicable	Retinopathy of Prematurity	131	Intravitreal injection of Ranibizumab 0.25 mg/0.025 ml	mgfjuqxnoc(zipjammbji) = tkdhiybyzd sngyttayzb (uthejtgcdr, 1.37) View more	Positive	19 Sep 2024

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