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 Date19 Jun 2025

Sponsor / Collaborator

Hoffmann-La Roche Ltd.

[+1]

ChiCTR2400094335

/ SuspendedPhase 4IIT

A prospective, randomized, single-blind, multicenter case-control clinical trial comparing Ozurdex and ranibizumab in the treatment of Coats' disease

Start Date01 Jan 2025

Sponsor / Collaborator-

NCT05562947

/ RecruitingPhase 3

A Phase III, Multicenter, Randomized, Visual Assessor-masked, Active-comparator Study of the Efficacy, Safety, and Pharmacokinetics of the Port Delivery System With Ranibizumab in Chinese Patients With Neovascular Age-related Macular Degeneration

This study will evaluate the efficacy, safety, and PK of ranibizumab 100 milligrams per milliliter (mg/mL) delivered every 24 weeks (Q24W) via the PDS implant compared with ranibizumab 0.5 milligrams (mg) delivered every 4 weeks (Q4W) as intravitreal (IVT) injection in chinese participants with nAMD.

Start Date17 Jun 2024

Sponsor / Collaborator

Hoffmann-La Roche, Inc.

100 Clinical Results associated with Ranibizumab (Genentech)

100 Translational Medicine associated with Ranibizumab (Genentech)

100 Patents (Medical) associated with Ranibizumab (Genentech)

5,342

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: Igarashi, Ataru ; Sakashita, Naotaka ; 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 Apr 2025·Ophthalmology and Therapy

Efficacy, Safety, and Injection Frequency with Novel Aflibercept 8 mg in Neovascular Age-Related Macular Degeneration: A Comparison with Existing Anti-VEGF Regimens Using a Bayesian Network Meta-Analysis

Article

Author: Wojciechowski, Piotr ; Panek, Malgorzata ; Zhang, Xin ; Wdowiak, Marlena ; Lunk, Izabella ; Korobelnik, Jean-François ; Wu, Olivia ; Lanzetta, Paolo ; Carrasco, Joao

INTRODUCTION:

Aflibercept 8 mg administered in extended dosing intervals has shown non-inferior visual gains and comparable safety profile to aflibercept 2 mg in the PULSAR pivotal randomized clinical trial and has the potential to reduce the treatment burden of treating neovascular age-related macular degeneration (nAMD). This study aimed at gathering robust evidence to assess the comparative efficacy, safety, and treatment burden of aflibercept 8 mg against other anti-vascular endothelial growth factor (VEGF) agents as ranibizumab, brolucizumab, faricimab, and bevacizumab in patients with nAMD.

METHODS:

A systematic literature review (SLR) was conducted, targeting clinical trials of anti-VEGF agents in patients with nAMD. The results of the SLR were included in a network meta-analysis (NMA) comparing aflibercept 8 mg to other anti-VEGF treatments in nAMD, considering a 1-year time horizon. Treatment efficacy was assessed based on the change in best-corrected visual acuity (BCVA) from baseline, the proportion of patients gaining or losing 15 Early Treatment Diabetic Retinopathy Study (ETDRS) letters and changes in anatomical outcomes measured as change in central retinal thickness (CRT) or central subfield thickness (CST). Safety was assessed considering the incidence of ocular and non-ocular adverse events. Treatment burden was defined as the mean number of intravitreal injections over the study period.

RESULTS:

The base-case NMA involving 21 studies did not show significant differences between aflibercept 8 mg and comparators regarding BCVA change from baseline and proportion of patients with a gain or loss of ≥ 15 letters. On the anatomical endpoints, aflibercept 8 mg was associated with statistically significant improvement in CRT/CST change from baseline compared with ranibizumab in fixed and pro re nata regimens. No significant differences were identified versus the other anti-VEGF. The analysis of the safety outcomes did not identify any significant differences between aflibercept 8 mg and any of the comparators. During the first year of treatment, patients treated with aflibercept 8 mg (following 12- or 16-week injection intervals) received on average 5.9 and 5.1 injections, respectively. For the same period, patients treated with faricimab received from 6.2 to 6.7 injections, patients treated with ranibizumab from 7.62 to 12.14 injections, and patients treated with aflibercept 2 mg up to 7.67 injections.

CONCLUSION:

Aflibercept 8 mg demonstrates a comparable efficacy and safety to currently available anti-VEGF treatments for nAMD, with the potential added benefit of requiring fewer injections. These results suggest that aflibercept 8 mg could be a favourable treatment option for nAMD, achieving sustained disease control while alleviating the burden of injections on patients, caregivers, and healthcare providers.

01 Apr 2025·EXPERIMENTAL EYE RESEARCH

Nintedanib and ranibizumab attenuates pathological neovascularization in a rat model of oxygen induced retinopathy

Article

Author: Yazir, Yusufhan ; Ozturk, Ahmet ; Pirhan, Dilara ; Rencber, Selenay Furat ; Kılıc, Kamil Can ; Duruksu, Gokhan ; Basaran Emengen, Ece

314

News (Medical) associated with Ranibizumab (Genentech)

24 Mar 2025

·www.fiercebiotech.com

Opthea\'s eye disease drug defeated by Eylea in phase 3, leaving biotech to mull future

Opthea has wasted no time in reaching out to investors to see whether it can avoid debts and additional charges being called in.\n Only a month ago, Opthea was making preparations for the potential launch of a new eye disease drug onto the market. Now, the candidate has failed to match Eylea in a phase 3 trial, leaving the Australian biotech to consider its own future.The drug in question is sozinibercept, an inhibitor of vascular endothelial growth factors (VEGFs) C and D. Atea had been evaluating a 2-mg dose of sozinibercept every four or eight weeks in combination with Regeneron’s blockbuster VEGF inhibitor Eylea in patients with wet age-related macular degeneration (AMD) in a late-stage study.Patients receiving the combination therapy every four weeks or eight weeks saw a mean change in best corrected visual acuity at Week 52 of 13.5 and 12.8 letters, respectively, while patients who received Eylea only saw a slightly higher improvement of 13.7 letters.As well as failing on this primary endpoint, there was “no numerical difference observed in the key secondary endpoints,” Opthea noted. The biotech has wasted no time in reaching out to investors to see whether it can avoid debts and additional charges being called in. It will also make a decision on the future of the Coast trial and the phase 3 Shore trial—which is assessing sozinibercept in combination with Novartis’ Lucentis and is due to read out this year.“At this stage, no decision has yet been taken with respect to either trial, including whether to discontinue activities for the COAST trial or accelerate and unmask the ShORe trial,” Opthea said in the March 24 release. “Discussions continue with the DFA investors to determine the most appropriate course of action.”With $113.8 million in the bank as of the end of February, “there remains material uncertainty as to Opthea\'s ability to continue as a going concern,” the company added. The biotech has halted trading of its stock on both the Australian and Nasdaq exchanges while it works out a plan.The phase 3 fail marks an abrupt change in fortunes for Opthea, which had been confident enough in sozinibercept’s success to start gearing up its manufacturing activities in preparation for a potential commercial launch of the drug in wet AMD.The company joined the Nasdaq via a $128 million IPO in 2020. Investment enthusiasm for sozinibercept was driven by a phase 2 trial in which the drug bested Lucentis in wet AMD as well as “observed evidence of improved clinical outcomes” in a phase 1b/2a study in combination with Eylea in patients with treatment-refractory diabetic macular edema.

$Opthea\'s eye disease drug defeated by Eylea in phase 3, leaving biotech to mull future$

Phase 3Phase 2Clinical ResultIPOClinical Trial Failure

03 Mar 2025

·ir.opthea.com

Opthea Announces Phase 2b Wet AMD Publication - Opthea Limited, Inc

Baseline angiographic lesion characteristics predictive of clinical response Published in peer-reviewed journal Ophthalmic Surgery, Lasers and Imaging Retina MELBOURNE, Australia and PRINCETON, N.J., March 03, 2025 (GLOBE NEWSWIRE) -- Opthea Limited (ASX/NASDAQ: OPT “Opthea”, the “Company”), a clinical-stage biopharmaceutical company developing novel therapies to treat highly prevalent and progressive retinal diseases, including wet age-related macular degeneration (wet AMD), today announced the publication of sozinibercept Phase 2b data in the peer-reviewed journal Ophthalmic Surgery, Lasers and Imaging (OSLI) Retina. The paper entitled “Sozinibercept Combination Therapy for Neovascular Age-Related Macular Degeneration: Phase 2b Study Subgroup Analysis by Lesion Type” reports pre-specified and post-hoc analyses of angiographic predictors of response to sozinibercept combination therapy with ranibizumab in treatment-naïve patients with wet AMD. The analyses are based on choroidal neovascularization (CNV) type lesions (occult, minimally classic, and predominantly classic), and the presence and absence of retinal angiomatous proliferation (RAP) on visual acuity and anatomical outcomes. The data were derived from the randomized, controlled Phase 2b trial in which sozinibercept 2 mg combination therapy led to superior visual gains compared to ranibizumab monotherapy at 24 weeks. The Phase 2b pre-specified analyses of subgroups showed that in patients with occult and minimally classic lesions excluding RAP, which represented 73% of the Phase 2b total patient population, sozinibercept combination therapy demonstrated a statistically significant additional 5.7 letter mean gain in best corrected visual acuity (BCVA) compared to ranibizumab alone. A greater proportion of patients in this subgroup also gained ≥15 letters and had improved anatomy of better drying of the retina with reduced CNV area at week 24 compared to ranibizumab alone. “Angiographic lesion characteristics being predictive of patient response are consistent with data reported in real-world trials and have informed the design of Opthea’s sozinibercept Phase 3 clinical program,” said Frederic Guerard, PharmD, Chief Executive Officer of Opthea. “In fact, the patient demographics and baseline characteristics from COAST and ShORe include a high proportion of enrolled patients with these best responding lesion types. We are looking forward to the anticipated topline data readouts for COAST in early Q2 CY 2025 and for ShORe in mid-CY 2025.” Wet AMD remains the leading cause of vision loss in the elderly, impacting about 3.5 million people in the US and Europe alone. The unmet medical need in wet AMD is significant, with many patients failing to achieve optimal vision outcomes despite treatment with anti-VEGF-A therapies. About Opthea’s Clinical Development Program The Company’s pivotal Phase 3 wet AMD program is comprised of two fully enrolled, concurrent, multicenter, double-masked, randomized clinical trials, COAST (Combination OPT-302 with Aflibercept Study) and ShORe (Study of OPT-302 in combination with Ranibizumab). The trials are designed to assess the safety and superior efficacy of sozinibercept combination therapy versus standard-of-care anti-VEGF-A in wet AMD. The Phase 3 program is designed to support a broad label and, if successful, enable sozinibercept to be approved for use in combination with any anti-VEGF-A therapy in wet AMD patients. Sozinibercept has received Fast Track Designation from the US FDA for the treatment of wet AMD. To learn more about Opthea’s Phase 3 clinical trial program, please visit ClinicalTrials.gov for COAST, NCT04757636, and ShORe, NCT04757610. In Opthea’s prospective, randomized and controlled Phase 2b trial, including 366 treatment-naïve wet AMD patients, sozinibercept was administered in combination with standard-of-care ranibizumab for the treatment of wet AMD. Sozinibercept combination therapy met the pre-specified primary efficacy endpoint of a statistically superior gain in visual acuity at 24 weeks, compared to ranibizumab alone. In addition, secondary outcomes were positive with the combination therapy, including more patients gaining vision of 10 or more EDTRS letters, with improved anatomy, a reduction in swelling and vascular leakage, and a favorable safety profile. These statistically significant results were published in Ophthalmology in February 2023. About Opthea Opthea (ASX/NASDAQ:OPT) is a biopharmaceutical company developing novel therapies to treat vision-threatening eye diseases, including wet age‐related macular degeneration (wet AMD) and diabetic macular edema (DME), which remain leading causes of vision loss worldwide. Opthea’s lead product candidate in Phase 3 development, sozinibercept, is a first-in-class VEGF-C/D ‘trap’ inhibitor being evaluated in combination with standard-of-care anti-VEGF-A therapies to deliver superior vision to wet AMD patients. Sozinibercept has the potential to become the first therapy in 20 years to enable patients with wet AMD to live fuller and healthier lives. To learn more, visit our website at www.opthea.com and follow us on X and LinkedIn. Inherent Risks of Investment in Biotechnology Companies There are a number of inherent risks associated with the development of pharmaceutical products to a marketable stage. The lengthy clinical trial process is designed to assess the safety and efficacy of a drug prior to commercialization and a significant proportion of drugs fail one or both of these criteria. Other risks include uncertainty of patent protection and proprietary rights, whether patent applications and issued patents will offer adequate protection to enable product development, the obtaining of necessary drug regulatory authority approvals and difficulties caused by the rapid advancements in technology. Companies such as Opthea are dependent on the success of their research and development projects and on the ability to attract funding to support these activities. Investment in research and development projects cannot be assessed on the same fundamentals as trading and manufacturing enterprises. Therefore, investment in companies specializing in drug development must be regarded as highly speculative. Opthea strongly recommends that professional investment advice be sought prior to such investments. Forward-Looking Statements This ASX announcement contains certain forward-looking statements, including within the meaning of the US Private Securities Litigation Reform Act of 1995. The words “expect”, “believe”, “should”, “could”, “may”, “will”, “plan” and other similar expressions are intended to identify forward-looking statements. Forward-looking statements in this ASX announcement include statements regarding Opthea’s ongoing COAST and ShORe clinical trials, including the timing for anticipated topline data readouts and their potential to support a broad label and, if successful, to enable sozinibercept to be approved for use in combination with any anti-VEGF-A therapy in wet AMD patients; the potential benefits of sozinibercept, including to deliver superior visual outcomes in wet AMD when combined with standard-of-care anti-VEGF-A therapies and to become the first therapy in 20 years to enable patients with wet AMD live fuller and healthier lives; and the estimated patient population of wet AMD. Forward-looking statements, opinions and estimates provided in this ASX announcement are based on assumptions and contingencies which are subject to change without notice, as are statements about market and industry trends, which are based on interpretations of current conditions. Forward-looking statements are provided as a general guide only and should not be relied upon as an indication or guarantee of future performance. They involve known and unknown risks and uncertainties and other factors, many of which are beyond the control of Opthea and its directors and management and may involve significant elements of subjective judgment and assumptions as to future events that may or may not be correct. These statements may be affected by a range of variables which could cause actual results or trends to differ materially, including but not limited to future capital requirements, the development, testing, production, marketing and sale of drug treatments, regulatory risk and potential loss of regulatory approvals, ongoing clinical studies to demonstrate sozinibercept’s safety, tolerability and therapeutic efficacy, clinical research organization and labor costs, intellectual property protections, and other factors that are of a general nature which may affect the future operating and financial performance of the Company including risk factors set forth in Opthea’s Annual Report on Form 20-F filed with the US Securities and Exchange Commission (the “SEC”) on August 30, 2024, and other future filings with the SEC. Actual results, performance or achievements may vary materially from any projections and forward-looking statements and the assumptions on which those statements are based. Subject to any continuing obligations under applicable law or any relevant ASX listing rules, Opthea disclaims any obligation or undertaking to provide any updates or revisions to any forward-looking statements in this ASX announcement to reflect any change in expectations in relation to any forward-looking statements or any change in events, conditions or circumstances on which any such statement is based, except as otherwise required by applicable law. Authorized for release to ASX by Frederic Guerard, PharmD, CEO Join our email database to receive program updates: Tel: +61 (0) 3 9826 0399, Email: info@opthea.com Web: www.opthea.com Source: Opthea Limited Source: Opthea Limited

Phase 3Clinical ResultPhase 2Fast Track

13 Feb 2025

·www.businesswire.com

$16.99 Bn Eylea Market Opportunities and Strategies to 2033: New Formulations to Enhance Treatments, Biosimilars Enhancing Accessibility, Awareness Campaigns Driving Expansion - ResearchAndMarkets.com

DUBLIN--( BUSINESS WIRE )--The "Eylea Market Opportunities and Strategies to 2033" report has been added to ResearchAndMarkets.com's offering. This report describes and explains the Eylea market and covers 2018-2023, termed the historic period, and 2023-2028, 2033F termed the forecast period. The report evaluates the market across each region and for the major economies within each region. The global Eylea market reached a value of nearly $9.38 billion in 2023, having grown at a compound annual growth rate (CAGR) of 6.93% since 2018. The market is expected to grow from $9.38 billion in 2023 to $12.73 billion in 2028 at a rate of 6.31%. The market is then expected to grow at a CAGR of 5.94% from 2028 and reach $16.99 billion in 2033. The global Eylea market is highly concentrated, with large players operating in the market. The top competitor in the market, Regeneron Pharmaceuticals Inc accounted for 100% of the total market in 2023. Market-trend-based strategies for Eylea market include focus on new product launches to expand the range of treatment options and meet the evolving needs of patients, focus on awareness campaigns to educate both healthcare providers and patients about the importance of early detection and treatment of retinal diseases, focus on launching biosimilars to enhance market access and increase adoption, particularly in cost-sensitive regions and focus on strategic partnerships and collaborations to expand their market presence and accelerate innovation. Player-adopted strategies in the Eylea market include focus on enhancing operational capabilities through new launches, focus on enhancing operational capabilities through strategic partnerships, focus on developing new products to expand business into new geographies and focus on developing and launching new products to expand business expertise. Growth in the historic period resulted from the increased screen time, high prevalence of diabetes, public health campaigns on vision care, rising prevalence of ocular diseases and increased prevalence of diabetic retinopathy. Factors that negatively affected growth in the historic period was inadequate training for healthcare providers in administering Eylea. Going forward, increasing aging population worldwide, rising healthcare expenditure globally, supportive government initiative or funding, increasing rates of myopia-related retinal issues and expansion of eye care centers will drive the growth. Factor that could hinder the growth of the Eylea market in the future include high treatment costs of Eylea. The Eylea market is segmented by product into prefilled syringe package and vial package. The prefilled syringe package market was the largest segment of the Eylea market segmented by product, accounting for 75.89% or $7.11 billion of the total in 2023. Going forward, the prefilled syringe segment is expected to be the fastest growing segment in the Eylea market segmented by product, at a CAGR of 6.55% during 2023-2028. The Eylea market is segmented by disorder into wet age-related macular degeneration (AMD), diabetic retinopathy and other disorders. The wet age-related macular degeneration (AMD) market was the largest segment of the Eylea market segmented by disorder, accounting for 58.24% or $5.46 billion of the total in 2023. Going forward, the diabetic retinopathy segment is expected to be the fastest growing segment in the Eylea market segmented by disorder, at a CAGR of 6.95% during 2023-2028. The Eylea market is segmented by distribution channel into hospitals, retail pharmacy and other distribution channel. The hospitals market was the largest segment of the firefighting aircraft market segmented by distribution channel, accounting for 58.54% or $5.49 billion of the total in 2023. Going forward, the other distribution channel segment is expected to be the fastest growing segment in the Eylea market segmented by distribution channel, at a CAGR of 7.32% during 2023-2028. North America was the largest region in the Eylea market, accounting for 67.26% or $6.3 billion of the total in 2023. It was followed by Western Europe, Asia Pacific and then the other regions. Going forward, the fastest-growing regions in the Eylea market will be Asia Pacific and Western Europe where growth will be at CAGRs of 7.32% and 6.61% respectively. These will be followed by North America and South America where the markets are expected to grow at CAGRs of 6.30% and 5.43% respectively. To take advantage of the opportunities, the analyst recommends the Eylea companies to focus on new product launches, focus on awareness campaigns, focus on launching biosimilars, focus on prefilled syringe packages, focus on diabetic retinopathy, expand in emerging markets, continue to focus on developed markets, focus on strategic partnerships and collaborations, provide competitively priced offerings, continue to use B2B promotions, continue to use B2C promotions, focus on other distribution channels and focus on aging population worldwide. Opportunity Analysis The top opportunities in the Eylea market segmented by product will arise in the prefilled syringe package segment, which will gain $2.65 billion of global annual sales by 2028. The top opportunities in the eylea market segmented by disorder will arise in the wet age-related macular degeneration (AMD) segment, which will gain $1.91 billion of global annual sales by 2028. The top opportunities in the Eylea market segmented by distribution channel will arise in the hospitals segment, which will gain $1.95 billion of global annual sales by 2028. The Eylea market size will gain the most in the USA at $1.66 billion. Major Market Trends Launch of New Eylea Formulations to Enhance Treatment Options Strategic Awareness Campaigns Driving Market Expansion and Patient Engagement Launch of Biosimilars Enhancing Eylea Market Accessibility Strategic Partnerships and Collaborations Among Market players Key Mergers and Acquisitions Sandoz Group AG Completed the Acquisition of Cimerli, A Ranibizumab Biosimilar, From Coherus Biosciences Astellas Pharma Inc Acquired IVERIC Bio Inc Coherus BioSciences Inc Acquired Klinge Biopharma GmbH AbbVie Inc Acquired Regenxbio Inc Key Attributes: Report Attribute Details No. of Pages 277 Forecast Period 2023 - 2033 Estimated Market Value (USD) in 2023 $9.38 Billion Forecasted Market Value (USD) by 2033 $16.99 Billion Compound Annual Growth Rate 6.1% Regions Covered Global Key Topics Covered: 1. Executive Summary 1.1 Eylea - Market Attractiveness and Macro Economic Landscape 2. Table of Contents 3. List of Tables 4. List of Figures 5. Report Structure 6. Market Characteristics 6.1 General Market Definition 6.2 Summary 6.3 Eylea Market Definition and Segmentations 6.4 Market Segmentation by Product 6.4.1 Prefilled Syringe Package 6.4.2 Vial Package 6.5 Market Segmentation by Disorder 6.5.1 Wet-Age Related Macular Degeneration 6.5.2 Diabetic Retinopathy 6.5.3 Other Disorders 6.6 Market Segmentation by Distribution Channel 6.6.1 Hospitals 6.6.2 Retail Pharmacy 6.6.3 Other Distribution Channel Companies Featured Regeneron Pharmaceuticals Inc. Bayer AG Biocon Biologics Limited Samsung Bioepis Co. Ltd. Amgen Biosimilar Inc. Sandoz Formycon AG Celltrion Healthcare Inc. Alvotech SA Coherus BioSciences Inc. CS Pharmaceuticals Limited Sentiss Pharma Pvt Ltd. Sun Pharmaceutical Industries Limited Otsuka Pharmaceutical Co., Ltd. Rohto Pharmaceutical Co., Ltd. Takeda Pharmaceutical Company Chugai Pharmaceutical Co., Ltd. Santen Pharmaceutical Co., Ltd. Alteogen Novartis AG Nordic Pharma Bausch & Lomb Advanz Pharma Corp Novaliq GmbH Abbott Laboratories F. Hoffmann-La Roche AG Sanofi S.A. Johnson & Johnson AstraZeneca plc GSK plc Mylan N.V. Sandoz Group AG Klinge Pharma GmbH SIFI Alcon Inc. Saudi Pharmaceutical Industries and Medical Appliances Corporation (SPIMACO) MS Pharma Biovac For more information about this report visit https://www.researchandmarkets.com/r/526f3i About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

Acquisition

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
Myopia	Phase 3	China	Novartis Pharmaceuticals Corp.	11 Sep 2013
Myopia	Phase 3	Hong Kong	Novartis Pharmaceuticals Corp.	11 Sep 2013
Myopia	Phase 3	India	Novartis Pharmaceuticals Corp.	11 Sep 2013
Myopia	Phase 3	Philippines	Novartis Pharmaceuticals Corp.	11 Sep 2013
Myopia	Phase 3	South Korea	Novartis Pharmaceuticals Corp.	11 Sep 2013
Myopia	Phase 3	Thailand	Novartis Pharmaceuticals Corp.	11 Sep 2013
Myopic choroidal neovascularization	Phase 3	China	Beijing Novartis Pharma Co. Ltd.	11 Sep 2013
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	India	Novartis Europharm Ltd.	11 Sep 2013

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02510794 \| NCT03683251 \| NCT03677934 (Archway \| Portal \| Ladder, EURETINA2024)	Phase 2/3	Wet age-related macular degeneration vascular endothelial growth factor	-	Port Delivery System with ranibizumab (PDS)	iknlgsqgdp(uqnkfoocpz) = BCVA remained stable for 5 years, with an observed BCVA Snellen equivalent of 20/40 and mean (95% CI) change from baseline of −1.8 ETDRS letters (−8.1, 4.4; n=17) at month 60 kcptjydaah (rfrdqyiusn ) View more	Positive	19 Sep 2024
				Monthly intravitreal ranibizumab injections
EURETINA2024	Not Applicable	Diabetic macular oedema	-	Ranibizumab (PDS Q24W)	msydekbqqy(hidnxkuupl) = rbxnvhlwbk gpajrttpbo (uaootvqyfw, 8.7 - 1.5) View more	-	19 Sep 2024
				Monthly ranibizumab	msydekbqqy(hidnxkuupl) = tpqqojvefn gpajrttpbo (uaootvqyfw, 8.3 - 10.5) View more
EURETINA2024	Not Applicable	Diabetic Retinopathy	-	Port Delivery System with ranibizumab Q36W	urmfxmdxnl(ztdsgofhty) = No events of device dislocation were reported in either arm through W100 vujvzetxbe (ojpmquucme ) View more	-	19 Sep 2024
				Ranibizumab (Control arm)
EURETINA2024	Not Applicable	Vitreous Hemorrhage	-	Intravitreal Ranibizumab	toaugtrbxk(mgqfxxyrnu) = gwbfynfgqs wpiohepmjq (vxydjtfcoy ) View more	-	19 Sep 2024
EURETINA2024	Not Applicable	Wet age-related macular degeneration	-	PDS with ranibizumab 100 mg/mL with fixed 24-week refill-exchanges (Q24W)	iomtcgeqil(hqkniemsjs) = ilbtzczfmr zexfnufely (pxosbljgtv )	-	19 Sep 2024
				Intravitreal ranibizumab 0.5-mg injections every 4 weeks (monthly ranibizumab)	iomtcgeqil(hqkniemsjs) = pznwxbolqz zexfnufely (pxosbljgtv )
EURETINA2024	Not Applicable	Retinopathy of Prematurity	131	Intravitreal injection of Ranibizumab 0.25 mg/0.025 ml	tvyvnldvny(trdjjkqxun) = vpafpgzsot zbmfyytlip (yzwsvlaspi, 1.37) View more	Positive	19 Sep 2024
EURETINA2024	Not Applicable	Wet age-related macular degeneration	-	Intravitreal Ranibizumab (IVR)	fpdfilmcqm(fjgaxkyduf) = zqenwxrads evxxgukucd (ftqrkostdw ) View more	-	19 Sep 2024
				Intravitreal Aflibercept (IVA)	fpdfilmcqm(fjgaxkyduf) = jobbxecfbp evxxgukucd (ftqrkostdw ) View more
EURETINA2024	Not Applicable	intravitreal drugs	-	Eylea 2mg	vyylgtcwip(luqdsfbcoi) = lpvajosvph ckovhzuzlw (sinssdqyqo )	Positive	19 Sep 2024
				Methotrexate	vyylgtcwip(luqdsfbcoi) = unkkcbdixq ckovhzuzlw (sinssdqyqo )
EURETINA2024	Not Applicable	Diabetic macular oedema	-	Aflibercept	mmrgwsgszh(lgfcivlzyh) = 73% of eyes lacking DRIL demonstrated nearly three times higher odds of CMT reduction compared to eyes with DRIL present (OR 2.9) sbrouxespo (qopghgqrey ) View more	-	19 Sep 2024
				Ranibizumab
EURETINA2024	Not Applicable	Pregnancy	-	Aflibercept	cxcwebtbrt(yzcrrwmxkr) = kscmgvereb jkrnefvapy (pwwssykrff )	-	19 Sep 2024
				Bevacizumab	cxcwebtbrt(yzcrrwmxkr) = zkgmfifcip jkrnefvapy (pwwssykrff )

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