Delving into the Latest Updates on Ranibizumab (Genentech) with Synapse

Overview

Basic Info

Drug Type

Fab fragment

Synonyms

ACCENTRIX, AMD Fab, AMD-rhuFab-V2

+ [19]

Target

VEGF-A

Action

inhibitors

Mechanism

VEGF-A inhibitors(Vascular endothelial growth factor A inhibitors)

Therapeutic Areas

Nervous System DiseasesCardiovascular DiseasesCongenital Disorders+ [3]

Active Indication

Diabetic RetinopathyRetinal Vein OcclusionMacular Edema+ [9]

Inactive Indication

Best Vitelliform Macular Dystrophy, MultifocalBlisterCentral retinal vein occlusion - ischemic+ [33]

Originator Organization

Genentech, Inc.

Active Organization

Novartis Europharm Ltd.Hoffmann-La Roche, Inc.

Genentech, Inc.

+ [8]

Inactive Organization

Novartis Pharmaceuticals Corp.

Beijing Novartis Pharma Co. Ltd.Roche Registration GmbH

+ [4]

License Organization

Novartis AG

Genentech, Inc.

Drug Highest PhaseApproved

First Approval Date

United States (30 Jun 2006),

Wet age-related macular degeneration

RegulationBreakthrough Therapy (United States), Fast Track (United States), Orphan Drug (Japan), Orphan Drug (Australia), Priority Review (China)

Login to view timeline

Structure/Sequence

Sequence Code 103170L

Source: *****

Sequence Code 143622H

Source: *****

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)

Login to view more data

100 Translational Medicine associated with Ranibizumab (Genentech)

Login to view more data

100 Patents (Medical) associated with Ranibizumab (Genentech)

Login to view more data

5,377

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.

06 Jun 2025·INVESTIGATIVE OPHTHALMOLOGY & VISUAL SCIENCE

Modeling the Ocular Pharmacokinetics and Pharmacodynamics of Ranibizumab for Improved Understanding and Data Collection Strategies in Ocular Diseases

Article

Author: Crawshaw, Jessica R. ; Gaffney, Eamonn A. ; Gertz, Michael ; Caruso, Antonello ; Maini, Philip K.

Purpose:

Improving our understanding of the ocular pharmacokinetics and pharmacodynamics of anti-vascular endothelial growth factor (VEGF) therapies, such as ranibizumab, is essential to enhance treatment strategies for a range of retinal diseases, and will help inform the development of novel anti-VEGF drug candidates.

Methods:

In this study, we examine a two-compartment pharmacokinetic/pharmacodynamic model of an intravitreal ranibizumab injection to understand its impact on ocular VEGF suppression. We use Bayesian inference to infer the model parameters from aqueous humor data extracted from healthy cynomolgus macaques. We leverage this approach to explore various sources of uncertainty in the data, offering practical recommendations for minimizing avoidable uncertainty.

Results:

The model provides a robust description of ranibizumab pharmacokinetics and pharmacodynamics, identifying the recovery region of the aqueous humor VEGF concentration-time profile as critical for the precise estimation of parameters. Our results advocate focusing on this region in future studies for optimal data collection. We consider standard data correction techniques to reduce the data uncertainty introduced by the lower limit of quantification, identifying the most preferable technique for this model and data. Using a Bayesian approach we obtain an inferred mean posterior distribution of 1459 ± 98 pM for the ranibizumab dissociation constant, a pharmacodynamic parameter with notable variability across the literature.

Conclusions:

This study extends our understanding of the ocular pharmacokinetics and pharmacodynamics of ranibizumab and provides theoretical insights for enhanced data collection schemes to be considered for clinical trials and in the development of novel anti-VEGF therapies.

06 Jun 2025·MEDICINE

Usage of brolucizumab as treatment for wet age-related macular degeneration (AMD) and polypoidal choroidal vasculopathy (PCV): A narrative review.

Review

Author: Jezani, Siti Nursyazanie ; Bastion, Mae-Lynn Catherine

Intravitreal anti-vascular endothelial growth factor (anti-VEGF) is the gold standard treatment for neovascular age-related macular degeneration (nAMD) which is responsible for central vision loss. This results in loss of quality of life, comparably severe to having coronary artery disease or cancer. New anti-VEGF agents need to address issues of potency and durability as existing agents tend to lose their effect after 1 month thus, requiring multiple injections at close intervals. Brolucizumab is one of the latest anti-VEGF agents clinically proven to treat nAMD after on-label agents namely, ranibizumab and aflibercept. Several clinical trials were conducted on Brolucizumab to ensure its safety and efficiency before it is approved to be used as treatment. Brolucizumab maintains and improves retinal edema in nAMD leading to improved vision with longer intervals possible between injections. However, it also has a risk of intraocular inflammation. This review summarizes the evidence for brolucizumab in the treatment of nAMD.

330

News (Medical) associated with Ranibizumab (Genentech)

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

27 May 2025

·pharma.economictimes.indiatimes.com

Lupin out-licenses eye disease biosimilar Latin America rights to SteinCares

Mumbai: Generics drug maker, Lupin has outlicensed its retinal disorder biosimilar ‘ ranibizumab ’ Latin America commercial rights (excluding Mexico and Argentina) to a healthcare company SteinCares . In a stock exchange filing Lupin announced that it has entered into a license and supply agreement with SteinCares, a healthcare company for commercialisation of the company’s biosimilar ranibizumab across Latin America excluding Mexico and Argentina. Under the terms of the agreement, Lupin will be responsible for manufacturing the drug and the other partner SteinCares will handle all regulatory filings, registrations and commercialization of the same across the markets. Ranibizumab is a recombinant humanized IgG1 monoclonal antibody fragment that binds to and inhibits vascular endothelial growth factor A (VEGF-A), that helps to prevent abnormal blood vessel growth and leakage in the retina, which is central to treating retinal disorders. Its indications encompass the treatment of patients with Neovascular (Wet) Age-Related Macular Degeneration (AMD), Macular Edema Following Retinal Vein Occlusion (RVO), Diabetic Macular Edema (DME), Diabetic Retinopathy (DR) and Myopic Choroidal Neovascularization (mCNV), the release stated. The drug is a biosimilar to Lucentis marketed by Genentech , a subsidiary of Swiss drugmaker Roche and Lupin has been marketing its ranibizumab biosimilar in India under the brand name RaniEyes since 2022. “Our intent is to transform the landscape of retinal care in Latin America, ensuring access to advanced therapies that improve the quality of life of patients,” Dr Cyrus Karkaria, President Biotechnology , Lupin commented. “We have consistently been first to market products from highly regulated markets across several countries in the region. Our presence has translated into significant cost savings, driven by decades of experience and a deep understanding of Latin America’s healthcare landscape,” Sebastián Katz, Chief Strategy Officer, SteinCares added. By Online Bureau ,

License out/inDrug Approval

27 May 2025

·pharma.economictimes.indiatimes.com

Lupin out-licenses eye disease biosimilar Latin America rights to SteinCares

Mumbai: Generics drug maker, Lupin has outlicensed its retinal disorder biosimilar ‘ ranibizumab ’ Latin America commercial rights (excluding Mexico and Argentina) to a healthcare company SteinCares . In a stock exchange filing Lupin announced that it has entered into a license and supply agreement with SteinCares, a healthcare company for commercialisation of the company’s biosimilar ranibizumab across Latin America excluding Mexico and Argentina. Under the terms of the agreement, Lupin will be responsible for manufacturing the drug and the other partner SteinCares will handle all regulatory filings, registrations and commercialization of the same across the markets. Ranibizumab is a recombinant humanized IgG1 monoclonal antibody fragment that binds to and inhibits vascular endothelial growth factor A (VEGF-A), that helps to prevent abnormal blood vessel growth and leakage in the retina, which is central to treating retinal disorders. Its indications encompass the treatment of patients with Neovascular (Wet) Age-Related Macular Degeneration (AMD), Macular Edema Following Retinal Vein Occlusion (RVO), Diabetic Macular Edema (DME), Diabetic Retinopathy (DR) and Myopic Choroidal Neovascularization (mCNV), the release stated. The drug is a biosimilar to Lucentis marketed by Genentech , a subsidiary of Swiss drugmaker Roche and Lupin has been marketing its ranibizumab biosimilar in India under the brand name RaniEyes since 2022. “Our intent is to transform the landscape of retinal care in Latin America, ensuring access to advanced therapies that improve the quality of life of patients,” Dr Cyrus Karkaria, President Biotechnology , Lupin commented. “We have consistently been first to market products from highly regulated markets across several countries in the region. Our presence has translated into significant cost savings, driven by decades of experience and a deep understanding of Latin America’s healthcare landscape,” Sebastián Katz, Chief Strategy Officer, SteinCares added. By Online Bureau ,

License out/inDrug Approval

100 Deals associated with Ranibizumab (Genentech)

Login to view more data

External Link

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

R&D Status

Approved

10 top approved records.

Login

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.

Login

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	Beijing Novartis Pharma Co. Ltd.	11 Sep 2013
Myopic choroidal neovascularization	Phase 3	China	Novartis Pharma Stein AG	11 Sep 2013
Myopic choroidal neovascularization	Phase 3	India	Novartis Pharma Stein AG	11 Sep 2013
Myopic choroidal neovascularization	Phase 3	India	Novartis Europharm Ltd.	11 Sep 2013
Myopic choroidal neovascularization	Phase 3	India	Beijing Novartis Pharma Co. 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	Beijing Novartis Pharma Co. Ltd.	11 Sep 2013

Login to view more data

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


JPRN-jRCTs011200010 (HGCSG 1903, ASCO_GI2025)	Phase 2	Advanced gastric carcinoma Second line	36	Ramucirumab plus Docetaxel	rfyumuvjax(yjqgtosqfm) = fxrwgovszl dzqeodiixj (zwognwvgce ) View more	Positive	23 Jan 2025
EURETINA2024	Not Applicable	intravitreal drugs	-	Eylea 2mg	iexvefwdob(tjkvrjxzud) = mqeomcwyyq hbgxogdjen (xmdoyejkaa )	Positive	19 Sep 2024
				Methotrexate	iexvefwdob(tjkvrjxzud) = pzrtzhfoxt hbgxogdjen (xmdoyejkaa )
EURETINA2024	Not Applicable	Retinopathy of Prematurity	131	Intravitreal injection of Ranibizumab 0.25 mg/0.025 ml	uvhoigmmwt(coiztgtgfu) = rjffxmycnz hjcbcwhyoi (qcjyydregt, 1.37) View more	Positive	19 Sep 2024
EURETINA2024	Not Applicable	Wet age-related macular degeneration	-	PDS with ranibizumab 100 mg/mL with fixed 24-week refill-exchanges (Q24W)	pmkbycxxkm(mpqhcbdizn) = lzeiaxkmit omklsjcslj (igmtrzlaha )	-	19 Sep 2024
				Intravitreal ranibizumab 0.5-mg injections every 4 weeks (monthly ranibizumab)	pmkbycxxkm(mpqhcbdizn) = lvhcxddbfy omklsjcslj (igmtrzlaha )
EURETINA2024	Not Applicable	Diabetic macular oedema	-	Ranibizumab (PDS Q24W)	mqtupvowub(rntgusprld) = bphrhqoxyq wikmhlwafb (gnsswmagtt, 8.7 - 1.5) View more	-	19 Sep 2024
				Monthly ranibizumab	mqtupvowub(rntgusprld) = bohxyrfvpx wikmhlwafb (gnsswmagtt, 8.3 - 10.5) View more
EURETINA2024	Not Applicable	Diabetic Retinopathy	-	Port Delivery System with ranibizumab Q36W	wwylgruhaj(bybsygkdfr) = No events of device dislocation were reported in either arm through W100 nnmxfziszr (gqkmrttanb ) View more	-	19 Sep 2024
				Ranibizumab (Control arm)
EURETINA2024	Not Applicable	Pregnancy	-	Aflibercept	jhcdistxwo(yzkxqlinfo) = roppwetybx sfcqyxkrgn (ytetczkaaj )	-	19 Sep 2024
				Bevacizumab	jhcdistxwo(yzkxqlinfo) = vferqtwyce sfcqyxkrgn (ytetczkaaj )
EURETINA2024	Not Applicable	Vitreous Hemorrhage	-	Intravitreal Ranibizumab	mzpujuqkoa(dfduhdbsml) = qjdfqrtmia nkkqfvsocl (nmwekmfrrf ) View more	-	19 Sep 2024
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)	ewokwqxmcs(mrztpcosbj) = 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 togdziejjh (xgoedcokkm ) View more	Positive	19 Sep 2024
				Monthly intravitreal ranibizumab injections
EURETINA2024	Not Applicable	Diabetic macular oedema	-	Aflibercept	kycpybzxqd(tukdlrmojp) = 73% of eyes lacking DRIL demonstrated nearly three times higher odds of CMT reduction compared to eyes with DRIL present (OR 2.9) vwbvrqcuyb (madwylkdgy ) View more	-	19 Sep 2024
				Ranibizumab

Login to view more data

Translational Medicine

Boost your research with our translational medicine data.

login

or

view full example data

Boost your research with our translational medicine data.

Deal

Boost your decision using our deal data.

login

or

view full example data

Boost your decision using our deal data.

Core Patent

Boost your research with our Core Patent data.

login

or

view full example data

Boost your research with our Core Patent data.

Clinical Trial

Identify the latest clinical trials across global registries.

login

or

view full example data

Identify the latest clinical trials across global registries.

Approval

Accelerate your research with the latest regulatory approval information.

login

or

view full example data

Accelerate your research with the latest regulatory approval information.

Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

login

or

view full example data

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

Understand key drug designations in just a few clicks with Synapse.

login

or

view full example data

Understand key drug designations in just a few clicks with Synapse.