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 pharmacokinetics of ranibizumab 100 mg/mL delivered Q24W via the PDS implant compared with ranibizumab 0.5 mg delivered as a Q4W intravitreal injection in Chinese patients with nAMD.

Start Date17 Jun 2024

Sponsor / Collaborator

Hoffmann-La Roche, Inc.

TCTR20240924004 / CompletedNot ApplicableIIT

Evaluation of Sterility, Stability, and Efficacy of Repackaged Bevacizumab, Aflibercept, Ranibizumab, Brolucizumab, and Faricimab for Intravitreal Administration: An Experimental Study

Start Date10 Apr 2024

Sponsor / Collaborator-

CTR20222633 / RecruitingPhase 3

一项在中国新生血管性年龄相关性黄斑变性患者中评估雷珠单抗眼内港式给药系统的有效性、安全性和药代动力学特征的III 期、多中心、随机、视力评估员设盲、阳性对照研究

[Translation] A Phase III, multicenter, randomized, visual assessor-blinded, active-controlled study to evaluate the efficacy, safety, and pharmacokinetic characteristics of the intraocular port-type delivery system of ranibizumab in Chinese patients with neovascular age-related macular degeneration

本研究将在中国nAMD患者中评估与雷珠单抗0.5 mg Q4W玻璃体内注射相比，雷珠单抗100 mg/mL通过眼内港式给药系统植入Q24W给药的有效性、安全性和药代动力学特征。

[Translation]

This study will evaluate the efficacy, safety, and pharmacokinetic profile of ranibizumab 100 mg/mL administered Q24W via an intraocular port-type delivery system compared with ranibizumab 0.5 mg Q4W intravitreal injection in Chinese patients with nAMD.

Start Date02 Apr 2024

Sponsor / Collaborator

F. Hoffmann-La Roche Ltd.

[+2]

100 Clinical Results associated with Ranibizumab (Genentech)

100 Translational Medicine associated with Ranibizumab (Genentech)

100 Patents (Medical) associated with Ranibizumab (Genentech)

5,208

Literatures (Medical) associated with Ranibizumab (Genentech)

01 Feb 2025·AMERICAN JOURNAL OF OPHTHALMOLOGY

Submacular Hemorrhage Rates Following Anti-Vascular Endothelial Growth Factor Injections for Exudative Age-Related Macular Degeneration

Article

Author: Kaufmann, Gabriel T. ; Boucher, Nicholas ; Starr, Matthew R. ; Aggarwal, Nitika ; Kaufmann, Gabriel T ; Starr, Matthew R ; Sharma, Chakshu

PURPOSE:

To examine rates of submacular hemorrhage in patients undergoing anti-vascular endothelial growth factor (VEGF) injections, comparing rates between specific anti-VEGF agents.

DESIGN:

Retrospective clinical cohort study.

METHODS:

All patients in the database from January 2015 to November 2023 with a diagnosis of neovascular age-related macular degeneration and accompanying submacular hemorrhage (SMH). SMH prevalence and associated anti-VEGF injection type were analyzed in 140,915 eyes (of which 9107 had SMH) in a nationwide aggregated electronic health care database using chi-square test of proportion. Visual acuity (VA) data was assessed using 2-sample independent t-tests. The primary outcome was rate of SMH per injection type. Secondary datapoints examined were time between SMH diagnosis and last anti-VEGF injection, number of injections before SMH, treatment interval at time of SMH, VA before and at 12 months after SMH, eyes undergoing pars plana vitrectomy (PPV) within 30 days of SMH, and VA before PPV and at 12 months after PPV.

RESULTS:

The last injection type in eyes with SMH was bevacizumab in 3430 (37.8%) eyes, brolucizumab-dbll in 46 (0.51%) eyes, aflibercept in 3221 (35.4%) eyes. Ranibizumab in 2246 (24.7%) eyes, and faricimab-svoa in 155 (1.7%) eyes. Rates of SMH were significantly higher (P ≤ .001) for last injection with bevacizumab compared to every other injection type. Rates of SMH were significantly lower (P = .0004) for last injection with faricimab-svoa or ranibizumab injections each had significantly shorter (mean and standard deviation 48.9 (27.9), P < .02; mean and standard deviation 59.6 (38.2), P = .003, respectively) mean time between SMH diagnosis and last injection than did patients undergoing any other injection. Mean VA before SMH and at 12 months after SMH did not significantly differ by injection type among all patients. The number of patients who underwent PPV were 52 (1.51%) for bevacizumab, 4 (8.7%) for brolucizumab-dbll, 58 (1.8%) for aflibercept, 41 (1.8%) for ranibizumab, and 3 (1.9%) for faricimab-svoa. Mean VA before SMH and at 12 months after SMH did not significantly differ by injection type in patients undergoing PPV.

CONCLUSIONS:

Faricimab may be more protective than other anti-VEGF injections against SMH in patients with neovascular age-related macular degeneration.

01 Jan 2025·JOURNAL FRANCAIS D OPHTALMOLOGIE

Predictive factors of early reactivation after ıntravitreal ranibizumab in agressive retinopathy of prematurity

Article

Author: Cetinkaya, B. ; Oto, S. ; Torer, B. ; Oto, S ; Cetinkaya, B ; Yilmaz, G. ; Gülcan, H ; Torer, B ; Sahinoglu-Keskek, N ; Gülcan, H. ; Yilmaz, G ; Akkoyun, I. ; Akkoyun, I ; Sahinoglu-Keskek, N.

OBJECTIVE:

Anti-VEGF agents are used in the treatment of aggressive retinopathy of prematurity (A-ROP), which is a rapidly progressive form of retinopathy of prematurity (ROP). This study aimed to evaluate risk factors for the early reactivation after anti-VEGF therapy with intravitreal ranibizumab (IVR) injection.

METHODS:

Consecutive cases of A-ROP were included in this retrospective study. Intravitreal ranibizumab (0.25mg, Lucentis, Novartis AG) was injected in all A-ROP cases as initial therapy. Probable risk factors were reviewed. A reactivation in 4 weeks or less was defined as "early", and greater than 4 weeks was defined as "late". Since reactivations were observed in Zone II in all cases, laser photocoagulation (LP) was performed as rescue therapy.

RESULTS:

The study consisted of 16 patients with A-ROP, all of whom experienced reactivation. In 6 cases,reactivation was seen early (Group-E), and in 10 cases, reactivation was late (Group-L). The mean gestational age of Group-E and Group-L were 26.60 (±0.89) and 26.73 (±2.10) weeks respectively (P=0.9), and mean birth weights were 918 (±282) and 898 (±0188) grams respectively (P=0.8). Zone I ROP was seen at a higher rate in Group-E (83.3%) than Group-L (30%) (P=0.009). Total O₂ treatment duration in Group-E was statistically significantly longer than Group-L (P=0.03). The mean value of platelet distribution width (PDW) in Group-E was statistically significantly higher (P=0.002).

CONCLUSIONS:

In patients with A-ROP, extended duration of O₂ therapy and high values of PDW might be factors predictive of early reactivation after intravitreal ranibizumab injection.

01 Jan 2025·SURVEY OF OPHTHALMOLOGY

Evidence-based guidelines for drug dosing in intravitreal injections in silicone oil-filled eyes: Pharmacokinetics, safety, and optimal dosage

Review

Author: Loewenstein, Anat ; Zinkernagel, Martin ; Henderson, Robert ; Melo, Gustavo Barreto ; Chhablani, Jay ; Roth, Janice ; Bernardi, Enrico ; Wykoff, Charles C ; Fung, Adrian T ; Chou, Hung-Da ; Cheung, Chui Ming Gemmy ; Tsui, Edmund ; Querques, Giuseppe ; Sim, Peng Yong ; Wu, Xia Ni ; Subhi, Yousif ; Anguita, Rodrigo ; Kiilgaard, Jens Folke ; Ferro Desideri, Lorenzo ; Paschon, Karin ; Wykoff, Charles C. ; Melo, Gustavo ; Berrocal, Maria ; Desideri, Lorenzo Ferro

We evaluate the pharmacokinetics, safety, and optimal dosages of intravitreal agents in silicone oil (SO)-filled eyes, addressing challenges in administering such therapies. We assessed the pharmacological properties and safety profiles of intravitreal drugs in SO-filled eyes, deriving conclusions and guidance from available literature and expert consensus. Preclinical data suggest comparable half-lives of anti-vascular endothelial growth factoragents in SO-filled eyes, but clinical evidence is mainly from case reports and small series. Available research prioritizes standard dosages, particularly for bevacizumab (1.25 mg), supported by stronger evidence than aflibercept (2 mg) or ranibizumab (0.5 mg). Intravitreal steroids, especially dexamethasone at 0.7 mg, show efficacy and safety, while evidence for fluocinolone acetonide at 0.19 mg is limited. Intravitreal methotrexate has been reported at the dosage of 250-400 μg, with keratitis as the primary expected side effect. Case reports indicate tolerability of standard dosages of antivirals (foscarnet 1.2-2.4 mg/0.1 mL, ganciclovir 4 mg/0.1 mL) and the antibiotic combination piperacillin/tazobactam (250 μg/0.1 mL). We offer guidance based on current, but limited, literature. Standard dosage of intravitreal agents should be carefully considered, along with close monitoring for potential side effects, which should be discussed with patients.

319

News (Medical) associated with Ranibizumab (Genentech)

16 Dec 2024

·www.globenewswire.com

Roche’s Vabysmo prefilled syringe (PFS) approved in the EU for three retinal conditions that can cause blindness

Vabysmo PFS is the first and only prefilled syringe containing a bispecific antibody, offering a convenient alternative to currently available Vabysmo vials Vabysmo has demonstrated rapid and robust vision and anatomical improvements in neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME) and retinal vein occlusion (RVO) The ready-to-use Vabysmo PFS is co-packaged with the only CE-marked needle specifically designed for intravitreal injection 13 December 2024– Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Medicines Agency has approved Vabysmo® (faricimab) 6.0 mg single-dose prefilled syringe (PFS) for use in the treatment of neovascular or ‘wet’ age-related macular degeneration (nAMD), diabetic macular edema (DME) and macular edema following retinal vein occlusion (RVO). Together, these three conditions affect more than nine million people in the European Union (EU) and can have a devastating impact – physically, emotionally, and economically – on those affected, their families and caregivers.1-5 “Approval of the Vabysmo prefilled syringe in the EU offers a convenient way for ophthalmologists to administer this treatment for people with three of the most common causes of vision loss,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “This simplified administration may thereby help reduce the treatment burden for patients and retina specialists.” The Vabysmo PFS provides ophthalmologists with the first and only CE-labelled needle for intravitreal injection. Vabysmo PFS delivers the same medicine as the currently available 6.0 mg Vabysmo vials in an alternative, ready-to-use format.6 More than five million doses of Vabysmo have been distributed globally since its initial US approval in 2022.6-11 Vabysmo PFS was first approved for nAMD, DME and RVO by the United States Food and Drug Administration in July 2024.7 Vabysmo PFS will be the European Union’s first and only prefilled syringe containing a bispecific antibody to treat retinal conditions that can cause blindness. Vabysmo is the first bispecific antibody approved for the eye.7,8,12 It targets and inhibits two signalling pathways linked to a number of vision-threatening retinal conditions by neutralising angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A). Ang-2 and VEGF-A contribute to vision loss by destabilising blood vessels, causing new leaky blood vessels to form and increasing inflammation. By blocking pathways involving Ang-2 and VEGF-A, Vabysmo is designed to stabilise blood vessels.12,13 Vabysmo is approved in more than 100 countries around the world, including the United States (US), Japan, the United Kingdom and the European Union (EU) for people with neovascular or ‘wet’ age-related macular degeneration and diabetic macular edema, and in more than 30 countries, including the US, EU and Japan, for people with macular edema following retinal vein occlusion. Review by other health authorities is ongoing.6-11 Roche is focused on saving people’s eyesight from the leading causes of vision loss through pioneering therapies. Through our innovation in the scientific discovery of new potential drug targets, personalised healthcare, molecular engineering, biomarkers and continuous drug delivery, we strive to design the right therapies for the right patients. We have the broadest retina pipeline in ophthalmology, which is led by science and informed by insights from people with eye diseases. Our pipeline includes innovative treatments across different modalities, such as antibodies, and gene and cell therapies targeting multiple vision-threatening conditions, including retinal vascular and diabetic eye diseases, geographic atrophy, and autoimmune conditions, such as thyroid eye disease and uveitic macular edema. Applying our extensive experience, we have already brought breakthrough ophthalmic treatments to people living with vision loss. Susvimo® (previously called Port Delivery System with ranibizumab) 100 mg/mL for intravitreal use via ocular implant is the first United States Food and Drug Administration-approved refillable eye implant for neovascular or ‘wet’ age-related macular degeneration that continuously delivers a customised formulation of ranibizumab over a period of months.14,15 Vabysmo® (faricimab) is the first bispecific antibody approved for the eye, which targets and inhibits two signalling pathways linked to a number of vision-threatening retinal conditions by neutralising angiopoietin-2 and vascular endothelial growth factor-A.7,8,12,13 Vabysmo is approved around the world for people living with nAMD, diabetic macular edema and macular edema following retinal vein occlusion.6-11 Lucentis® (ranibizumab injection)* was the first treatment approved to improve vision in people with certain retinal conditions.16 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. References [1] National Institute for Health and Care Excellence. Macular degeneration – age-related: how common is it? [Internet; cited December 2024]. Available from: https://cks.nice.org.uk/topics/macular-degeneration-age-related/background-information/prevalence. [2] Bright Focus Foundation. Age-related macular degeneration: facts & figures. [Internet; cited December 2024]. Available from: https://www.brightfocus.org/macular/article/age-related-macular-facts-figures. [3] European Commission. Diabetes prevention. [Internet; cited December 2024]. Available from: https://knowledge4policy.ec.europa.eu/health-promotion-knowledge-gateway/diabetes-prevention. [4] Im JHB, et al. Prevalence of diabetic macular edema (DME) based on optical coherence tomography in people with diabetes: A systematic review and meta-analysis. Survey of Ophthalmology. 2022 Jul-Aug;67(4):1244-1251. [5] Li JQ, et al. Prevalence of retinal vein occlusion (RVO) in Europe: a systematic review and meta-analysis. Ophthalmologica. 2019;241(4):183-189. [6] European Medicines Agency. Summary of product characteristics, Vabysmo. 2024. [Internet; cited December 2024]. Available from: https://www.ema.europa.eu/en/documents/product-information/vabysmo-epar-product-information_en.pdf. [7] United States (US) Food and Drug Administration (FDA). Highlights of prescribing information, Vabysmo. 2024 [Internet; cited December 2024]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761235s005lbl.pdf. [8] Medicines and Healthcare products Regulatory Agency approves faricimab through international work-sharing initiative. [Internet; cited December 2024]. Available from: https://www.gov.uk/government/news/mhra-approves-faricimab-through-international-work-sharing-initiative. [9] Chugai obtains regulatory approval for Vabysmo, the only bispecific antibody in the ophthalmology field, for additional indication of macular edema associated with RVO. [Internet; cited December 2024]. Available from: https://www.chugai-pharm.co.jp/english/news/detail/20240326160000_1054.html. [10] Chugai obtains regulatory approval for Vabysmo, the first bispecific antibody in ophthalmology, neovascular age-related macular degeneration (nAMD) and DME. [Internet; cited December 2024]. Available from: https://www.chugai-pharm.co.jp/english/news/detail/20220328160002_909.html. [11] Roche data on file. [12] Heier JS, et al. Efficacy, durability, and safety of intravitreal faricimab up to every 16 weeks for nAMD (TENAYA and LUCERNE): two randomised, double-masked, phase III, non-inferiority trials. The Lancet. 2022; 399:729-40. [13] Wykoff C, et al. Efficacy, durability, and safety of intravitreal faricimab with extended dosing up to every 16 weeks in patients with DME (YOSEMITE and RHINE): Two randomised, double-masked, phase III trials. The Lancet. 2022; 399:741-755. [14] US FDA. Highlights of prescribing information, Susvimo. 2021. [Internet; cited December 2024]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761197s000lbl.pdf. [15] Holekamp N, et al. Archway randomised phase III trial of the Port Delivery System with ranibizumab for nAMD. Ophthalmology. 2021. [16] US FDA. Highlights of prescribing information, Lucentis. 2014. [Internet; cited December 2024]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125156s0069s0076lbl.pdf. The content above comes from the network. if any infringement, please contact us to modify.

Drug Approval

03 Dec 2024

·www.biopharmadive.com

Coherus, sharpening immuno-oncology focus, sells another biosimilar for over $500M

Coherus BioSciences has reached a deal to sell another one of its biosimilars as part of a plan to make cancer immunotherapies its focus going forward.The company on Tuesday said it will divest its Udenyca franchise, the name for its copycat version of Amgens Neulasta, to India-based drugmaker Intas Pharmaceuticals. Intas has agreed to pay Coherus over $483 million upfront, a figure thatll be adjusted for the companys inventory when the sale closes. Coherus could also get another $75 million should the drug hit certain sales targets.Coherus intends to use a large portion of the funds to pay off $230 million in convertible notes due 2026, and earmarked another roughly $49 million to buy out certain royalty obligations related to the drug. The company will shed other costs in the deal, too, as some employees involved with Udenyca will transfer to Intas, and other overhead as well as commercial expenses will be eliminated.For Coherus, the deal is the latest step in a rebranding thats been underway since 2021. Though the company was initially known for its work in biosimilars, its since become a player in cancer immunotherapy. A deal for rights to a type of checkpoint inhibitor developed by Junshi Biosciences yielded a drug, Loqtorzi, thats approved for nasopharyngeal carcinoma. An acquisition of Surface Oncology broadened its pipeline, which now includes a handful of experimental drugs in development for a variety of solid tumors. The company hopes to find new uses for Loqtorzi, in part by testing other drugs alongside it.In parallel, Coherus has been steadily offloading its biosimilars.In January, Coherus divested Cimerli, a biosimliar version of the eye drug Lucentis,for $170 million. The company followed with a $40 million sale of its Humira copycat in June, and now a much larger deal for Udenyca.The proposed divestiture of Udenyca represents the successful execution of our strategy to focus R&D and commercial resources on Coherus innovative immuno-oncology portfolio and to strengthen our financial position, said Denny Lanfear, Coherus CEO and chairman, in a statement.Coherus expects the deal to close in the first quarter of 2025. It will provide updated projections on its sales and cash runway next month. '

AcquisitionImmunotherapyDrug Approval

27 Nov 2024

·endpts.com

Outlook's shares crash as wet AMD drug flunks Phase 3 test

After the FDA rejected Outlook Therapeutics’ ophthalmic formulation of bevacizumab last year, the experimental therapy has now failed a late-stage study in patients with a degenerative eye disease. In a Phase 3 trial of 400 people with wet age-related macular degeneration (AMD), the biotech’s ONS-5010 missed the pre-specified non-inferiority endpoint of change in best corrected visual acuity (BCVA) at eight weeks versus Roche’s Lucentis. Outlook’s shares $OTLK were down about 75% on Wednesday morning after the data were announced. ONS-5010 led to a mean 4.2-letter improvement in BCVA compared with 6.3 letters for Lucentis in the Phase 3 study (p = 0.0863), according to Wednesday’s release . Despite missing the primary endpoint, the company said preliminary data showed an “improvement in vision” with ONS-5010 as well as “a continued favorable safety profile.” Outlook still plans to resubmit the drug in the first quarter of 2025 once it completes a final analysis of the results. Back in May, ONS-5010 secured EU approval for AMD under the brand name Lytenava. The company is working to launch the drug in the UK and Germany early next year. But regulatory efforts on the other side of the pond have proven more challenging after the drug received a complete response letter from the FDA in August 2023 citing “several CMC issues, open observations from pre-approval manufacturing inspections, and a lack of substantial evidence.” Prior to that, in March 2022, Outlook pulled its first BLA for ONS-5010 after the FDA requested additional information. The drug is an ophthalmic formulation of bevacizumab, an anti-VEGF monoclonal antibody approved for certain forms of cancer like Roche’s Avastin. Some ophthalmologists use “repackaged” versions of bevacizumab provided by compounders to treat wet AMD; ONS-5010 could offer a safer option, according to Outlook.

Phase 3Clinical ResultDrug Approval

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	US	Genentech, Inc.	06 Feb 2015
Age Related Macular Degeneration	JP	Novartis Pharma AG	21 Jan 2009
Proliferative retinopathy with diabetes mellitus	AU	Novartis Pharmaceuticals Australia Pty Ltd.	10 Nov 2008
Retinal vein occlusion-related macular edema	AU	Novartis Pharmaceuticals Australia Pty Ltd.	10 Nov 2008
Retinopathy of Prematurity	AU	Novartis Pharmaceuticals Australia Pty Ltd.	10 Nov 2008
Vision, Low	AU	Novartis Pharmaceuticals Australia Pty Ltd.	10 Nov 2008
Choroidal Neovascularization	EU	Novartis Europharm Ltd.	22 Jan 2007
Choroidal Neovascularization	IS	Novartis Europharm Ltd.	22 Jan 2007
Choroidal Neovascularization	LI	Novartis Europharm Ltd.	22 Jan 2007
Choroidal Neovascularization	NO	Novartis Europharm Ltd.	22 Jan 2007
Diabetic macular oedema	EU	Novartis Europharm Ltd.	22 Jan 2007
Diabetic macular oedema	IS	Novartis Europharm Ltd.	22 Jan 2007
Diabetic macular oedema	LI	Novartis Europharm Ltd.	22 Jan 2007
Diabetic macular oedema	NO	Novartis Europharm Ltd.	22 Jan 2007
Macular Edema	EU	Novartis Europharm Ltd.	22 Jan 2007
Macular Edema	IS	Novartis Europharm Ltd.	22 Jan 2007
Macular Edema	LI	Novartis Europharm Ltd.	22 Jan 2007
Macular Edema	NO	Novartis Europharm Ltd.	22 Jan 2007
Retinal Vein Occlusion	EU	Novartis Europharm Ltd.	22 Jan 2007
Retinal Vein Occlusion	IS	Novartis Europharm Ltd.	22 Jan 2007

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Myopia	Phase 3	CN	Novartis Pharmaceuticals Corp.	11 Sep 2013
Myopia	Phase 3	HK	Novartis Pharmaceuticals Corp.	11 Sep 2013
Myopia	Phase 3	IN	Novartis Pharmaceuticals Corp.	11 Sep 2013
Myopia	Phase 3	PH	Novartis Pharmaceuticals Corp.	11 Sep 2013
Myopia	Phase 3	KR	Novartis Pharmaceuticals Corp.	11 Sep 2013
Myopia	Phase 3	TH	Novartis Pharmaceuticals Corp.	11 Sep 2013
Myopic choroidal neovascularization	Phase 3	CN	Beijing Novartis Pharma Co. Ltd.	11 Sep 2013
Myopic choroidal neovascularization	Phase 3	CN	Novartis Europharm Ltd.	11 Sep 2013
Myopic choroidal neovascularization	Phase 3	CN	Novartis Pharma Stein AG	11 Sep 2013
Myopic choroidal neovascularization	Phase 3	IN	Novartis Europharm Ltd.	11 Sep 2013

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


EURETINA2024	Not Applicable	Vitreous Hemorrhage	-	Intravitreal Ranibizumab	aqshbtcgpe(jexgyqhgfg) = olodtulmeq mzfnusqlbz (roejzamxpt ) 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)	knuspvppva(sopipklzrr) = 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 krxrfthyuc (gonoolultw ) View more	Positive	19 Sep 2024
				Monthly intravitreal ranibizumab injections
EURETINA2024	Not Applicable	Wet age-related macular degeneration	-	Intravitreal Ranibizumab (IVR)	pdhipabyqn(pmhilwweyf) = dpjvpwtbmn zezcvwkxcl (fuqttjstez ) View more	-	19 Sep 2024
				Intravitreal Aflibercept (IVA)	pdhipabyqn(pmhilwweyf) = otgfjlxaka zezcvwkxcl (fuqttjstez ) View more
EURETINA2024	Not Applicable	Wet age-related macular degeneration	-	PDS with ranibizumab 100 mg/mL with fixed 24-week refill-exchanges (Q24W)	hveeyzymji(okzslysptv) = dzwmukbvvz mfdggxbyvj (wwiovpnwul )	-	19 Sep 2024
				Intravitreal ranibizumab 0.5-mg injections every 4 weeks (monthly ranibizumab)	hveeyzymji(okzslysptv) = thktuqayyg mfdggxbyvj (wwiovpnwul )
EURETINA2024	Not Applicable	Retinopathy of Prematurity	131	Intravitreal injection of Ranibizumab 0.25 mg/0.025 ml	mmcflsdrih(jioydxhqjm) = stjwyaihfl aukrmodcvz (kogmsarxbi, 1.37) View more	Positive	19 Sep 2024
EURETINA2024	Not Applicable	Diabetic macular oedema	-	Ranibizumab (PDS Q24W)	wnpynosjvb(jbrcsibmfb) = fpflfaccwu xfplmadlts (ehwyfxrogg, 8.7 - 1.5) View more	-	19 Sep 2024
				Monthly ranibizumab	wnpynosjvb(jbrcsibmfb) = oomsuykfqo xfplmadlts (ehwyfxrogg, 8.3 - 10.5) View more
EURETINA2024	Not Applicable	Diabetic Retinopathy	-	Port Delivery System with ranibizumab Q36W	imjtlxerqc(cqwnsrdeyp) = No events of device dislocation were reported in either arm through W100 gulmyfuhum (jckkmrtlyp ) View more	-	19 Sep 2024
				Ranibizumab (Control arm)
NCT04108156 (Pavilion, NEWS) Manual	Phase 3	Diabetic macular oedema \| Diabetic Retinopathy	-	Susvimo	dqvvvgzatc(jomzwvllin) = bqhjglacrv ovzhviwelt (rgmgafigaw )	Positive	18 Jul 2024
NCT02640664 (RAINBOW, Pubmed) Manual	Phase 3	Retinopathy of Prematurity vascular endothelial growth factor (VEGF)	201	Intravitreal ranibizumab 0.2 mg	jhvmqkeqlk(nypbffnsel) = pptdrtgcrd bofcmrjbmu (cfjkmhhkww, 62.9 - 70.7)	Positive	01 May 2024
				Intravitreal ranibizumab 0.1 mg	jhvmqkeqlk(nypbffnsel) = hxakkkcrrp bofcmrjbmu (cfjkmhhkww, 60.6 - 68.5)
NCT04108156 \| NCT04503551 (Pagoda \| Pavilion, APAO2024)	Phase 3	Diabetic macular oedema \| Diabetic Retinopathy	-	PDS Q24W	mybjrzcqou(ghfrjmoycc) = oyoixybqwz kbpzwvnfgd (lbmjvzejng, 0.2[-1.2 - 1.6]) View more	Positive	22 Feb 2024
				RBZ Q4W	mybjrzcqou(ghfrjmoycc) = ofkdvgjnxf kbpzwvnfgd (lbmjvzejng ) View more

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Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

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Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis