Delving into the Latest Updates on Faricimab with Synapse

Overview

Basic Info

Drug Type

Bispecific antibody

Synonyms

Faricimab, Faricimab (Genetical Recombination), Faricimab (genetical recombination)

+ [12]

Target

Ang2 x VEGF-A

Action-

Mechanism

Ang2 inhibitors(Angiopoietin-2 inhibitors), VEGF-A inhibitors(Vascular endothelial growth factor A inhibitors)

Therapeutic Areas

Cardiovascular DiseasesCongenital DisordersEndocrinology and Metabolic Disease+ [2]

Active Indication

Retinal Vein OcclusionRetinal vein occlusion-related macular edemaAge Related Macular Degeneration+ [11]

Inactive Indication

Wet Macular Degeneration

Originator Organization

F. Hoffmann-La Roche Ltd.

Active Organization

F. Hoffmann-La Roche Ltd.

Chugai Pharmaceutical Co., Ltd.Hoffmann-La Roche, Inc.

+ [9]

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

United States (28 Jan 2022),

Diabetic macular oedemaWet age-related macular degeneration

RegulationOrphan Drug (United States), Priority Review (United States)

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Structure/Sequence

Sequence Code 103170L

Source: *****

Sequence Code 9508434L

Source: *****

Sequence Code 9508445H

Source: *****

Sequence Code 9508453H

Source: *****

This study is a Phase IIIb/IV, multicenter, randomized, two-arm, open-label 100-week study to investigate the efficacy, safety, and durability of intravitreal 6-mg faricimab administered at up to 24-week intervals in patients with neovascular age-related macular degeneration (nAMD) that are treatment-naïve in the study eye.

Start Date11 Apr 2025

Sponsor / Collaborator-

NCT06709339

/ Not yet recruitingPhase 4IIT

A Phase IV, Multicentre, Open-label, Single-arm Study to Investigate the Efficacy, Safety and Durability of Faricimab (RO6867461) in Caucasian Patients With Polypoidal Choroidal Vasculopathy

The goal of this clinical trial is to assess the efficacy, safety and durability of faricimab in caucasian patients with polypoidal choroidal vasculopathy (PCV). The main question it aims to answer is:
To evaluate the efficacy of intravitreal (IVT) injections of faricimab 6 milligrams (mg) on Best Corrected Visual Acuity (BCVA) outcomes in caucasian patients with symptomatic macular PCV.
Participants will undergo ophthalmic examination, safety assessment and treatment with faricimab according to a patient specific treat and extend regimen.

Start Date01 Apr 2025

Sponsor / Collaborator

Association For Innovation & Biomedical Research

NCT06790784

/ Not yet recruitingPhase 3IIT

A Randomized Clinical Trial Evaluating Combination Faricimab + PRP vs. Vitrectomy + Endolaser for Treatment of Proliferative Diabetic Retinopathy

This randomized trial will compare treatment strategies for proliferative diabetic retinopathy (PDR). Participants will receive either combination a of faricimab + PRP or vitrectomy + endolaser. The participants will be followed for 3 years. The study will evaluate long-term visual acuity as well as differences in number of injections, procedures, and complications during follow-up (after completion of randomization treatment), and cost.

Start Date01 Mar 2025

Sponsor / Collaborator

Jaeb Center For Health Research Foundation, Inc.

[+2]

100 Clinical Results associated with Faricimab

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100 Translational Medicine associated with Faricimab

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100 Patents (Medical) associated with Faricimab

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272

Literatures (Medical) associated with Faricimab

01 Mar 2025·Retinal cases & brief reports

A CASE OF HYPERTENSIVE UVEITIS WITH INTRAVITREAL FARICIMAB

Article

Author: McAllister, Andrew ; Kitson, Samantha

Purpose::

The aim of this study was to report a novel case of hypertensive uveitis with intravitreal faricimab.

Methods::

This is a case report. A 69-year-old woman undergoing treatment of bilateral diabetic macular edema with intravitreal faricimab presented for routine review. Ophthalmic examination was performed including VA, intraocular pressure, gonioscopy, and slitlamp examination. Findings consistent with hypertensive uveitis prompted further infectious/inflammatory/infiltrative uveitis screen.

Results::

The patient developed hypertensive uveitis in the left eye (four weeks after the third injection) with an intraocular pressure of 42 mmHg. Slitlamp examination revealed fine keratic precipitates and mild anterior uveitis. Anterior chamber angle was open on gonioscopy, and there was no vitritis or vasculitis. At the review a week later, the patient had developed hypertensive uveitis in the right eye (six weeks after the fourth injection) with intraocular pressure of 35 mmHg. Slitlamp examination revealed fine keratic precipitates, open angles, and mild vitritis. There was no vasculitis. At both presentations, the patient had preserved VA with no significant visual symptoms. The hypertensive uveitis resolved in both eyes with a course of steroid and antihypertensive eye drops. The uveitis screen was negative apart from elevated urine protein (negative beta-2 microglobulin), which could be explained by known diabetes and hypertension.

Conclusion::

Hypertensive uveitis is a potential adverse reaction to intravitreal faricimab. This case highlights the importance of monitoring intraocular pressure in patients undergoing treatment with faricimab and emphasizes the need for reporting other cases in the community.

01 Mar 2025·AMERICAN JOURNAL OF OPHTHALMOLOGY

Comparison of Renal Adverse Events Between Intravitreal Anti–Vascular Endothelial Growth Factor Agents: A Meta-Analysis

Review

Author: Jhaveri, Aaditeya ; Balas, Michael ; Kertes, Peter J ; Huang, Ryan S ; Popovic, Marko M ; Muni, Rajeev H

PURPOSE:

To compare the risk of renal adverse events, particularly acute kidney injury (AKI), between intravitreal anti-vascular endothelial growth factor (anti-VEGF) agents.

DESIGN:

Meta-analysis.

METHODS:

A systematic literature search was conducted on Ovid Medline, Embase, and the Cochrane Library for randomized controlled trials (RCTs) published from January 2005 to February 2024 involving adult patients receiving anti-VEGF intravitreal injections for age-related macular degeneration, diabetic macular edema, and macular edema secondary to retinal vein occlusion. The primary outcome was the comparative risk of AKI between anti-VEGF agents and sham injections. Secondary outcomes involved other renal adverse events. Subgroup analyses were conducted by specific disease indications. A random-effects model was used for meta-analysis to estimate risk ratios (RRs) and their 95% confidence intervals, with a P value of <.05 representing statistical significance. Risk of bias was assessed using the Cochrane Risk of Bias 2 (ROB2) tool, and the certainty of evidence was evaluated through the Cochrane Grading of Recommendations, Assessment, Development and Evaluation (GRADE) framework.

RESULTS:

A total of 10,031 eyes from 11 RCTs were included. No significant differences were found in the risk of acute or chronic renal conditions, obstructive uropathies, neoplasia, or infectious processes between anti-VEGF agents and sham therapy. AKI was reported in 5.4% (n = 10/185) of patients treated with bevacizumab, 1.3% (n = 6/456) with sham, 1.0% (n = 48/4724) with aflibercept, 0.8% (n = 15/1929) with faricimab, 0.5% (n = 5/1098) with brolucizumab, and 0.3% (n = 5/1639) with ranibizumab. No significant differences in AKI risk were observed between any of the anti-VEGF agents and sham (P > .05 for all comparisons). However, there was an increased risk of patient-reported symptoms with 1.25 mg bevacizumab compared to 2 mg aflibercept (RR = 3.26, 95% CI = 1.07-9.93, P = .04), driven primarily by reports of hematuria: 4.3% (bevacizumab), 0.7% (sham), 0.2% (aflibercept), 0.1% (faricimab), and 0.1% (ranibizumab).

CONCLUSIONS:

US Food and Drug Administration (FDA)-approved intravitreal anti-VEGF agents do not significantly increase the risk of AKI compared to sham injections. Nevertheless, variations in patient-reported renal symptoms were observed across different anti-VEGF drugs. These variations were influenced primarily by differences in hematuria events, which may be a result of differential systemic absorption by these agents. These results underscore the importance of continuous monitoring and pharmacovigilance.

01 Mar 2025·RETINA-THE JOURNAL OF RETINAL AND VITREOUS DISEASES

REAL-WORLD LONG-TERM OUTCOMES OF INTRAVITREAL FARICIMAB IN PREVIOUSLY TREATED CHRONIC NEOVASCULAR AGE-RELATED MACULAR DEGENERATION

Article

Author: Brill, Daniel ; Sisk, Robert A. ; Leone, Adam ; Ambati, Naveen R.

Purpose::

To study the real-world outcomes of intravitreal faricimab (IVF) in long-standing neovascular age-related macular degeneration (nAMD) over a 1-year study period.

Methods::

Retrospective single-center cohort study of patients with previously treated nAMD receiving IVF with at least 12 months of follow-up. Main outcome measures include injection intervals, visual acuity (VA), and optical coherence tomography features.

Results::

A total of 263 eyes from 217 patients received 6.4 ± 2.3 IVF injections over 1 year. Injection interval increased after switching to IVF (5.9 ± 1.8 vs. 7.6 ± 2.4 weeks) (P < 0.01). There was no improvement in VA after switching to IVF at any time period (P > 0.15). Average CST decreased after the first IVF injection and was sustained for 1 year (313.7 ± 96.0 vs. 288.2 ± 80.6 µm) (P < 0.01). There was a statistically significant resolution of subretinal fluid but not IRF at all time points (40.8%–50.4%; P < 0.01). Persistent fluid after the first IVF injection was resolved in 34.4% (n = 45) by 1 year. IVF was discontinued in 31 eyes (11.8%), four (1.6%) that experienced intraocular inflammation.

Conclusion::

Long-standing nAMD eyes switched to IVF experienced a significant extension in injection interval, stable visual acuity, improvement in CST, and resolution of fluid on OCT in many patients over 1 year.

227

News (Medical) associated with Faricimab

05 Feb 2025

·www.echemi.com

Roche Reports CHF 60.5 Billion Revenue in 2024 with Focus on Oncology and R&D Adjustments

On January 30, Roche announced its financial results for 2024, reporting total revenue of CHF 60.495 billion (approximately $66.4 billion with a conversion rate of 1 CHF = 1.0981 USD), representing a 7% year-on-year growth. However, net income declined to CHF 9.187 billion (about $10.1 billion), a significant drop of 19%. The company invested CHF 13.042 billion (around $14.3 billion) in research and development, accounting for 21.6% of total revenue. Oncology continued to be the primary focus for R&D, along with substantial investments in immunology, cardiovascular, renal, and metabolic fields. Roche's pharmaceutical business generated CHF 46 billion (about $50.7 billion), marking an 8% increase, while the diagnostics division saw revenues of CHF 14.3 billion (approximately $15.7 billion), up 7%. The pharmaceutical segment remains the main source of Roche's profits. The company's pharmaceutical portfolio includes targeted therapies across five key areas: oncology, immunology, neuroscience, hematology, and ophthalmology. The ophthalmology sector showed remarkable growth in 2024, with sales reaching CHF 4 billion, reflecting a 44% increase. All other therapeutic areas also maintained positive growth trajectories. The drug Vabysmo (faricimab), launched in early 2022, continued to be a major growth driver, with sales of CHF 3.864 billion (about $4.243 billion) driven by increasing demand across all regions. Vabysmo is approved for three major retinal diseases, including wet age-related macular degeneration, diabetic macular edema, and retinal vein occlusion. Looking ahead, Roche's pipeline is robust, featuring 71 new molecular entities (NMEs) and a total of 122 projects. However, the financial report indicated that the company has reduced ten projects in Q4 2024, primarily in early development stages. Notably, Roche made significant cuts to its TIGIT antibody RG6058 pipeline, including two Phase III trials, two Phase II trials, and one Phase I trial. Several early-stage projects were also removed from the pipeline, including: A Phase I study of the FAP/4-1BB bispecific antibody RG7827 for solid tumors. A Phase I study of the HER2/CD3 bispecific antibody RG6194 for breast cancer. Additional Phase I projects targeting various solid tumors. The TIGIT monoclonal antibody RG6058, which had been the first TIGIT antibody to enter Phase III trials globally. Roche also removed two Phase II trials for the TIGIT antibody targeting metastatic head and neck squamous cell carcinoma and non-small cell lung cancer, alongside two Phase III trials. In recent updates, Roche faced setbacks with the TIGIT antibody in 2024. The SKYSCRAPER-06 study, which evaluated the combination of tiragolumab, Tecentriq, and chemotherapy against pembrolizumab and chemotherapy for locally advanced non-squamous NSCLC, did not meet its primary endpoint, showing a hazard ratio of 1.27 for progression-free survival. Currently, Roche's TIGIT antibody pipeline includes five ongoing Phase III studies, focusing on NSCLC, esophageal cancer, and liver cancer. Looking forward, Roche anticipates the potential for over seven new molecular entities with peak sales exceeding CHF 3 billion, along with four additional entities with peak sales between CHF 2 billion and 3 billion.

Phase 1Drug ApprovalFinancial StatementPhase 2Phase 3

04 Feb 2025

·www.fiercepharma.com

Roche gains label expansion for eye implant Susvimo to treat diabetic macular edema

Roche's Susvimo was originally approved in 2021 to treat patients with wet age-related macular degeneration. Now, it has been cleared for diabetic macular edema, the major cause of diabetic-related blindness. Seven months after the FDA signed off on a reintroduction of Roche’s eye implant Susvimo, the U.S. regulator has broadened its label as a treatment for diabetic macular edema (DME), which is the leading cause of diabetes-related blindness.The nod is the second indication for Susvimo, an alternative to regular eye injections that was originally approved to treat wet age-related macular degeneration in October 2021.Twelve months later, however, Susvimo was pulled because of manufacturing problems with the seal on the port delivery device. By July of last year, Roche had ironed out the issues and earned endorsement from the FDA to put it back on the market. Susvimo is the size of a grain of rice and is surgically implanted under the upper eyelid. The device provides a customized formulation of Lucentis (ranibizumab), which needs refilling just twice a year.“I am excited to offer Susvimo to my patients living with diabetic macular edema who want an option with longer intervals between treatments due to their busy personal and professional lives,” Jordan Graff, M.D., a vitreoretinal surgeon at a Barnet Dulaney Perkins Eye Center in Arizona, said in a release.The approval is based on results from a phase 3 study of more than 600 DME patients, which showed that Susvimo accomplished noninferior improvements in vision compared to monthly doses of Lucentis. Roche has yet to reveal sales figures for Susvimo. On its first go-round on the market, the treatment had started to gain acceptance from ophthalmologists. A few months before its recall, a Spherix survey revealed that a “large majority” of eye doctors acknowledged the therapy’s “superior duration of response” compared to Regeneron and Bayer’s stalwart Eylea. Since then, Roche’s Vabysmo—which was approved in 2022—has taken the market by storm, generating sales of 3.86 billion Swiss francs ($4.3 billion) in 2024, while sales of Eylea have fallen to $5.9 billion after peaking at $6.3 billion in 2022. As for Susvimo, Roche’s pharma chief Teresa Graham said on an earnings call last week that approximately 100 implants were completed in 2024.“In this stage of the launch, it’s all about getting new ophthalmologists exposure to Susvimo and trained on how to perform the implant and refill exchange procedures,” Graham added. “This is very much a story of going slow to ultimately go fast.”DME affects approximately 29 million adults in the world, including 750,000 people in the U.S., according to Roche. It occurs when damaged blood vessels in the retina leak into and cause swelling in the macula, which is the central area of the retina responsible for the sharp vision needed for reading and driving.

Phase 3Drug ApprovalClinical Result

04 Feb 2025

·endpts.com

After relaunch, Roche gets FDA approval for ocular implant in diabetic macular edema

Roche subsidiary Genentech announced Tuesday that it won FDA approval for its eye implant Susvimo to treat diabetic macular edema, a diabetes complication that causes swelling and blurred vision. Genentech relaunched Susvimo last year for wet AMD, another eye condition that leads to blurry vision, after pulling it from the market in 2022 over manufacturing problems. It has since been seeking to expand the eye implant’s uses. Susvimo is a surgical implant that can be refilled every six months with the VEGF antibody ranibizumab, which Genentech and Novartis market as Lucentis. The list price for Susvimo is $16,950 the first year, with the two refills per year priced at $16,000. That compares with a $14,040 yearly list price for the version of Lucentis in diabetic macular edema. Lucentis sales have been falling since biosimilars came on the market in 2022. Roche reported that Lucentis generated CHF 144 million ($159 million) in sales last year, a 68% decrease compared with 2023. The pharma also markets the anti-VEGF drug Vabysmo, which may be used with less frequent dosing. In a Phase 3 study called Pagoda, people with diabetic macular edema who received Susvimo with refills every six months saw similar improvements in vision with those who received monthly ranibizumab injections. In a separate study, Genentech also studied Susvimo in diabetic retinopathy, and said in July that the FDA had accepted its application to expand Susvimo’s label in both diabetic retinopathy and diabetic macular edema. The FDA’s review for diabetic retinopathy is currently ongoing, the company told Endpoints News . Susvimo was first approved in 2021, but Genentech withdrew the treatment from markets in 2022 after a recall related to a seal on the delivery device failing after repeat dosing.

Phase 3Drug ApprovalClinical Result

100 Deals associated with Faricimab

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External Link

KEGG	Wiki	ATC	Drug Bank
D11516	Faricimab	-	DB15303

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Retinal Vein Occlusion	Japan	Chugai Pharmaceutical Co., Ltd.	26 Mar 2024
Retinal vein occlusion-related macular edema	Australia	Roche Products Pty Ltd.	08 Aug 2022
Age Related Macular Degeneration	Japan	Chugai Pharmaceutical Co., Ltd.	28 Mar 2022
Choroidal Neovascularization	Japan	Chugai Pharmaceutical Co., Ltd.	28 Mar 2022
Dystrophy, Macular	Japan	Chugai Pharmaceutical Co., Ltd.	28 Mar 2022
Diabetic macular oedema	United States	Genentech, Inc.	28 Jan 2022
Wet age-related macular degeneration	United States	Genentech, Inc.	28 Jan 2022

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Proliferative retinopathy with diabetes mellitus	Phase 3	-	Genentech, Inc.	01 Mar 2025
Myopia, Degenerative	Phase 3	United States	-	06 Mar 2024
Myopia, Degenerative	Phase 3	China	-	06 Mar 2024
Myopia, Degenerative	Phase 3	Australia	-	06 Mar 2024
Myopia, Degenerative	Phase 3	France	-	06 Mar 2024
Myopia, Degenerative	Phase 3	Germany	-	06 Mar 2024
Myopia, Degenerative	Phase 3	Hong Kong	-	06 Mar 2024
Myopia, Degenerative	Phase 3	Italy	-	06 Mar 2024
Myopia, Degenerative	Phase 3	Poland	-	06 Mar 2024
Myopia, Degenerative	Phase 3	Singapore	-	06 Mar 2024

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


CTR20222310 (SALWEEN, Company_Website) Manual	Phase 3	Polypoidal choroidal vasculopathy	135	Vabysmo (faricimab)	mmpjfpeefl(djqopbxjkp) = rnzgpyhhdx axpbcxkmmn (rndhlepcae ) View more	Positive	27 Nov 2024
NCT04432831 (Rhone-X, CTgov)	Phase 3	Diabetic macular oedema	1,479	Faricimab PTI+Faricimab Q8W (Faricimab PTI (Prior Faricimab Q8W))	nxxbtcgcsk(aymjfwhfen) = eyekkxjyiv pqdaanjkkc (zeirmedqdv, dlnnxohazr - iuzckmzxmy) View more	-	30 Oct 2024
NCT04432831 (Rhone-X, CTgov)	Phase 3	Diabetic macular oedema	1,479	Faricimab PTI+Faricimab (Faricimab PTI (Prior Faricimab PTI))	nxxbtcgcsk(aymjfwhfen) = yusugnklse pqdaanjkkc (zeirmedqdv, uujjwnmkiu - cbujmubuda) View more	-	30 Oct 2024
NCT05224102 (ELEVATUM, GlobeNewswire) Manual	Phase 4	Diabetic macular oedema	124	Vabysmo (from racial and ethnic groups that are often underrepresented)	kmdsrgdqol(jbdqxcdtyt) = ajuhezgwhd wqxdinzgip (wqtenrssfz ) View more	Positive	18 Oct 2024
NCT05224102 (ELEVATUM, GlobeNewswire) Manual	Phase 4	Diabetic macular oedema	124	Vabysmo (Hispanic and Latino participants)	kmdsrgdqol(jbdqxcdtyt) = jupukmxnrm wqxdinzgip (wqtenrssfz )	Positive	18 Oct 2024
EURETINA2024 Manual	Not Applicable	Diabetic macular oedema	23	Faricimab	rlaclmgicb(dgxqzrpkgi) = None of the patients had adverse events with faricimab vtbddgtgmr (rkpimghaaz ) View more	Negative	19 Sep 2024
EURETINA2024 Manual	Not Applicable	Panuveitis	3	Faricimabeal Faricimab	oaksoronam(yweiulcete) = ziiikdfzzl lejpzrsarq (mmrkgqnjic )	Positive	19 Sep 2024
FARETINA-AMD (EURETINA2024) Manual	Not Applicable	Wet age-related macular degeneration	26,278	Faricimab	kypgjdjkgx(xkwcpzyfam) = lvcrzdmotl xrcsigkcjc (utxksgtftl, 16.4) View more	Positive	19 Sep 2024
FARETINA-AMD (EURETINA2024) Manual	Not Applicable	Wet age-related macular degeneration	26,278	Faricimabpt	kypgjdjkgx(xkwcpzyfam) = dfutysdnxn xrcsigkcjc (utxksgtftl, 12.0) View more	Positive	19 Sep 2024
NCT04597918 (ALTIMETER, EURETINA2024) Manual	Phase 2	Diabetic macular oedema First line	99	Faricimab 6 mg	hrmqvclvvj(cfvcofdwqg) = cfdfmwccza pxtbmojoyn (nsmernmpko, 7.5 - 10.9) View more	Positive	19 Sep 2024
EURETINA2024 Manual	Not Applicable	Wet age-related macular degeneration	26	FaricimabFaricimab	icvdizhjty(ozkgefpsqk) = xryljvwrdn gumtggniou (lokqtfvisf ) View more	Positive	19 Sep 2024
EURETINA2024 Manual	Not Applicable	Diabetic macular oedema \| Wet age-related macular degeneration	127	faricimab (Treatment-naïve neovascular age-related macular degeneration (nAMD))	ktnljqpvox(sdkmivzhcy) = dhkywqqhal heqhyzbjtu (cdpgaypcql )	Positive	19 Sep 2024
EURETINA2024 Manual	Not Applicable		127	faricimab (Previously-treated neovascular age-related macular degeneration (nAMD))	ktnljqpvox(sdkmivzhcy) = tlotaxtzpx heqhyzbjtu (cdpgaypcql )	Positive	19 Sep 2024
EURETINA2024 Manual	Not Applicable	Wet age-related macular degeneration	203	Faricimab	moddrspnvv(aptdpwkzky) = cxwrceelop danfqtsrgj (fzdmppwjgr )	Positive	19 Sep 2024