Faricimab, sold under the brand name Vabysmo ( ), is a

monoclonal antibody A monoclonal antibody (mAb, more rarely called moAb) is an antibody produced from a cell lineage made by cloning a unique white blood cell. All subsequent antibodies derived this way trace back to a unique parent cell. Monoclonal antibodie ...

used for the treatment of neovascular

age-related macular degeneration Macular degeneration, also known as age-related macular degeneration (AMD or ARMD), is a medical condition which may result in blurred or no vision in the center of the visual field. Early on there are often no symptoms. Some people experien ...

(nAMD) and

diabetic macular edema Diabetic retinopathy (also known as diabetic eye disease) is a medical condition in which damage occurs to the retina due to diabetes. It is a leading cause of blindness in developed countries and one of the lead causes of sight loss in the wor ...

(DME). Faricimab is the first

bispecific monoclonal antibody A bispecific monoclonal antibody (BsMAb, BsAb) is an artificial protein that can simultaneously bind to two different types of antigen or two different epitopes on the same antigen. Naturally occurring antibodies typically only target one antigen. ...

to target both

vascular endothelial growth factor Vascular endothelial growth factor (VEGF, ), originally known as vascular permeability factor (VPF), is a signal protein produced by many cells that stimulates the formation of blood vessels. To be specific, VEGF is a sub-family of growth factors ...

(VEGF) and

angiopoietin 2 Angiopoietin-2 is a protein that in humans is encoded by the ''ANGPT2'' gene. Naturally occurring antagonist for both ANGPT1 and TIE2; expressed only at the sites of vascular remodeling; similar to angiopoietin-1 Function * See Angiopoietin#C ...

(Ang-2). By targeting these pathways, faricimab stabilizes blood vessels in the

retina The retina (; or retinas) is the innermost, photosensitivity, light-sensitive layer of tissue (biology), tissue of the eye of most vertebrates and some Mollusca, molluscs. The optics of the eye create a focus (optics), focused two-dimensional ...

. It is given by

intravitreal injection Intravitreal administration is a route of administration of a drug, or other substance, in which the substance is delivered into the vitreous humor of the eye. "Intravitreal" literally means "inside an eye". Intravitreal injections were first intr ...

(injection into the eye) by an

ophthalmologist Ophthalmology (, ) is the branch of medicine that deals with the diagnosis, treatment, and surgery of eye diseases and disorders. An ophthalmologist is a physician who undergoes subspecialty training in medical and surgical eye care. Following a ...

. Faricimab was developed by

Roche F. Hoffmann-La Roche AG, commonly known as Roche (), is a Switzerland, Swiss multinational corporation, multinational holding healthcare company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics. Its holding company, ...

in Penzberg
Roche Innovation Center Munich
. Faricimab was approved for medical use in the United States in January 2022, and in the European Union in September 2022.

Medical uses

Faricimab is

indicated In medicine, an indication is a valid reason to use a certain test, medication, procedure, or surgery. There can be multiple indications to use a procedure or medication. An indication can commonly be confused with the term diagnosis. A diagnosis ...

for treatment of neovascular

(nAMD) and

(DME).

Adverse effects

The most common adverse reaction reported in people receiving faricimab include

conjunctiva In the anatomy of the eye, the conjunctiva (: conjunctivae) is a thin mucous membrane that lines the inside of the eyelids and covers the sclera (the white of the eye). It is composed of non-keratinized, stratified squamous epithelium with gobl ...

l bleeding.

Contraindications

Contraindications to injection of faricimab include active

infection An infection is the invasion of tissue (biology), tissues by pathogens, their multiplication, and the reaction of host (biology), host tissues to the infectious agent and the toxins they produce. An infectious disease, also known as a transmis ...

in or around the eye, active inflammation in the eye (

uveitis Uveitis () is inflammation of the uvea, the pigmented layer of the eye between the inner retina and the outer fibrous layer composed of the sclera and cornea. The uvea consists of the middle layer of pigmented vascular structures of the eye and ...

), and prior allergic reactions to receiving the drug (

hypersensitivity Hypersensitivity (also called hypersensitivity reaction or intolerance) is an abnormal physiological condition in which there is an undesirable and adverse immune response to an antigen. It is an abnormality in the immune system that causes Imm ...

Special populations

Pregnancy

There are no adequate and well-controlled studies of faricimab administration in

pregnant Pregnancy is the time during which one or more offspring gestation, gestates inside a woman's uterus. A multiple birth, multiple pregnancy involves more than one offspring, such as with twins. Conception (biology), Conception usually occurs ...

women.

Breast feeding

There is no information regarding faricimab accumulation in breast milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production. However, the drug company states that many drugs are transferred in human milk with the potential for absorption and adverse reactions in the breastfed child.

Fertility

No studies on the effects of faricimab on human fertility have been conducted and it is not known whether faricimab can affect reproduction. Based on its mechanism of action, treatment with may pose a risk to reproductive capacity.

Pharmacology

Faricimab is a 150kDa-sized bispecific antibody whose molecular structure allows a high affinity bond to both

vascular endothelial growth factor A Vascular endothelial growth factor A (VEGF-A) is a protein that in humans is encoded by the ''VEGFA'' gene. Function This gene is a member of the platelet-derived growth factor (PDGF)/vascular endothelial growth factor (VEGF) family and encod ...

(VEGF-A) and

Angiopoietin Angiopoietin is part of a family of vascular growth factors that play a role in embryonic and postnatal angiogenesis. Angiopoietin signaling most directly corresponds with angiogenesis, the process by which new arteries and veins form from pree ...

(Ang-2). By blocking the action of these two growth factors, faricimab decreases migration and replication of

endothelial cells The endothelium (: endothelia) is a single layer of squamous endothelial cells that line the interior surface of blood vessels and lymphatic vessels. The endothelium forms an interface between circulating blood or lymph in the lumen and the res ...

allowing for stabilization of vascular structures, thereby decreasing vascular leakage. Faricimab has shown improved and sustained efficacy in comparison to agents that only target the

VEGF pathway Vascular endothelial growth factor (VEGF, ), originally known as vascular permeability factor (VPF), is a signal protein produced by many cells that stimulates the formation of blood vessels. To be specific, VEGF is a sub-family of growth factors ...

History

In 2016, pre-clinical studies looking at the mechanism of action behind faricimab showed that by blocking Ang-2, one of the drug's targets, there was decreased

endothelial The endothelium (: endothelia) is a single layer of squamous endothelial cells that line the interior surface of blood vessels and lymphatic vessels. The endothelium forms an interface between circulating blood or lymph in the lumen and the res ...

barrier breakdown in blood vessels. In 2017, phase I studies in neovascular age related macular degeneration (nAMD) showed that the drug was safe to use in people and well tolerated.

Society and culture

Legal status

On 21 July 2022, the

Committee for Medicinal Products for Human Use The Committee for Medicinal Products for Human Use (CHMP), formerly known as the Committee for Proprietary Medicinal Products (CPMP), is the European Medicines Agency's committee responsible for elaborating the agency's opinions on all issues regar ...

(CHMP) of the

European Medicines Agency The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of pharmaceutical products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products ...

(EMA) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Vabysmo, intended for the treatment of neovascular age-related macular degeneration (nAMD) and diabetic macular oedema (DME). The applicant for this medicinal product is Roche Registration GmbH. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged. Faricimab was approved for medical use in the European Union in September 2022.

Names

Faricimab is the International Nonproprietary Name (INN). Faricimab was formerly named RG7716.

Research

Neovascular age-related macular degeneration

Two

phase II trials The phases of clinical research are the stages in which scientists conduct experiments with a health intervention to obtain sufficient evidence for a process considered effective as a medical treatment. For drug development, the clinical phases ...

evaluated faricimab's efficacy and safety in comparison to

ranibizumab Ranibizumab, sold under the brand name Lucentis among others, is a monoclonal antibody fragment (Fab) created from the same parent mouse antibody as bevacizumab. It is an anti-angiogenic that is approved to treat the "wet" type of age-related ...

and showed that faricimab received every 16 weeks and every twelve weeks was comparable to

received every four weeks in visual acuity and imaging outcomes. In 2019, two phase III multi-center randomized studies TENAYA and LUCERNE were initiated on 1,200 participants with neovascular age related macular degeneration (nAMD) to evaluate faricimab's safety, efficacy, and durability against

aflibercept Aflibercept, sold under the brand names Eylea and Zaltrap among others, is a medication used to treat wet macular degeneration and metastatic colorectal cancer. It was developed by Regeneron Pharmaceuticals. It is an inhibitor of vascular en ...

. Both studies reached its primary endpoints and showed that faricimab given at up to every 16 weeks was non-inferior to aflibercept administered every 8 weeks. Faricimab demonstrated its potential to extend the time between intravitreal injections in nAMD patients.

Diabetic macular edema

One

phase II trial The phases of clinical research are the stages in which scientists conduct experiments with a health intervention to obtain sufficient evidence for a process considered effective as a medical treatment. For drug development, the clinical phases ...

evaluated faricimab's efficacy and safety in comparison to

and showed clinically meaningful and statistically significant improvements in

visual acuity Visual acuity (VA) commonly refers to the clarity of visual perception, vision, but technically rates an animal's ability to recognize small details with precision. Visual acuity depends on optical and neural factors. Optical factors of the eye ...

. Two phase III multi-center randomized studies were completed on 1,891 diabetic participants with diabetic macular edema (DME).

Branch and central retinal vein occlusion macular edema

In two phase III trials, faricimab met the primary endpoint of non-inferior visual acuity gains when compared with

in 553 participants with macular edema due to

branch retinal vein occlusion Branch retinal vein occlusion is a common retinal vascular disease of the elderly. It is caused by the occlusion of one of the branches of central retinal vein. Signs and symptoms Patients with branch retinal vein occlusion usually have a sudden ...

(BRVO) and

central retinal vein occlusion Central retinal vein occlusion, also CRVO, is when the central retinal vein becomes occluded, usually through thrombosis. The central retinal vein is the venous equivalent of the central retinal artery and both may become occluded. Since the cent ...

(CRVO) in the BALATON and COMINO studies.

References

External links

* * * * {{Portal bar , Medicine Angiogenesis inhibitors Drugs developed by Genentech Drugs developed by Hoffmann-La Roche Monoclonal antibodies Ophthalmology drugs