Faricimab

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Faricimab
Antibodyigg.png
Monoclonal antibody
TypeWhole antibody
SourceHumanized
TargetVEGF-A, angiopoietin 2[1]
Clinical data
Trade namesVabysmo
Other namesRO6867461; RG7716; faricimab-svoa
License data
Routes of
administration
Intravitreal
ATC code
  • None
Legal status
Legal status
Identifiers
CAS Number
DrugBank
UNII
KEGG
Chemical and physical data
FormulaC6506H9968N1724O1026S45
Molar mass130197.05 g·mol−1

Faricimab, sold under the brand name Vabysmo, is a monoclonal antibody used for the treatment of neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME).[1][2] Faricimab is the first bispecific monoclonal antibody,[3] to target both vascular endothelial growth factor (VEGF),[1] and angiopoietin 2 (Ang-2) inhibitor.[1] By targeting these pathways, faricimab stabilizes blood vessels in the retina.[3] It is given by intravitreal injection (injection into the eye) by an ophthalmologist.[1]

Faricimab was developed by Roche. Faricimab completed Phase III trials[4] and was approved for medical use in the United States in January 2022.[2][5]

Medical uses

Faricimab is indicated for treatment of neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME).[1]

Adverse effects

The most common adverse reaction reported in people receiving faricimab include conjunctival bleeding.[1]

Contraindications

Contraindications to injection of faricimab include active infection in or around the eye, active inflammation in the eye (uveitis), and prior allergic reactions to receiving the drug (hypersensitivity).[1]

Special populations

Pregnancy

There are no adequate and well-controlled studies of faricimab administration in pregnant women.[1]

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.[1]

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.[1]

Pharmacology

Faricimab is a 150kDa-sized bispecific antibody whose molecular structure allows a high affinity bond to both vascular endothelial growth factor A (VEGF-A) and Angiopoietin (Ang-2).[3] By blocking the action of these two growth factors, faricimab decreases migration and replication of endothelial cells allowing for stabilization of vascular structures, thereby decreasing vascular leakage.[4][6][7] Faricimab has shown improved and sustained efficacy in comparison to agents that only target the VEGF pathway.[4]

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 barrier breakdown in blood vessels.[4] 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.[4]

Research

Neovascular age-related macular degeneration (nAMD)

Two phase II trials evaluated faricimab's efficacy and safety in comparison to ranibizumab and showed that faricimab received every 16 weeks and every 12 weeks was comparable to ranibizumab received every 4 weeks in visual acuity and imaging outcomes.[4] In 2019, two phase III multi-center randomized studies were initiated on 1200 participants with neovascular age related macular degeneration (nAMD) to evaluate faricimab's safety, efficacy, and durability against aflibercept.[4] Participants were randomized to receive faricimab every 16 weeks or aflibercept every eight weeks. 80% of faricimab-treated participants were able to go three months (12 weeks) or longer between treatments during the first year with comparable visual outcomes and treatment effects on their disease as aflibercept, which is typically given every 8 weeks.[2][7]

Diabetic macular edema (DME)

One phase II trial evaluated faricimab's efficacy and safety in comparison to ranibizumab and showed clinically meaningful and statistically significant improvements in visual acuity.[4][8] Two Phase III multi-center randomized studies were completed on 1,891 diabetic participants with diabetic macular edema (DME)[4] By 1 year, >70% of participants receiving faricimab had their treatment intervals extended to every 3 months (12 weeks) or longer.[9]

Society and culture

Faricimab is the first injectable ophthalmic drug to achieve up to 16 weeks between treatments.[10] There is high demand for extended treatment options such as faricimab as they decrease treatment burden on participants who can receive injections as frequently as monthly with current standard of care treatments.[4] The treatment burden for conditions such as diabetic macular edema (DME) causes large gaps in outcomes between randomized clinical trials where patient conditions are optimal and controlled and daily clinical practice where patients may not be able to access their injection appointments on time.[6] Therapeutics like faricimab hope to reduce this disparity by making optimal treatment achievable for patients through more feasible injection schedules.[6]

Names

Faricimab is the International Nonproprietary Name (INN).[11] Faricimab was formerly named RG7716.[12]

References

  1. ^ a b c d e f g h i j k l "Vabysmo- faricimab injection, solution". DailyMed. 7 February 2022. Retrieved 20 February 2022.
  2. ^ a b c "FDA approves Roche's Vabysmo, the first bispecific antibody for the eye, to treat two leading causes of vision loss". Roche (Press release). 31 January 2022. Retrieved 31 January 2022.
  3. ^ a b c Nicolò M, Ferro Desideri L, Vagge A, Traverso CE (March 2021). "Faricimab: an investigational agent targeting the Tie-2/angiopoietin pathway and VEGF-A for the treatment of retinal diseases". Expert Opinion on Investigational Drugs. 30 (3): 193–200. doi:10.1080/13543784.2021.1879791. PMID 33471572. S2CID 231665201.
  4. ^ a b c d e f g h i j Khan M, Aziz AA, Shafi NA, Abbas T, Khanani AM (August 2020). "Targeting Angiopoietin in Retinal Vascular Diseases: A Literature Review and Summary of Clinical Trials Involving Faricimab". Cells. 9 (8): 1869. doi:10.3390/cells9081869. PMC 7464130. PMID 32785136.
  5. ^ "FDA approves faricimab for treatment of wet AMD, DME". Ophthalmology Times. 28 January 2022.
  6. ^ a b c Iglicki, Matias; González, David Pérez; Loewenstein, Anat; Zur, Dinah (9 August 2021). "Next-generation anti-VEGF agents for diabetic macular oedema". Eye. 36 (2): 273–277. doi:10.1038/s41433-021-01722-8. ISSN 0950-222X. PMC 8807622. PMID 34373607.
  7. ^ a b Fenner, Beau J.; Cheung, Chui Ming Gemmy; Sim, Shaun S.; Lee, Won Ki; Staurenghi, Giovanni; Lai, Timothy Y. Y.; Ruamviboonsuk, Paisan; Kokame, Gregg; Yanagi, Yasuo; Teo, Kelvin Y. C. (14 July 2021). "Evolving treatment paradigms for PCV". Eye. 36 (2): 257–265. doi:10.1038/s41433-021-01688-7. ISSN 0950-222X. PMC 8807588. PMID 34262165.
  8. ^ "Phase II data support potential for Roche's novel anti-VEGF/anti-angiopoietin-2 bispecific antibody, RG7716, for people with diabetic macular edema". Roche (Press release). Retrieved 17 February 2022.
  9. ^ Sharma A, Kumar N, Parachuri N, Karanam D, Kuppermann BD, Bandello F, Regillo CD (October 2021). "Faricimab phase 3 DME trial significance of personalized treatment intervals (PTI) regime for future DME trials". Eye (Lond). 36 (4): 679–680. doi:10.1038/s41433-021-01831-4. PMC 8956679. PMID 34718339. S2CID 240157515.
  10. ^ Sharma A, Kumar N, Kuppermann BD, Bandello F, Loewenstein A (May 2020). "Faricimab: expanding horizon beyond VEGF". Eye (London, England). 34 (5): 802–804. doi:10.1038/s41433-019-0670-1. ISSN 1476-5454. PMC 7182558. PMID 31695160.
  11. ^ World Health Organization (2018). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 80". WHO Drug Information. 32 (3). hdl:10665/330907.
  12. ^ Kaplon, Hélène; Chenoweth, Alicia; Crescioli, Silvia; Reichert, Janice M. (January 2022). "Antibodies to watch in 2022". mAbs. 14 (1): 2014296. doi:10.1080/19420862.2021.2014296. ISSN 1942-0870. PMC 8765076. PMID 35030985.

External links

  • "Faricimab". Drug Information Portal. U.S. National Library of Medicine.
  • Clinical trial number NCT03622580 for "A Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Participants With Diabetic Macular Edema (YOSEMITE)" at ClinicalTrials.gov
  • Clinical trial number NCT03622593 for "A Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Participants With Diabetic Macular Edema (RHINE)" at ClinicalTrials.gov
  • Clinical trial number NCT03823287 for "A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Neovascular Age-Related Macular Degeneration (TENAYA)" at ClinicalTrials.gov
  • Clinical trial number NCT03823300 for "A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Neovascular Age-Related Macular Degeneration (LUCERNE)" at ClinicalTrials.gov