The first registered bispecific antibody for the eye to treat neovascular or ‘wet’ age-related macular degeneration (nAMD) and diabetic macular oedema (DMO)1 has been approved by the Australian Therapeutic Goods Administration (TGA).
nAMD and DMO are leading causes of vision loss worldwide and present a growing health issue as populations age and experience increased prevalence of diabetes.2,3,4
nAMD, a disease of the macula which affects sharp, central vision, is a leading cause of vision loss in people over 60.4,5,6 It is estimated that approximately one in seven Australians over the age of 50 years have some evidence of AMD,7 with nAMD impacting about 10 – 15% of those8 – equating to approximately 128,000 – 192,000 Australians living with nAMD.9
DMO is an advanced form of diabetic retinopathy (DR) and the major cause of central vision loss among patients with DR,10,11 impacting an estimated 40,000 Australians.12,13 Both nAMD and DMO can limit a person’s ability to read, drive, see pictures or even recognise faces.5,14
Vabysmo (faricimab by Roche), the is the first registered bispecific antibody approved for the eye in Australia.1 Vabysmo specifically recognises and blocks the activity of proteins known as angiopoietin-2 and vascular endothelial growth factor A.15 Vabysmo is administered by four initial four-weekly eye injections. Thereafter, the frequency of the ongoing injections will be determined by the treating physician and may be up to 16 weeks apart based on the patient’s anatomic and vision outcomes.15
“Both neovascular AMD and diabetic macular oedema can have physical, emotional and economic consequences for patients and their families. As the conditions progress, people living with nAMD or DMO may become increasingly dependent on their loved ones for everyday activities as well as have their professional and social lives negatively affected,” said Prof Paul Mitchell, Director of the Centre For Vision Research at the Westmead Institute for Medical Research.
Richard Woodfield, Country Medical Director, Roche Australia added, “We are delighted the Therapeutic Goods Administration has registered Vabysmo for people living with either nAMD or DMO in Australia. This registration marks a significant step in our commitment to people living with retinal conditions and we will continue to work collaboratively with the Government through the required next steps to ensure eligible Australians are able to access this additional treatment option as soon as possible.”
Building on its heritage of developing new medicines (oncology, immunology, infectious diseases, and neurology), Roche is now taking on the leading causes of blindness and visual impairment,2,3,4 addressing the critical needs of people living with debilitating eye diseases. The company’s investment in ophthalmology is centred on designing solutions tailored to the biology of the disease.
Minimum Product Information
Vabysmo (faricimab)
This medicinal product is subject to additional monitoring in Australia. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events at https://www.tga.gov.au/reporting-problems.
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Indications: Treatment of neovascular (wet) age-related macular degeneration (nAMD). Treatment of diabetic macular oedema (DMO). Dosage and Administration: nAMD: 6 mg (0.05 mL) administered by intravitreal injection every four weeks for the first 4 doses followed by an assessment of visual and/or anatomic outcomes to support treatment individualisation. Based on the assessment, dosing every 16 weeks (patients without disease activity) or every 8 or 12 weeks (patients with disease activity) can be considered. Ongoing monitoring to support dosing is recommended. DMO: 6mg (0.05 mL) administered by intravitreal injection every four weeks for the first four doses. Thereafter treatment may be individualised using a treat and extend approach following an assessment of the patient’s anatomic and/or visual outcomes, following which the dosing interval may remain at every four weeks, or may be extended in four week increments every 16 weeks. Ongoing monitoring to support dosing is recommended. Refer to full Product Information (PI) for information on dose and administration of Vabysmo. Contraindications: Known hypersensitivity to faricimab or to any of the excipients, ocular or periocular infections, active intraocular inflammation. Precautions: Intravitreal injection-related reactions: Use aseptic injection techniques when administering Vabysmo. Patients should be instructed to report any symptoms suggestive of endophthalmitis, intraocular inflammation, rhegmatogenous retinal detachment and retinal tear, to permit prompt and appropriate management. Intraocular pressure increase: Transient increases in intraocular pressure (IOP) have been seen within 60 minutes of intravitreal injections. Do not inject Vabysmo while the IOP is ≥ 30 mmHg. Both the IOP and perfusion of the optic nerve head and/or vision must be monitored and managed appropriately. Systemic effects: Systemic adverse events including arterial thromboembolic events have been reported following intravitreal injection of vascular endothelial growth factor (VEGF) inhibitors. Bilateral Treatment: The safety and efficacy of Vabysmo administered in both eyes concurrently have not been studied. Concomitant use of other anti-VEGF: No data is available on the concomitant use of Vabysmo with anti-VEGF medicinal products in the same eye. Withholding treatment: Treatment should be withheld in patients with: • Rhegmatogenous retinal detachment, stage 3 or 4 macular holes, retinal break. • Treatment related decrease in Best Corrected Visual Acuity (BCVA) of ≥ 30 letters compared with the last assessment of visual acuity. • Performed or planned intraocular surgery within the previous or next 28 days at the physician’s discretion. Retinal pigment epithelial tear (nAMD only): Risk factors associated with the development of a retinal pigment epithelial tear include a large and/or high pigment epithelial detachment. When initiating Vabysmo therapy, caution should be used in patients with these risk factors. Populations with limited data: In nAMD clinical trials, there were limited data in patients with the total lesion size > 9 disc areas on fundus fluorescein angiography (FFA). There is only limited experience in the treatment of DMO patients with a HbA1c over 10%, patients with high-risk proliferative diabetic retinopathy (DR), or nAMD and DMO patients with active systemic infections and no experience in diabetic patients with uncontrolled hypertension. Pregnancy Category D: Vabysmo should not be used unless the potential benefit to the patient outweighs the potential risk to the fetus. Women of childbearing potential should use contraception during treatment and for at least 3 months following the last dose of Vabysmo. Lactation: It is not known whether faricimab is excreted in human breast milk. Adverse Effects: nAMD and DMO: cataract, conjunctival haemorrhage, intraocular pressure increased, vitreous floaters, eye pain, increased lacrimation. nAMD only: retinal pigment epithelial tear.
Please review the Product Information (PI) before prescribing. Full PI is available from Roche Products Pty Limited (www.roche-australia.com/en_au/products/pharmaceuticals.html). Medical enquiries: 1800 233 950
Reimbursement Status: VABYSMO (faricimab) is not listed on the PBS
For more information, please visit www.roche-australia.com.
References
1. Australian Therapeutic Goods Administration. Public Summary. [Internet] Available from: https://www.ebs.tga.gov.au/servlet/xmlmillr6?dbid=ebs/PublicHTML/pdfStore.nsf&docid=369935&agid=(PrintDetailsPublic)&actionid=1 (last accessed 9 August 2022).
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3. Liu E et al. Diabetic macular oedema: clinical risk factors and emerging genetic influences. Clin Exp Optom. 2017;100:569–76.
4. Wong WL et al. Global prevalence of age-related macular degeneration and disease burden projection for 2020 and 2040: a systematic review and meta-analysis. Lancet Glob Health. 2014;2:106–16.
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11. Yoon, YH et al. Natural history of diabetic macular edema and factors predicting outcomes in sham-treated patients (MEAD study). Graefes Arch Clin Exp Ophthalmol. 2019; 257(12): 2639-2653.
12. Australian Bureau of Statistics. 2022 Health: Census. [Online] Available from: https://www.abs.gov.au/statistics/health/health-conditions-and-risks/health-census/2021/Health%20data%20summary.xlsx (last accessed 29 July 2022).
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14. Retina Risk. What causes diabetic macula edema. [Internet; cited June 2021]. Available from: https://www.retinarisk.com/blog/what-causes-diabetic-macular-edema/ (last accessed 29 July 2022).
15. Roche. Vabysmo Consumer Medicines Information
16. Macular Disease Foundation Australia (MDFA). What is AMD? Available from: https://www.mdfoundation.com.au/about-macular-disease/age-related-macular-degeneration/what-is-amd/#:~:text=Wet%20(neovascular)%20age%2Drelated,and%20blood%20under%20the%20retina (last accessed 29 July 2022).
17. Macular Disease Foundation Australia (MDFA). Stages of AMD. Available from: https://www.mdfoundation.com.au/about-macular-disease/age-related-macular-degeneration/stages-of-amd/#late-AMD (last accessed 29 July 2022).
18. Little K et al. Myofibroblasts in macular fibrosis secondary to neovascular age-related macular degeneration-the potential sources and molecular cues for their recruitment and activation. EBioMedicine. 2018;38:283-91.
19. Pennington KL et al. Epidemiology of age-related macular degeneration (AMD): associations with cardiovascular disease phenotypes and lipid factors. Eye and vision. 2016;3:1-20.
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