European Commission authorizes faricimab for nAMD and DME
Roche today announced that the European Commission (EC) has approved faricimab (Vabysmo) for the treatment of neovascular or “wet” age-related macular degeneration (AMD) and visual impairment due to edema diabetic macular (DMO).
According to the company’s press release, these retinal conditions are two of the leading causes of vision loss worldwide, affecting more than 40 million people. 1,2,3,4
Ramin Tadayoni, MD, PhD, Head of Ophthalmology, Lariboisière, Saint-Louis and Rothschild Hospitals, Paris, France, and President-elect of the European Society of Retina Specialists (EURETINA), noted in a press release that a number of people with nAMD and DME struggle to keep up with the monthly eye injections and doctor visits often associated with today’s standard of care, and unfortunately their vision may suffer due to a insufficient treatment.
“For people in Europe living with these conditions, today’s approval offers the first new mechanism for action in over a decade; one that could improve and protect their vision with fewer injections over time,” he said in the statement.
According to the press release, faricimab is the only approved injectable eye medication in Europe with phase III studies supporting treatment at intervals of up to four months for people with nAMD and DME.5,6,7
Today’s approval is based on the results of four Phase III studies in two indications, involving 3,220 patients: TENAYA and LUCERNE in AMD in the first year, and YOSEMITE and RHINE in DME through two years. The studies showed that people treated with faricimab, given at intervals of up to four months, had similar vision gains and anatomical improvements compared with aflibercept given every two months.6,7,8 Taken together, the data from the four two-year studies showed that more than 60% of people treated with faricimab were able to extend treatment to every four months, while improving and maintaining their vision. Additionally, up to two years, people with AMD and DME treated with faricimab received 33% (10 versus 15) and 21% (11 versus 14) fewer median injections, respectively, compared to to aflibercept.6.9
Faricimab, a bispecific antibody, is specifically designed to target and inhibit two disease pathways, linked to a number of vision-threatening retinal conditions, by neutralizing angiopoietin-2 (Ang-2) and vascular endothelial growth factor -A (VEGF-A), to restore vascular stability. By independently blocking both pathways involving Ang-2 and VEGF-A, faricimab is designed to stabilize blood vessels and thereby reduce inflammation, leakage and abnormal vessel growth (neovascularization) more than inhibiting VEGF- Alone.7 This long-lasting stabilization of blood vessels can improve disease control, vision, and anatomic outcomes for longer.7.8
Faricimab is now approved in the European Union and nine other countries around the world, including the United States, Japan and the United Kingdom, for people with nAMD and DME, and submissions to other authorities regulations are underway.5,10,11,12 Globally, more than 100,000 doses of faricimab have been distributed to date for the treatment of these conditions.13 Roche also continues to explore areas where faricimab has the potential to provide additional benefits to patients, including retinal vein occlusion.
TENAYA and LUCERNE trials
The results of the TENAYA and LUCERNE phase III trials showed that faricimab (Hoffman-La Roche) INTERESTED-2 DIFFERENT MANUFACTURERS? met the primary efficacy endpoints of non-inferiority to aflibercept (Eylea, Regeneron Pharmaceuticals) in change in best corrected visual acuity (BCVA), durability and safety for the treatment of patients with neovascular AMD, according to Robyn Guymer, ADD DEGREE? professor of ophthalmology at the University of Melbourne and deputy director of the Center for Eye Research Australia in Melbourne.
These 2 clinical trials are large, identical, randomized, double-blind investigations evaluating the dual inhibition of angiopoietin-2 and VEGF-A by faricimab.
Patients in these 112-week studies were treatment-naïve and randomized 1:1 to receive faricimab 6.0 mg up to every 16 weeks after 4 initial doses every 4 weeks or aflibercept 2.0 mg every every 8 weeks after 3 initial doses every 4 weeks. .
After initial dosing and disease activity assessments, patients receiving faricimab were treated at fixed intervals, i.e. every 16 weeks, every 12 weeks or every 8 weeks.
Patients treated with faricimab then underwent a personalized treatment interval, that is, a protocol-based treatment and extension regimen with interval adjustment that was based on individualized treatment responses such as as assessed by predefined anatomical and functional criteria at study drug dosing visits. at week 108.
The primary efficacy endpoint was the change in BCVA from baseline averaged over weeks 40, 44 and 48 and compared to aflibercept.
The secondary safety criteria were the proportions of patients treated every 8, every 12 and every 16 weeks; the proportion of patients who had increases of 15 letters or more or who did not have losses of 15 letters or more; and changes in BCVA and central subfield (CST) thickness over time.
Safety endpoints were incidence and severity and non-ocular adverse events.
YOSEMITE and RHINE trials
The 1-year results from the ongoing 2-year YOSEMITE and RHINE trials have shown favorable results for faricimab in the treatment of DME. The visual gains obtained with administration every 16 weeks were non-inferior to those of aflibercept (Eylea) administered every 8 weeks.
Anatomical gains also favored faricimab over aflibercept. Faricimab has also demonstrated a good safety profile with very low levels of inflammation. John Wells, MD, of the Palmetto Retina Center, West Columbia, SC, presented the findings at the Association for Research in Vision and Ophthalmology’s virtual 2021 annual meeting on behalf of investigators YOSEMITE and RHINE.
The YOSEMITE and RHINE trials, which are identical, randomized, double-blind studies, compared the efficacy, durability, and safety of faricimab versus aflibercept in patients with center-involved DME who were either treatment-naive treatment, or having received previous treatment with an anti-VEGF treatment.
Patients were randomized 1:1:1 to receive faricimab 6.0 mg every 8 weeks after 6 initial doses every 4 weeks; faricimab 6.0 mg treated according to a personalized treatment interval (PTI) based on the concept of treatment and extension after 4 initial doses every 4 weeks; or aflibercept 2.0 mg every 8 weeks after 5 initial doses every 4 weeks.
The primary efficacy endpoint was the mean change in BCVA from baseline over weeks 48, 52 and 56 of the study. ) Severity Scale ) from baseline, the proportion of patients with a gain of 15 or more in ETDRS letters from baseline, the change in CST from baseline, and the proportion of patients in the ITP arm receiving doses every 4, every 8, every 12, or every 16 weeks to 1 year.
1. Bright Focus foundation. Age-related macular degeneration: facts and figures. [Internet; cited September 2022]. Available at: https://www.brightfocus.org/macular/article/age-related-macular-facts-figures.
2. Connolly E, et al. Prevalence of genetic risk factors associated with age-related macular degeneration and 4-year progression data in the Irish population. Br J Ophthalmol. 2018;102:1691–5.
3. Yau JWY, et al. Worldwide prevalence and major risk factors for diabetic retinopathy. Diabetic treatments. 2012;35:556-64.
4. Heier JS, et al. The Angiopoietin/Tie pathway in retinal vascular disease: a review. Retina-J Ret Vit Dis. 2021;41:1-19.
5. European Medicines Agency. Summary of product characteristics, Vabysmo, 2022.
6. Wells JA, et al. Faricimab in diabetic macular edema: two-year results of phase III YOSEMITE and RHINE trials. Presented at: Angiogenesis, Exudation and Degeneration 2022.
7. Heier JS, et al. Efficacy, durability and safety of intravitreal faricimab up to every 16 weeks in neovascular age-related macular degeneration (TENAYA and LUCERNE): two randomized, double-blind, phase III, non-inferiority trials. The Lancet. 2022;399(10326):741-755, https://doi.org/10.1016/S0140-6736(22)00010-1.
8. Wykoff C, et al. Efficacy, durability and safety of intravitreal faricimab with prolonged dosing up to every 16 weeks in patients with DME (YOSEMITE and RHINE): two randomized, double-blind, phase 3 trials. The Lancet. 2022;399(10326):729-740, https://doi.org/10.1016/S0140-6736(22)00018-6.
9. Khanani A, et al. Faricimab in neovascular age-related macular degeneration: efficacy, safety and durability results from the second year of the TENAYA and LUCERNE phase III trials. Presented at the 2022 American Society of Retina Specialists Annual Scientific Meeting; 2022.
10. US Food and Drug Administration (FDA). Prescription Information Highlights, Vabysmo. 2022. [Internet; cited September 2022]. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761235s000lbl.pdf
11. The UK Medicines and Health Products Regulatory Agency approves faricimab under an international work-sharing initiative. [Internet; cited September 2022]. Available at: https://www.gov.uk/government/news/mhra-approves-faricimab-through-international-work-sharing-initiative.
12. Chugai obtains regulatory approval for Vabysmo, the first bispecific antibody in ophthalmology, for neovascular age-related macular degeneration and diabetic macular edema. [Internet; cited September 2022]. Available at: https://www.chugai-pharm.co.jp/news/cont_file_dl.php?f=220328eVabysmo_DME_nAMD_approval.pdf&src=[%0],[%1]&rep=130 909
13. Archived Roche Data
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