Genentech, a member of the Roche Group, announced data from its ophthalmology portfolio will be highlighted in 25 abstracts at the 2023 American Society of Retina Specialists (ASRS) annual meeting, which will be held from July 28 to August 1 in Seattle.
In a news release, the company indicated the data further advance the depth of clinical and real-world evidence supporting the use of faricimab (Vabysmo), the first and only bispecific antibody for the eye, for the treatment of neovascular or ‘wet’ age-related macular degeneration (nAMD) and diabetic macular oedema (DME).1-14
“The clinical and real-world data at ASRS reinforce the improvement in outcomes brought by Vabysmo in two leading causes of vision loss, particularly new analyses suggesting that Vabysmo is associated with less vision-impacting fibrosis than aflibercept,” Levi Garraway, MD, PhD, chief medical officer and Head of Global Product Development, said in the news release. “By improving disease control while offering a potentially less frequent treatment regimen, Vabysmo may help people spend less time managing their condition.”
According to the company, faricimab is currently approved in more than 70 countries to treat nAMD and DME, with public reimbursement in over 20 markets and more than one million doses distributed globally.15 Neovascular AMD and DME are two leading causes of vision loss worldwide, affecting more than 40 million people.16-19
The company indicated the following key data will be presented at ASRS in Seattle:
Late-breaker: Vabysmo’s effect on epiretinal membrane (ERM) formation in DME compared to aflibercept
Two-year post-hoc data from the YOSEMITE and RHINE phase III studies will be presented for the first time on ERM formation in DME patients, indicating faricimab leads to less retinal fibrosis than aflibercept.3 ERMs are fibrotic tissues on the surface of the retina, which may negatively impact the anatomy of the eye and compromise vision.20
Vabysmo drying and durability data
Data will be presented reiterating positive anatomical outcomes previously seen with faricimab treatment, including reduced blood vessel leakage in the macula, and greater and faster retinal fluid control.4,6,7 Blood vessel leakage can cause a build-up of fluid and swelling in the back of the eye, contributing to sight loss.21,22
Data will also further support how increased intervals between doses of faricimab to treat nAMD and DME, compared to aflibercept, do not compromise outcomes.4,6,7
Vabysmo real-world data
According to the company, its expanding program of real-world studies for faricimab includes more than 8500 participants in almost 30 countries.15
- Updates will be presented on real-world data from the FARETINA studies of faricimab in nAMD and DME looking at extended dosing intervals and impact on vision, including faricimab’s use as a first-line treatment.9,10
- Preliminary data on early outcomes and treatment patterns in the United Kingdom FARWIDE studies of faricimab in nAMD and DME will be shared for the first time.11,12
In addition, independent investigator studies of faricimab are expected to be presented. The TRUCKEE study, which focused on real-world outcomes in people with nAMD across 14 sites in the United States is scheduled for presentation on 31 July during the Wet AMD Symposium 3 (1:38 PM to 1:44 PM PDT).23
References:
1. Zarbin M, et al. An assessment of the impact of disease activity criteria on dosing interval assignment in clinical trial patients with nAMD. Paper presentation at: American Society of Retina Specialists (ASRS) Annual Meeting; 28 July – 1 August 2023.
2. Coney JM, et al. Elevatum study design and rationale: a phase IIII trial of faricimab (VABYSMO) in underrepresented patients with diabetic macular edema. Paper presentation at: ASRS Annual Meeting; 28 July – 1 August 2023.
3. Jaffe GJ, et al. Impact of faricimab vs aflibercept on epiretinal membrane formation over two years in eyes with DME in the YOSEMITE/RHINE phase III trials. Paper presentation at: ASRS Annual Meeting; 28 July – 1 August 2023.
4. Nudleman E, et al. Faricimab reduces macular leakage vs aflibercept in patients with DME. Paper presentation at: ASRS Annual Meeting; 28 July – 1 August 2023.
5. Muni RH, et al. Faricimab causes rapid and sustained intraocular suppression of Ang-2 and VEGF-A for up to 16 weeks in nAMD and DME. Paper presentation at: ASRS Annual Meeting; 28 July – 1 August 2023.
6. Rachitskaya AV, et al. Time to retinal fluid control with faricimab vs aflibercept in patients with DME in the phase III YOSEMITE/RHINE trials. Paper presentation at: ASRS Annual Meeting; 28 July – 1 August 2023.
7. London NJ, et al. Faricimab rapidly improves fluid parameters in patients with nAMD. Paper presentation at: ASRS Annual Meeting; 28 July – 1 August 2023.
8. Sun X, et al. Efficacy, durability, and safety of faricimab in DME: one-year results from China subpopulation of phase III RHINE trial. Virtual Paper on Demand Presentation at: ASRS Annual Meeting; 28 July – 1 August 2023.
9. Borkar D, et al. Early treatment patterns and outcomes in patients with diabetic macular edema treated with faricimab: the FARETINA-DME study. Paper presentation at: ASRS Annual Meeting; 28 July – 1 August 2023.
10. Leng T, et al. Early treatment patterns and outcomes in patients with neovascular age-related macular degeneration initiating faricimab: the FARETINA-AMD study. Paper presentation at: ASRS Annual Meeting; 28 July – 1 August 2023.
11. Patel PJ, et al. Real-world use of faricimab to treat nAMD patients in the UK. Virtual Paper on Demand Presentation at: ASRS Annual Meeting; 28 July – 1 August 2023.
12. Gale RP, et al. Real-world use of faricimab to treat DME patients in the UK. Poster Presentation at: ASRS Annual Meeting; 28 July – 1 August 2023.
13. United States Food and Drug Administration (U.S. FDA). Highlights of prescribing information, Vabysmo. 2022 [Internet; cited July 2023]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761235s000lbl.pdf.
14. Medicines and Healthcare products Regulatory Agency. MHRA approves faricimab through international work-sharing initiative [Internet; cited July 2023]. Available from: https://www.gov.uk/government/news/mhra-approves-faricimab-through-international-work-sharing-initiative.
15. Roche data on file.
16. Bright Focus Foundation. AMD: Facts and figures [Internet; cited July 2023]. Available from: https://www.brightfocus.org/macular/article/age-related-macular-facts-figures.
17. Connolly E, et al. Prevalence of AMD-associated genetic risk factors and four-year progression data in the Irish population. Br J Ophthalmol. 2018;102:1691–5.
18. Wong WL, et al. Global prevalence of AMD and disease burden projection for 2020 and 2040: a systematic review and meta-analysis. Lancet Glob Health. 2014;2:106–16.
19. Yau JWY, et al. Global prevalence and major risk factors of diabetic retinopathy. Diabetes Care. 2012;35:556–64.
20. Moorfields Eye Hospital NHS Foundation Trust. Epiretinal membrane [Internet; cited July 2023]. Available from: https://www.moorfields.nhs.uk/condition/epiretinal-membrane#:~:text=An%20epiretinal%20membrane%20is%20a,cause%20problems%20with%20central%20vision.
21. All About Vision. Macula lutea [Internet; cited July 2023]. Available from: https://www.allaboutvision.com/resources/macula.
22. Kaiser PK, et al. Retinal fluid and thickness as measures of disease activity in neovascular age-related macular degeneration. Retina. 2021;41:1579-86.
23. Chang EY, et al. Real-world efficacy and safety of faricimab in neovascular age-related macular degeneration: the TRUCKEE study. Paper presentation at: ASRS Annual Meeting; 28 July – 1 August 2023 Presentation.
