Products > Ophthalmology > VABYSMO® (Faricimab) > DME Safety
Safety
Comparable safety profile to aflibercept demonstrated over 2 years20,21
Results are presented for the pooled YOSEMITE/RHINE safety-evaluable population. Multiple occurrences of the same AE in one individual are counted only once except for the "Total number of AEs" and "Total number of SAEs" rows in which multiple occurrences of the same AE are counted separately. *Total number of AEs and SAEs includes ocular events in both study and fellow eye, as well as non-ocular events. †Ocular AEs in study eye only are presented in all safety outputs. ‡Excluding endophthalmitis. §Anti-Platelet Trialists' Collaboration (APTC) events were adjudicated by an external independent committee.
> 2,000,000 vials of VABYSMO have been distributed in the US as of October 202325
DME
Safety
Contact
Roche Pharmaceuticals (Israel) Ltd.
6 Hacharash St. Hod Hasharon
Telephone: 09-9737777
E-mail: israel.ophthalmology@roche.com
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List of abbreviations
- AEs: adverse events
- AMD: age-related macular degeneration
- Ang-2: angiopoietin-2
- APTC: Anti-Platelet Trialists’ Collaboration
- BCVA: best corrected visual acuity
- CNV: choroidal neovascularisation
- CST: central subfield thickness
- DME: diabetic macular oedema
- DR: diabetic retinopathy
- DRSS: diabetic retinopathy severity scale
- ETDRS: early treatment diabetic retinopathy study
- ETDRS-DRSS: early treatment diabetic retinopathy study diabetic retinopathy severity scale
- Fc: fragment crystallisable
- FFA: fundus fluorescein angiography
- HbA1c: glycated haemoglobin
- IOI: intraocular inflammation
- ILM: inner limiting membrane
- ILM-RPE: inner limiting membrane-retinal pigment epithelium
- IRF: intraretinal fluid
- IVT: intravitreal
- nAMD: neovascular age-related macular degeneration
- NPDR: non-proliferative diabetic retinopathy
- PDR: proliferative diabetic retinopathy
- RAP: retinal angiomatous proliferation
- RPE: retinal pigment epithelium
- SAE: serious adverse events
- SD: standard deviation
- SRF: subretinal fluid
- VEGF: vascular endothelial growth factor
- VEGF-A: vascular endothelial growth factor-A
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References
1. Heier JS, et al. Lancet. 2022;399(10326):729-40.
2. Wykoff CC, et al. Lancet. 2022;399(10326):741-755.
3. Holz FG, et al. Presented at EURETINA 2022, Hamburg, Germany, 1–4 September 2022.
4. Schlottmann PG, et al. Presented at EURETINA 2022, Hamburg, Germany, 1–4 September 2022.
5. Ciulla TA, et al. Ophthalmol Retina. 2020;4(1):19–30.
6. Skelly A, et al. Vision (Basel). 2019;3:41.
7. DeCroos FC, et al. Am J Ophthalmol. 2017;180:142–50.
8. Ciulla TA, et al. Br J Ophthalmol. 2021;105(2):216–221.
9. Heier JS, et al. Retina. 2021;41(1):1–19.
10. Regula JT, et al. EMBO Mol Med. 2016;8:1265–88.
11. Saharinen P, et al. Nat Rev Drug Discov. 2017;16:635–661.
12. Joussen AM, et al. Eye. 2021;35:1305–1316.
13. Khanani AM, et al. Ophthalmol Sci. 2021;1(4):100076.
14. Priglinger SG, et al. Presented at the Macula Society 45th Annual Meeting, Berlin, Germany, June 8–11, 2022.
15. Data on File. nAMD. Change from Baseline in CST. October 2020.
16. Data on File. nAMD. Summary of Clinical Safety. June 2022.
17. Eter N, et al. Ophthalmol Sci. 2022;2(1):100111.
18. Heier JS, et al. Presented at the Annual Meeting of the American Academy of Ophthalmology Retina Subspecialty Day 2021, New Orleans, LA, November 12–13, 2021.
19. Data on File. DME. Change from Baseline in CST. November 2021.
20. Baumal CR, et al. Presented at the Association for Research in Vision and Ophthalmology, Denver, CO, May 1–4, 2022.
21. Data on File. DME. Summary of Clinical Safety. February 2022.
22. Figueroa MS, et al. Presented at the 22nd EURETINA Congress, Hamburg, Germany, September 1–4, 2022.
23. Data on File. nAMD. Patient Case. September 2022.
24. Data on File. DME. Patient Case. September 2022.
25. Roche Data on File
Do you have general questions? Feel free to contact us.
Roche Pharmaceuticals (Israel) Ltd.
6 Hacharash St. Hod Hasharon
Telephone: 09-9737777
E-mail: israel.ophthalmology@roche.com