Products > Ophthalmology > VABYSMO® (Faricimab) > AMD Efficacy
Efficacy
Vision Gains
Deliver vision gains with half the number of injections§3
*VABYSMO dosed up to Q16W met the primary endpoint, demonstrating noninferior vision gains vs aflibercept 2.0 mg Q8W, averaged over Week 40, 44 and 48 in both TENAYA and LUCERNE.1 †Aflibercept 2.0 mg Q8W initial dosing was 3 x monthly. ‡Adjusted mean BCVA change from baseline, averaged over Week 104, 108 and 112. §Median of 3 injections between Week 60 and 112 for patients in the VABYSMO 6.0 mg up to Q16W arm and a median of 6 injections between Week 60 and 112 for patients in the aflibercept 2.0 mg Q8W arm.
Anatomical Improvements
Achieve early CST reductions, maintained with half the number of injections||3
* Adjusted mean CST change from baseline at 1 year, averaged over Week 40, 44 and 48. CST is measured as ILM RPE. †Aflibercept 2.0 mg Q8W initial dosing was 3 x monthly. ‡Nominal P-value vs aflibercept 2.0 mg Q8W for change from baseline at Week 12.16 §Adjusted mean CST change from baseline, averaged over Week 104, 108 and 112. CST is measured as ILM-RPE. IIMedian of 3 injections between Week 60 and 112 for patients in the VABYSMO 6.0 mg up to Q16W arm and a median of 6 injections between Week 60 and 112 for patients in the aflibercept 2.0 mg Q8W arm.
Anatomical Improvements
Rapidly resolve fluid in more patients†14
*Nominal p<0.05 vs aflibercept 2.0 mg Q8W. †Resolution of fluid is defined as absence of SRF and IRF. IRF is as measured in the central subfield (centre 1 mm).
Drying
Vabysmo delivers fast drying with few injections
*Absence of retinal fluid defined as absence of IRF and SRF. IRF and SRF are as measured in the central subfield (centre 1 mm). Event is defined as the first absence of IRF and SRF after randomisation date. Patients with absence of IRF and SRF at baseline were excluded from the analysis. †Median number of injections required to achieve 75% cumulative incidence of absence of IRF and SRF. ‡HR:1.46. Stratified analyses for HR and log-rank test. Stratification factors are baseline BCVA, baseline LLD, region and study. HRs were estimated by Cox regression. P values are nominal and not adjusted for multiplicity; no formal statistical conclusion should be made based on the P values.
Durability
VABYSMO deliverers extended durability with 80% of patients on >=Q12W and 60% of patients on Q16W treatment intervals at Year2
*Patients with evaluable data at Week 60-112 in the VABYSMO 6.0 mg up to Q16W arm. †During treat-and-extend phase. Patients in the aflibercept arm were fixed at Q8W interval.
AMD
Efficacy
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