Products > Ophthalmology > VABYSMO® (Faricimab) > DME Efficacy
Efficacy
Vision Gains
Vabysmo deliver robust vision gains with few injections§,4
*VABYSMO dosed up to Q16W met the primary endpoint, demonstrating noninferior vision gains vs aflibercept 2.0 mg Q8W, averaged over Week 48, 52 and 56 in both YOSEMITE and RHINE.2 †Aflibercept 2.0 mg Q8W initial dosing was 5 x monthly. VABYSMO 6.0 mg Q8W initial dosing was 6 x monthly. ‡Adjusted mean BCVA change from baseline, averaged over Week 92, 96 and 100. §Median of 3 injections between Week 60 and 96 for patients in VABYSMO 6.0 mg up to Q16W arm and a median of 5 injections between Week 60 and 96 for patients in VABYSMO 6.0 mg Q8W and aflibercept 2.0 mg Q8W arms.
Achieve greater CST reductions, maintained with few injections‖4
*Nominal P<0.05 vs aflibercept 2.0 mg Q8W for change from baseline averaged over Week 48, 52 and 56. †Aflibercept 2.0 mg Q8W initial dosing was 5 x monthly. VABYSMO 6.0 mg Q8W initial dosing was 6 x monthly. ‡Nominal P-value vs aflibercept 2.0 mg Q8W for change from baseline at Week 16. §Nominal P<0.05 vs aflibercept 2.0 mg Q8W for change from baseline over Week 92, 96 and 100. ‖Median of 3 injections between Week 60 and 96 for patients in the VABYSMO 6.0 mg up to Q16W arm and a median of 5 injections between Week 60 and 96 for patients in the VABYSMO 6.0 mg Q8W arm and aflibercept 2.0 mg Q8W arm.
Anatomical Improvements
Rapidly resolve IRF in more patients20
*Nominal P<0.05 vs aflibercept 2.0 mg Q8W.
Achieve resolution of DME in more patients over 2 years†20
*Nominal p<0.05 vs aflibercept 2.0 mg Q8W. †Resolution of DME and absence of DME are defined as CST ≤ 325 microns and not absolute absence of fluid.
Drying
Vabysmo deliveres fast drying with few injections
Rapidly resolve IRF in more patients20
*Summaries of time to first absence of IRF are Kaplan-Meier estimates. †Median number of injections required to achieve 50% cumulative incidence of first absence of IRF. ‡HR:1.67. Stratified analyses for HR and log-rank test. Stratification factors are baseline BCVA, prior intravitreal anti-VEGF therapy, 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. Statistics for pairwise comparisons were calculated using a separate model for each comparison. HRs were estimated by Cox regression.
*Absence of DME was defined as CST < 325 μm. †Median number of injections required to achieve 75% cumulative incidence of first absence of DME. ‡HR:1.37 for VABYSMO 6.0mg Q8W, HR:1.47 for VABYSMO 6.0 mg up to Q16W. Stratified analyses for HR and log-rank test. Stratification factors are baseline BCVA, prior intravitreal anti-VEGF therapy, 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. Statistics for pairwise comparisons were calculated using a separate model for each comparison. HRs were estimated by Cox regression.
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 96 in the VABYSMO 6.0 mg up to Q16W arm. †During Week 60-96. Patients in the aflibercept arm were fixed at Q8W interval.
DME
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