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Faricimab Treat-and-Extend for Diabetic Macular Edema: 2-Year Results from the Randomized Phase 3 YOSEMITE and RHINE Trials

dc.rights.licenseopenen_US
dc.contributor.authorWONG, Tien Y
dc.contributor.authorHASKOVA, Zdenka
dc.contributor.authorASIK, Kemal
dc.contributor.authorBAUMAL, Caroline R
dc.contributor.authorCSAKY, Karl G
dc.contributor.authorETER, Nicole
dc.contributor.authorIVES, Jane A
dc.contributor.authorJAFFE, Glenn J
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorKOROBELNIK, Jean-Francois
dc.contributor.authorLIN, Hugh
dc.contributor.authorMURATA, Toshinori
dc.contributor.authorRUAMVIBOONSUK, Paisan
dc.contributor.authorSCHLOTTMANN, Patricio G
dc.contributor.authorSERES, Andras I
dc.contributor.authorSILVERMAN, David
dc.contributor.authorSUN, Xiaodong
dc.contributor.authorTANG, Yannan
dc.contributor.authorWELLS, John A
dc.contributor.authorYOON, Young Hee
dc.contributor.authorWYKOFF, Charles C
dc.date.accessioned2024-02-20T12:53:41Z
dc.date.available2024-02-20T12:53:41Z
dc.date.issued2023-12-27
dc.identifier.issn1549-4713en_US
dc.identifier.urihttps://oskar-bordeaux.fr/handle/20.500.12278/188258
dc.description.abstractEnPURPOSE: To evaluate the 2-year efficacy, durability, and safety of dual angiopoietin-2/vascular endothelial growth factor (VEGF)-A pathway inhibition with intravitreal faricimab according to a personalized treat-and-extend-based regimen (T&E) with up to every-16-week (Q16W) dosing in the YOSEMITE/RHINE (NCT03622580/NCT03622593) phase 3 trials of diabetic macular edema (DME). DESIGN: Randomized, double-masked, noninferiority phase 3 trials. PARTICIPANTS: Adults with visual acuity loss due to center-involving DME. METHODS: Patients were randomized 1:1:1 to faricimab 6.0 mg Q8W, faricimab 6.0 mg T&E (previously referred to as personalized treatment interval), or aflibercept 2.0 mg Q8W. The T&E up to Q16W dosing regimen was based on central subfield thickness (CST) and best-corrected visual acuity (BCVA) change. MAIN OUTCOME MEASURES: Included changes from baseline in BCVA and CST, number of injections, durability, absence of fluid, and safety through week 100. RESULTS: In YOSEMITE/RHINE (N=940/951), noninferior year 1 visual acuity gains were maintained through year 2; mean BCVA change from baseline at 2 years (weeks 92/96/100 average) with faricimab Q8W (YOSEMITE/RHINE, +10.7/+10.9 letters) or T&E (+10.7/+10.1 letters) were comparable with aflibercept Q8W (+11.4/+9.4 letters). The median number of study drug injections was lower with faricimab T&E (YOSEMITE/RHINE, 10/11 injections) versus faricimab Q8W (15 injections) and aflibercept Q8W (14 injections) across both trials during the entire study. In the faricimab T&E arms, durability was further improved during year 2, with >60% of patients on Q16W dosing and ∼80% on ≥Q12W dosing at week 96. Almost 80% of patients who achieved Q16W dosing at week 52 maintained Q16W dosing without an interval reduction through week 96. Mean CST reductions were greater, and more patients achieved absence of DME (CST <325μm) and absence of intraretinal fluid with faricimab Q8W or T&E versus aflibercept Q8W through year 2. Overall, faricimab was well tolerated, with a safety profile comparable to aflibercept. CONCLUSIONS: Clinically meaningful visual acuity gains from baseline, anatomic improvements, and extended durability with intravitreal faricimab up to Q16W were maintained through year 2. Faricimab given as a personalized T&E-based dosing regimen supports the role of dual angiopoietin-2/VEGF-A inhibition to promote vascular stability and provide durable efficacy for patients with DME.
dc.language.isoENen_US
dc.subject.enAngiopoietin-2
dc.subject.enDiabetic macular edema
dc.subject.enFaricimab
dc.subject.enVascular endothelial growth factor-A
dc.subject.enVascular stability
dc.title.enFaricimab Treat-and-Extend for Diabetic Macular Edema: 2-Year Results from the Randomized Phase 3 YOSEMITE and RHINE Trials
dc.title.alternativeOphthalmologyen_US
dc.typeArticle de revueen_US
dc.identifier.doi10.1016/j.ophtha.2023.12.026en_US
dc.subject.halSciences du Vivant [q-bio]/Santé publique et épidémiologieen_US
dc.identifier.pubmed38158159en_US
bordeaux.journalOphthalmology: Journal of The American Academy of Ophthalmologyen_US
bordeaux.hal.laboratoriesBordeaux Population Health Research Center (BPH) - UMR 1219en_US
bordeaux.institutionUniversité de Bordeauxen_US
bordeaux.institutionINSERMen_US
bordeaux.teamLEHA_BPHen_US
bordeaux.peerReviewedouien_US
bordeaux.inpressnonen_US
hal.identifierhal-04468256
hal.version1
hal.date.transferred2024-02-20T12:53:46Z
hal.popularnonen_US
hal.audienceInternationaleen_US
hal.exporttrue
dc.rights.ccPas de Licence CCen_US
bordeaux.COinSctx_ver=Z39.88-2004&amp;rft_val_fmt=info:ofi/fmt:kev:mtx:journal&amp;rft.jtitle=Ophthalmology:%20Journal%20of%20The%20American%20Academy%20of%20Ophthalmology&amp;rft.date=2023-12-27&amp;rft.eissn=1549-4713&amp;rft.issn=1549-4713&amp;rft.au=WONG,%20Tien%20Y&amp;HASKOVA,%20Zdenka&amp;ASIK,%20Kemal&amp;BAUMAL,%20Caroline%20R&amp;CSAKY,%20Karl%20G&amp;rft.genre=article


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