biostudies-literatureUnknown142(10)Bressler SB<h4>Importance</h4>Biosimilars may be lower-cost alternatives to originator biologic products, potentially offering expanded access or reduced economic burden, but have not been evaluated with aflibercept in diabetic macular edema (DME).<h4>Objective</h4>To compare efficacy and safety of MYL-1701P, an aflibercept biosimilar, with reference aflibercept (Eylea [Regeneron]) in DME.<h4>Design, setting, and participants</h4>This was a double-masked, randomized clinical trial that included participants at 77 centers across the US, Europe, Japan, and India. Included in the analysis were individuals 18 years and older with type 1 or type 2 diabetes with central DME and best-corrected visual acuity (BCVA) letter score of 73 to 38 in the study eye using an Early Treatment Diabetic Retinopathy Study JAMA ophthalmology952-960https://www.ebi.ac.uk/biostudies/studies/S-EPMC11393752biostudies-literatureAflibercept Biosimilar MYL-1701P vs Reference Aflibercept in Diabetic Macular Edema: The INSIGHT Randomized Clinical Trial.PMC11393752Kawasaki TAgrawal VMatsuda SGordon AJDessouki ALOshima YKrzyzanek DZolotarev AAstakhov YWatanabe MAstakhov SKannan NBThach ABYoshizumi YMansour SEKamei MAngle BNBerger ASFox GMVarsanyi BRehak JSaito IFuruta MBorcz ELaganovska GErnest JDoi NSaravanan VRNatesh SApte RSAggarwal SBressler SBKiss KKFeltgen NImaizumi HStoller GLStudnicka JDavies JBPanchal BKishino GFine HFGhorayeb GRKellner UHanemoto TTabassian AROzolina SEremina AVohra RBudzinskaya MElhence AGupta VChang MAIshii KJohnson TMFujita HOjima ABrown DMFluder EMEbihara NDahlke CPd KLGamulescu MAOtake HSamoylov AYadav NKDegi RWylegala EBeckmann KMarcus DMDugel PUAgarwal SKaga TIzmaylov AShkvorchenko DKobayashi NKalvodova BTsorbatzoglou AAgarwal KKaza HNoge SBaumane KPatel SSKerenyi AStodulka PGrisanti SK MCAbe KBehera UCSekundo WKorda VVajas AVeith MRahul SLebedev OOh HSonawane ANawrocki JMurata KGombos KSjaarda RNReichstein DAMuramatsu TEichenbaum DAAlfaro DVINSIGHT Study GroupRaj LMazumdar SGanapathi PCBarve ARadnoti JKitaoka TChaudhry NANarayanan ROleksy PNemcansky JTanabe TSawada OZalewski DChauhan RRBarakat MRZeitz OSeres ALoganathan SBaker CWfalseAflibercept Biosimilar MYL-1701P vs Reference Aflibercept in Diabetic Macular Edema: The INSIGHT Randomized Clinical Trial.<h4>Importance</h4>Biosimilars may be lower-cost alternatives to originator biologic products, potentially offering expanded access or reduced economic burden, but have not been evaluated with aflibercept in diabetic macular edema (DME).<h4>Objective</h4>To compare efficacy and safety of MYL-1701P, an aflibercept biosimilar, with reference aflibercept (Eylea [Regeneron]) in DME.<h4>Design, setting, and participants</h4>This was a double-masked, randomized clinical trial that included participants at 77 centers across the US, Europe, Japan, and India. Included in the analysis were individuals 18 years and older with type 1 or type 2 diabetes with central DME and best-corrected visual acuity (BCVA) letter score of 73 to 38 in the study eye using an Early Treatment Diabetic Retinopathy Study 2024-01-01T00:00:00Z2024 Oct2026-06-01T22:16:34.94Z2025-04-04T00:34:35.201ZS-EPMC113937523926459910.1001/jamaophthalmol.2024.3458