{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"omics_type":["Unknown"],"volume":["142(10)"],"submitter":["Bressler SB"],"pubmed_abstract":["Importance
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).Objective
To compare efficacy and safety of MYL-1701P, an aflibercept biosimilar, with reference aflibercept (Eylea [Regeneron]) in DME.Design, setting, and participants
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 "],"journal":["JAMA ophthalmology"],"pagination":["952-960"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC11393752"],"repository":["biostudies-literature"],"pubmed_title":["Aflibercept Biosimilar MYL-1701P vs Reference Aflibercept in Diabetic Macular Edema: The INSIGHT Randomized Clinical Trial."],"pmcid":["PMC11393752"],"pubmed_authors":["Kawasaki T","Agrawal V","Matsuda S","Gordon AJ","Dessouki AL","Oshima Y","Krzyzanek D","Zolotarev A","Astakhov Y","Watanabe M","Astakhov S","Kannan NB","Thach AB","Yoshizumi Y","Mansour SE","Kamei M","Angle BN","Berger AS","Fox GM","Varsanyi B","Rehak J","Saito I","Furuta M","Borcz E","Laganovska G","Ernest J","Doi N","Saravanan VR","Natesh S","Apte RS","Aggarwal S","Bressler SB","Kiss KK","Feltgen N","Imaizumi H","Stoller GL","Studnicka J","Davies JB","Panchal B","Kishino G","Fine HF","Ghorayeb GR","Kellner U","Hanemoto T","Tabassian AR","Ozolina S","Eremina A","Vohra R","Budzinskaya M","Elhence A","Gupta V","Chang MA","Ishii K","Johnson TM","Fujita H","Ojima A","Brown DM","Fluder EM","Ebihara N","Dahlke C","Pd KL","Gamulescu MA","Otake H","Samoylov A","Yadav NK","Degi R","Wylegala E","Beckmann K","Marcus DM","Dugel PU","Agarwal S","Kaga T","Izmaylov A","Shkvorchenko D","Kobayashi N","Kalvodova B","Tsorbatzoglou A","Agarwal K","Kaza H","Noge S","Baumane K","Patel SS","Kerenyi A","Stodulka P","Grisanti S","K MC","Abe K","Behera UC","Sekundo W","Korda V","Vajas A","Veith M","Rahul S","Lebedev O","Oh H","Sonawane A","Nawrocki J","Murata K","Gombos K","Sjaarda RN","Reichstein DA","Muramatsu T","Eichenbaum DA","Alfaro DV","INSIGHT Study Group","Raj L","Mazumdar S","Ganapathi PC","Barve A","Radnoti J","Kitaoka T","Chaudhry NA","Narayanan R","Oleksy P","Nemcansky J","Tanabe T","Sawada O","Zalewski D","Chauhan RR","Barakat MR","Zeitz O","Seres A","Loganathan S","Baker CW"],"additional_accession":[]},"is_claimable":false,"name":"Aflibercept Biosimilar MYL-1701P vs Reference Aflibercept in Diabetic Macular Edema: The INSIGHT Randomized Clinical Trial.","description":"Importance
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).Objective
To compare efficacy and safety of MYL-1701P, an aflibercept biosimilar, with reference aflibercept (Eylea [Regeneron]) in DME.Design, setting, and participants
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 ","dates":{"release":"2024-01-01T00:00:00Z","publication":"2024 Oct","modification":"2026-06-01T22:16:34.94Z","creation":"2025-04-04T00:34:35.201Z"},"accession":"S-EPMC11393752","cross_references":{"pubmed":["39264599"],"doi":["10.1001/jamaophthalmol.2024.3458"]}}