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| http://dx.doi.org/10.1038/s41433-023-02813-4 | DOI Listing |
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Transitioning from Aflibercept to Biosimilar Ranibizumab in Diabetic Macular Edema (DME): (The TRANSFORM-DME Trial) a Multicenter Observational Study.
Clin Ophthalmol
November 2024
Department of Vitreoretinal Services, Disha Eye Hospitals, Kolkata, West Bengal, India.
Article Synopsis
- The study aimed to assess the visual and anatomical outcomes in diabetic macular edema (DME) patients who switched from intravitreal Aflibercept (IVI AFL) to biosimilar Ranibizumab (B-RBZ) due to financial reasons rather than efficacy issues.
- A total of 57 DME patients were observed, showing substantial improvement in visual acuity during treatment with Aflibercept and a slight decline after switching to Ranibizumab, but overall vision remained better than the initial baseline.
- The transition maintained anatomical stability in terms of central macular thickness and reduced subretinal and intra retinal fluid levels, indicating that biosimilar Ranibizumab is an effective and cost-efficient therapeutic option
Expert Panel Consensus for Optimizing Outcomes in Neovascular Age-Related Macular Degeneration in the Context of Suboptimal Response to a Biosimilar: The Role of Aflibercept.
Clin Ophthalmol
November 2024
Bayer plc, Reading, UK.
Purpose: The inclusion of ranibizumab biosimilars into National Health Service England commissioning recommendations published in 2022 created a need for expert guidance to optimize treatment outcomes in patients with neovascular age-related macular degeneration (nAMD) who otherwise may not have received first-line ranibizumab. This article provides a consensus treatment pathway supporting timely identification and management of a suboptimal response to these therapies, thereby aiming to facilitate clinically meaningful outcomes and efficient management of service capacity under specific circumstances where ranibizumab biosimilars may be initiated as a first-line treatment.
Methods: Two structured round-table meetings of UK medical retina specialists were held in person and virtually on September 22 and November 3, 2022, respectively.
Nonclinical Similarity of the Biosimilar Candidate ABP 938 with Aflibercept Reference Product.
Ophthalmol Ther
November 2024
Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA, 91320-1799, USA.
Introduction: ABP 938 is being developed as a biosimilar to Eylea (aflibercept reference product [RP]), an anti-vascular endothelial growth factor (VEGF) drug used in the management of retinal diseases. Previously, a comparative analytical similarity assessment demonstrated that ABP 938 and aflibercept RP have the same amino acid sequence and exhibit similar higher-order structure and biological activity. The nonclinical studies described here were designed to assess the in vitro pharmacology and the in vivo pharmacokinetics (PK), toxicokinetics (TK), and safety profiles of ABP 938 compared to aflibercept RP.
View Article and Find Full Text PDFStakeholder insights on cost, quality, and incorporating patient voice in managed care decisions on neovascular (wet) age-related macular degeneration: Findings from the AMCP Market Insights program.
J Manag Care Spec Pharm
November 2024
Devoted Health, Waltham, MA.
Wet age-related macular degeneration (AMD) is an acquired degeneration of the retina that can lead to central vision impairment. It is primarily treated with intravitreal injections of vascular endothelial growth factor inhibitors. Although vascular endothelial growth factor inhibitors can effectively prevent progression of vision loss in many patients, they require ongoing regular administration and are therefore associated with considerable treatment burden.
View Article and Find Full Text PDFEFFICACY AND SAFETY OF THE PROPOSED BIOSIMILAR AFLIBERCEPT, SDZ-AFL, IN PATIENTS WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION: 52-Week Results From the Phase 3 Mylight Study.
Retina
October 2024
Faculty of Medicine, University of Coimbra, Coimbra, Portugal.
Purpose: The Phase 3 Mylight study was designed to confirm clinical equivalence of proposed biosimilar aflibercept (SOK583A1; Sandoz [proposed biosimilar aflibercept, SDZ-AFL]) to its reference biologic (Eylea; Regeneron Pharmaceuticals, Inc; Bayer AG [reference aflibercept, Ref-AFL]).
Method: Mylight was a prospective, double-masked, 2-arm, parallel Phase 3 study. Participants with neovascular age-related macular degeneration were randomized 1:1 to receive eight injections of SDZ-AFL (n = 244) or Ref-AFL (n = 240) over 48 weeks.
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