Importance: Neovascular age-related macular degeneration is the leading cause of blindness in individuals 50 years or older. The availability of a ranibizumab biosimilar product (SB11) may facilitate access to an effective alternative to this treatment.
Objective: To demonstrate equivalence of efficacy, similar safety, and similar immunogenicity of SB11 compared with the reference ranibizumab.
Design, Setting, And Participants: This randomized, double-masked, parallel-group phase 3 equivalence study was conducted in 75 centers in 9 countries from March 14, 2018, to December 9, 2019, among 705 participants 50 years or older with neovascular age-related macular degeneration with active subfoveal choroidal neovascularization lesions. Analysis was performed on an intent-to-treat basis.
Interventions: Intravitreous injection of SB11 or ranibizumab, 0.5 mg, every 4 weeks through week 48.
Main Outcomes And Measures: Preplanned interim analysis after all participants completed the week 24 assessment of primary efficacy end points at week 8 for change from baseline in best-corrected visual acuity (BCVA) and week 4 for central subfield thickness (CST), with predefined equivalence margins for adjusted treatment differences of -3 letters to 3 letters for BCVA and -36 μm to 36 μm for CST.
Results: Baseline and disease characteristics among 705 randomized participants (403 women [57.2%]; mean [SD] age, 74.1 [8.5] years) were comparable between treatment groups (SB11, 351; ranibizumab, 354). Least-squares mean (SE) changes in BCVA from baseline at week 8 were 6.2 (0.5) letters in the SB11 group vs 7.0 (0.5) letters in the ranibizumab group, with an adjusted treatment difference of -0.8 letter (90% CI, -1.8 to 0.2 letters). Least-squares mean (SE) changes in CST from baseline at week 4 were -108 (5) μm in the SB11 group vs -100 (5) μm in the ranibizumab group, with an adjusted treatment difference of -8 μm (95% CI, -19 to 3 μm). Incidences of treatment-emergent adverse events (231 of 350 [66.0%] vs 237 of 354 [66.9%]), including serious treatment-emergent adverse events (44 of 350 [12.6%] vs 44 of 354 [12.4%]) and treatment-emergent adverse events leading to study drug discontinuation (8 of 350 [2.3%] vs 5 of 354 [1.4%]), were similar in the SB11 and ranibizumab groups. Immunogenicity was low, with a cumulative incidence of antidrug antibodies up to week 24 of 3.0% (10 of 330) in the SB11 group and 3.1% (10 of 327) in the ranibizumab group.
Conclusions And Relevance: These findings of equivalent efficacy and similar safety and immunogenicity profiles compared with ranibizumab support the use of SB11 for patients with neovascular age-related macular degeneration.
Trial Registration: ClinicalTrials.gov Identifier: NCT03150589.
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http://dx.doi.org/10.1001/jamaophthalmol.2020.5053 | DOI Listing |
Graefes Arch Clin Exp Ophthalmol
December 2024
Doheny Eye Institute, University of California, Los Angeles, 150 N. Orange Grove Blvd, Suite 232, Pasadena, CA, USA.
Anti-vascular endothelial growth factor (VEGF) therapies have transformed the treatment of retinal diseases. However, VEGF signaling is only one component of the complex, multifactorial pathophysiology of retinal diseases, and many patients have residual disease activity despite ongoing anti-VEGF treatment. The angiopoietin/tyrosine kinase with immunoglobulin and epidermal growth factor receptor-2 (Ang/Tie2) signaling pathway is critical to endothelial cell homeostasis, survival, integrity, and vascular stability.
View Article and Find Full Text PDFBMC Geriatr
December 2024
School of Medicine, Department of Ophthalmology, Recep Tayyip Erdogan University, Sehitler Street, No:8, Rize, 53020, Turkey.
Background: Age-related macular degeneration (AMD) stands as the primary cause of visual impairment and blindness among the elderly population. Patients over 90 years comprise a unique demographic that may necessitate particular attention. The aim of this study was to examine the clinical characteristics and treatment outcomes in patients aged 90 years or older diagnosed with neovascular age-related macular degeneration (nAMD).
View Article and Find Full Text PDFClin Ophthalmol
December 2024
Department of Ophthalmology & Vision Science, University of California Davis Eye Center, Sacramento, CA, USA.
Purpose: To report our real-world experience using intravitreal faricimab, a novel anti-vascular endothelial growth factor (anti-VEGF) therapy, in eyes with neovascular age-related macular degeneration (nAMD) previously treated with other anti-VEGF therapy.
Patients And Methods: A retrospective, single-center study of previously treated nAMD eyes treated with faricimab.
Results: In 88 eyes (73 patients), mean baseline best-corrected visual acuity (BCVA) was 20/63 (range 20/20 to CF) with mean anti-VEGF injection interval of 6.
Br J Ophthalmol
December 2024
State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-Sen University, Guangdong Provincial Key Laboratory of Ophthalmology and Visual Science, Guangdong Provincial Clinical Research Center for Ocular Diseases, Guangzhou 510060, Guangdong, China
Purpose: To explore the relationship between characteristics of macular neovascularisation (MNV) and photoreceptor integrity in patients with neovascular age-related macular degeneration (nAMD).
Methods: This prospective study enrolled treatment-naïve nAMD eyes and conducted a 3-month follow-up. 16 quantitative MNV features were evaluated using optical coherence tomography angiography, and the impaired areas of ellipsoid zone (EZ), external limiting membrane (ELM) and outer nuclear layer (ONL) were obtained using optical coherence tomography.
Ophthalmol Retina
December 2024
Center for Ophthalmic Bioinformatics, Cole Eye Institute, Cleveland Clinic, Cleveland, OH, USA; Cleveland Clinic Martin Hospitals, Cleveland Clinic Florida, Stuart, FL. Electronic address:
Objective: To evaluate the impact of total duration of intraretinal fluid (IRF) exposure on visual acuity and vision-related quality of life in patients with neovascular age-related macular degeneration (nAMD).
Design: A post hoc analysis of integrated data from the VIEW 1 and VIEW 2 trials.
Participants: Patients with nAMD.
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