Efficacy and Safety of Abicipar in Neovascular Age-Related Macular Degeneration

Kunimoto, Derek; Yoon, Young Hee; Wykoff, Charles C.; Chang, Andrew; Khurana, Rahul N.; Maturi, Raj K.; Agostini, Hansjürgen; Souied, Eric H.; Chow, David R.; Lotery, Andrew; Ohji, Masahito; Bandello, Francesco; Belfort, Rubens; Li, Xiaoyan; Jiao, Jenny; Le, Grace; Schmidt, W.; Hashad, Yehia; Cedar,; Groups, Sequoia Study

doi:10.1016/j.ophtha.2020.03.035

Cited by 77 publications

(61 citation statements)

References 33 publications

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“…Study completion rates were 70.8% (446/630), 70.7% (444/628), and 82.7% (521/630) in the abicipar Q8, abicipar Q12, and ranibizumab Q4 groups, respectively. Ocular AEs, mostly associated with IOI, led to the discontinuation of 8.9% of abicipar-treated patients during the first year of the study 14 and accounted for the difference among groups in study completion rates. During the second year of the study, the rate of study discontinuations for any reason was 10%-12% across all treatment groups (Fig.…”

Section: Resultsmentioning

confidence: 99%

“…The analyses used an adjusted alpha level of 0.049, corresponding to a 2-sided 95.1% CI, to take into account an alpha of 0.001 allocated for selected unmasked reviews during the study by the Data and Safety Monitoring Committee. 14…”

Section: Discussionmentioning

confidence: 99%

“…The CEDAR (NCT02462928) and SEQUOIA (NCT02462928) trials were randomized, double-masked, parallel-group clinical trials with identical protocols; the data from both trials were pooled for analysis. The study design and methods were published previously 14 and are summarized here. An Institutional Review Board (IRB)/Ethics Committee approved the study at each site.…”

Section: Methodsmentioning

confidence: 99%

“…14 Intraocular inflammation (IOI) during the first study year was more frequent with abicipar than ranibizumab (the incidence of IOI adverse events [AEs] was 15.4%, 15.3%, and 0.3%, in the abicipar Q8, abicipar Q12, and ranibizumab Q4 groups, respectively) and typically occurred after one of the initial anti-VEGF injections. 14 The long-term safety and efficacy of anti-VEGF regimens in nAMD is important, because nAMD is a chronic disease usually requiring life-long therapy. 15 Here we report the pooled study, 2-year safety and efficacy results of the completed CEDAR and SEQUOIA trials.…”

Section: J O U R N a L P R E -P R O O Fmentioning

confidence: 99%

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Two-Year Results of the Phase 3 Randomized Controlled Study of Abicipar in Neovascular Age-Related Macular Degeneration

et al. 2021

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This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.

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Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: J O U R N a L P R E -P R O O Fmentioning

confidence: 99%

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Two-Year Results of the Phase 3 Randomized Controlled Study of Abicipar in Neovascular Age-Related Macular Degeneration

et al. 2021

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“…Based on the data of the REACH trial, two phase III studies in wet AMD were performed (CEDAR [NCT02462928] and SEQUOIA [NCT02462486]), and both have met their primary efficacy endpoints, with the 2-year results showing that > 90% of patients dosed at 12-week intervals experienced visual benefits similar to those receiving ranibizumab q4w, thus reducing the treatment burden by 60% [33]. In summary, the phase III data indicate that abicipar has the potential to be the first drug allowing convenient and fixed once-per-quarter dosing without reassessing patients in between.…”

Section: Abiciparmentioning

confidence: 99%

Beyond Antibodies: The DARPin® Drug Platform

Stumpp

Dawson

2020

BioDrugs

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The DARPin ® drug platform was established with a vision to expand the medical use of biologics beyond what was possible with monoclonal antibodies. It is based on naturally occurring ankyrin repeat domains that are typically building blocks of multifunctional human proteins. The platform allows for the generation of diverse, well-behaved, multifunctional drug candidates. Recent clinical data illustrate the favorable safety profile of the first DARPin ® molecules tested in patients. With the positive phase III results of the most advanced DARPin ® drug candidate, abicipar, the DARPin ® drug platform is potentially about to achieve its first marketing approval. This review highlights some of the key milestones and decisions encountered when transforming the DARPin ® platform from an academic concept to a biotech drug pipeline engine.

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Antibody mimetics: The next generation antibody engineering, a retrospective and prospective analysis

Zhang,

Wu,

Dang

2023

Biotechnology Journal

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Antibody mimetics represent the fourth generation of antibody engineering, following polyclonal antibodies, monoclonal antibodies, and genetically engineered antibody fragments. Despite cumulative studies highlighting the advantages of antibody mimetics, including enhanced recognition properties, superior affinity, stability, penetrability, and cost‐effectiveness, a comprehensive review of this evolving field is notably absent. In this study, spanning 1986–2023 and analyzing 24,318 publications, we undertake a retrospective and prospective analysis to elucidate the evolution roadmap of antibody mimetics, providing insights into the current landscape, global contributions, and future trajectories. Concurrently, our aim is to establish standardized terminology and delineate the research scope within the realm of antibody mimetics. These endeavors not only chart the trajectory and scope of antibody mimetics research but also underscore its potential to revolutionize medicine, technology, and science.

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Efficacy and Safety of Abicipar in Neovascular Age-Related Macular Degeneration

Cited by 77 publications

References 33 publications

Two-Year Results of the Phase 3 Randomized Controlled Study of Abicipar in Neovascular Age-Related Macular Degeneration

Two-Year Results of the Phase 3 Randomized Controlled Study of Abicipar in Neovascular Age-Related Macular Degeneration

Beyond Antibodies: The DARPin® Drug Platform

Antibody mimetics: The next generation antibody engineering, a retrospective and prospective analysis

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