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Biosimilars of anti-vascular endothelial growth factor for ophthalmic diseases: A review.
Bressler, NM, Kaiser, PK, Do, DV, Nguyen, QD, Park, KH, Woo, SJ, Sagong, M, Bradvica, M, Kim, MY, Kim, S, et al
Survey of ophthalmology. 2024
Abstract
The development of intravitreally injected biologic medicines (biologics) acting against vascular endothelial growth factor (VEGF) substantially improved the clinical outcomes of patients with common VEGF-driven retinal diseases. The relatively high cost of branded agents, however, represents a financial burden for most healthcare systems and patients, likely resulting in impaired access to treatment and poorer clinical outcomes for some patients. Biosimilar medicines (biosimilars) are clinically equivalent, potentially economic alternatives to reference products. Biosimilars approved by leading health authorities have been demonstrated to be similar to the reference product in a comprehensive comparability exercise, generating the totality of evidence necessary to support analytical, pre-clinical, and clinical biosimilarity. Anti-VEGF biosimilars have been entering the field of ophthalmology in the US since 2022. We review regulatory and scientific concepts of biosimilars, the biosimilar development landscape in ophthalmology, with a specific focus on anti-VEGF biosimilars, and discuss opportunities and challenges facing the uptake of biosimilars.
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2.
Evidence and suggestions for establishing vitamin D intake standards in Koreans for the prevention of chronic diseases.
Kim, JH, Park, HS, Pae, M, Park, KH, Kwon, O
Nutrition research and practice. 2022;(Suppl 1):S57-S69
Abstract
BACKGROUND/OBJECTIVES Vitamin D is produced in the skin during sun exposure and is also ingested from foods. The role of vitamin D needs to be considered in the prevention and management of various diseases. Moreover, since the majority of Koreans spend their days indoors, becoming susceptible to the risk of vitamin D deficiency. The current study aims to prepare a basis for determining dietary reference intake of vitamin D in Korea, by reviewing the evidence against various diseases and risks. MATERIALS/METHODS Literature published in Korea and other countries between 2014 and 2018 was prioritized based on their study design and other criteria, and evaluated using the RoB 2.0 assessment form and United States Department of Agriculture Nutrition Evidence Library Conclusion Statement Evaluation Criteria. RESULTS Of the 1,709 studies, 128 studies were included in the final systematic analysis after screening. To set the dietary reference intakes of vitamin D based on the selected articles, blood 25(OH)D levels and indicators of bone health were used collectively. Blood vitamin D levels and ultraviolet (UV) exposure time derived from the Korean National Health and Nutrition Examination Survey were analyzed to establish the dietary reference intakes of vitamin D for each stage of the life cycle. The adequate intake levels of vitamin D, according to age and gender, were determined to be in the range of 5-15 μg/day, and the tolerable upper intake level was established at 25-100 μg/day. CONCLUSIONS The most important variable for vitamin D nutrition is lifestyle. A balanced diet comprising foods with high contents of vitamin D is important, as is vitamin D synthesis after UV exposure. The adequate intake level of vitamin D mentioned in the 2015 Dietary Reference Intakes for Korean (KDRI) remained unchanged in the 2020 KDRI for the management of vitamin D nutrition in Koreans.
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3.
Bioactive Sphingolipids as Major Regulators of Coronary Artery Disease.
Song, JH, Kim, GT, Park, KH, Park, WJ, Park, TS
Biomolecules & therapeutics. 2021;(4):373-383
Abstract
Atherosclerosis is the deposition of plaque in the main arteries. It is an inflammatory condition involving the accumulation of macrophages and various lipids (low-density lipoprotein [LDL] cholesterol, ceramide, S1P). Moreover, endothelial cells, macrophages, leukocytes, and smooth muscle cells are the major players in the atherogenic process. Sphingolipids are now emerging as important regulators in various pathophysiological processes, including the atherogenic process. Various sphingolipids exist, such as the ceramides, ceramide-1-phosphate, sphingosine, sphinganine, sphingosine-1-phosphate (S1P), sphingomyelin, and hundreds of glycosphingolipids. Among these, ceramides, glycosphingolipids, and S1P play important roles in the atherogenic processes. The atherosclerotic plaque consists of higher amounts of ceramide, glycosphingolipids, and sphingomyelin. The inhibition of the de novo ceramide biosynthesis reduces the development of atherosclerosis. S1P regulates atherogenesis via binding to the S1P receptor (S1PR). Among the five S1PRs (S1PR1-5), S1PR1 and S1PR3 mainly exert anti-atherosclerotic properties. This review mainly focuses on the effects of ceramide and S1P via the S1PR in the development of atherosclerosis. Moreover, it discusses the recent findings and potential therapeutic implications in atherosclerosis.
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4.
An Overview of Ophthalmologic Survey Methodology in the 2008-2015 Korean National Health and Nutrition Examination Surveys.
Yoon, KC, Choi, W, Lee, HS, Kim, SD, Kim, SH, Kim, CY, Park, KH, Park, YJ, Baek, SH, Song, SJ, et al
Korean journal of ophthalmology : KJO. 2015;(6):359-67
Abstract
The Korea National Health and Nutrition Examination Survey (KNHANES) is a national program designed to assess the health and nutritional status of the noninstitutionalized population of South Korea. The KNHANES was initiated in 1998 and has been conducted annually since 2007. Starting in the latter half of 2008, ophthalmologic examinations were included in the survey in order to investigate the prevalence and risk factors of common eye diseases such as visual impairment, refractive errors, strabismus, blepharoptosis, cataract, pterygium, diabetic retinopathy, age-related macular degeneration, glaucoma, dry eye disease, and color vision deficiency. The measurements included in the ophthalmic questionnaire and examination methods were modified in the KNHANES IV, V, and VI. In this article, we provide detailed information about the methodology of the ophthalmic examinations in KNHANES in order to aid in further investigations related to major eye diseases in South Korea.