FDA accepts application for Roche ’s Port Delivery System with ranibizumab (PDS) for treatment of neovascular or “wet” age-related macular degeneration (nAMD)

Basel, 24 June 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has accepted the company ’s Biologics License Application (BLA), under Priority Review, for Port Delivery System with ranibizumab (PDS) for the treatment of neovascular or “wet” age-related macular degeneration (nAMD). Neovascular AMD is a leading cause of blindness for people aged 60 and over and impacts approximatel y 20 million people worldwide.1,2,3 If approved, PDS would be a first-of-its-kind therapeutic approach, offering people living with nAMD an alternative to frequent eye injections of anti-vascular endothelial growth factor (VEGF), the current standard of care.4 The FDA is expected to make a decision on approval by 23 October 2021.
Source: Roche Media News - Category: Pharmaceuticals Source Type: news

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CONCLUSION: AMD contributes to the burden of visual impairment and blindness in the elderly Nigerian. In Nigeria, AMD occurs more in females and most common between the ages of 60 and 79. Dry AMD is four times more common than wet AMD. About 24% of eyes have severe visual impairment or blindness, while about a third each have a moderate visual impairment and normal vision. Increasing awareness of AMD among the at-risk population will be beneficial in achieving early diagnosis and treatment.
Source: Middle East African Journal of Ophthalmology - Category: Opthalmology Authors: Source Type: research
Clin Ther. 2021 Sep 18:S0149-2918(21)00310-6. doi: 10.1016/j.clinthera.2021.08.011. Online ahead of print.ABSTRACTPURPOSE: Age-related macular degeneration (AMD) is a leading cause of blindness, particularly in higher-income countries. Although dry AMD accounts for 85% to 90% of AMD cases, a comprehensive understanding of the global dry AMD burden is needed.METHODS: A targeted literature review was conducted in PubMed, MEDLINE, Embase, and the Cochrane Database of Systematic Reviews (1995-2019) to identify data on the epidemiology, management, and humanistic and economic burden of dry AMD in adults. A landscape analysis of...
Source: Clinical Therapeutics - Category: Drugs & Pharmacology Authors: Source Type: research
People with macular degeneration, cataracts and diabetes-related eye disease at greater riskMillions of people with eye conditions including age-related macular degeneration, cataracts and diabetes-related eye disease have an increased risk of developing dementia, new research shows.Vision impairment can be one of the first signs of the disease, which is predicted to affect more than 130 million people worldwide by 2050.Continue reading...
Source: Guardian Unlimited Science - Category: Science Authors: Tags: Medical research Health Dementia Blindness and visual impairment Society Source Type: news
Aging (Albany NY). 2021 Sep 8;13(undefined). doi: 10.18632/aging.203496. Online ahead of print.ABSTRACTThe senescence of retinal pigment epithelial (RPE) cells is associated with age-related macular degeneration (AMD), a leading cause of blindness in the world. HSP90 is a predominant chaperone that regulates cellular homeostasis under divergent physio-pathological conditions including senescence. However, the role of HSP90 in senescent RPE cells still remains unclear. Here, we reported that HSP90 acts as a senomorphic target of senescent RPE cells in vitro. Using H2O2-induced senescent ARPE-19 cells and replicative senesce...
Source: Aging - Category: Biomedical Science Authors: Source Type: research
CONCLUSIONS: These data further support ox-elastin role in ocular damage in in part via elastin-specific antibodies, and support the corollary that PIT with ox-elastin attenuates ocular pathology. Overall, damage is associated with complement activation, antibody-dependent cell-mediated cytotoxicity, and altered cytokine signature.PMID:34487725 | DOI:10.1016/j.exer.2021.108755
Source: Experimental Eye Research - Category: Opthalmology Authors: Source Type: research
AbstractAge-related macular degeneration (AMD) is a progressive, degenerative disease of the human retina which in its most aggressive form is associated with the formation of macular neovascularization (MNV) and subretinal fibrosis leading to irreversible blindness. MNVs contain blood vessels as well as infiltrating immune cells, myofibroblasts, and excessive amounts of extracellular matrix proteins such as collagens, fibronectin, and laminin which disrupts retinal function and triggers neurodegeneration. In the mammalian retina, damaged neurons cannot be replaced by tissue regeneration, and subretinal MNV and fibrosis pe...
Source: Cell and Tissue Research - Category: Cytology Source Type: research
This study investigated the association between ambient air pollution and AMD in 15,115 middle-aged and older adults (≥40 years) from Korean National Health and Nutrition Examination Survey 2008-2012. After controlling for important confounders, ambient NO2 and CO in current-to-5 prior years and PM10 in 2-to-5 prior years were significantly associated with higher prevalence of early AMD, while O3 in current-to-5 prior years was significantly associated with lower prevalence of early AMD. When modeled air pollution within administrative division units, its ORs with an IQR increase in NO2, CO, and O3 at current year were ...
Source: Environmental Research - Category: Environmental Health Authors: Source Type: research
ConclusionThis systematic review supports the use of structural and functional biomarkers in early AMD and intermediate AMD, which are more reproducible and less invasive than the other classes of biomarkers described. The use of deep learning and combinational algorithms will gain increasing importance in future clinical trials of nonexudative AMD.
Source: Molecular Diagnosis and Therapy - Category: Molecular Biology Source Type: research
The choriocapillaris and RPE share a close relationship in the photoreceptor/RPE/Bruch's membrane (BM)/choriocapillaris complex.1 Disruption of the relationship between the choriocapillaris, RPE and photoreceptors has been observed in histological specimens of patients with age-related macular degeneration (AMD)2-4, which may result in geographic atrophy (GA), a leading cause of blindness in patients with age-related macular degeneration (AMD).1 GA results in reduced macular sensitivity from loss of RPE and photoreceptors in GA regions5, 6.
Source: American Journal of Ophthalmology - Category: Opthalmology Authors: Source Type: research
ConclusionThe findings highlight the importance and need for regular eye screening and diabetes prevention programs in the country. Continuous educational programs on diabetes self-management among patients with DM can reduce complications of diabetes including vision loss due to diabetes.
Source: International Ophthalmology - Category: Opthalmology Source Type: research
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