Cargando…

Ranibizumab port delivery system: a clinical perspective

Age-related macular degeneration (AMD) represents a leading cause of blindness worldwide. Neovascular AMD (nAMD) is a subtype of AMD most frequently treated with intravitreal anti-vascular endothelial growth factor (aVEGF) injections, which has allowed for patients to maintain vision that would have...

Descripción completa

Detalles Bibliográficos
Autores principales: Eichenbaum, David A, Ahmed, Abrahim, Hiya, Farhan
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9516155/
https://www.ncbi.nlm.nih.gov/pubmed/36161829
http://dx.doi.org/10.1136/bmjophth-2022-001104
_version_ 1784798647653761024
author Eichenbaum, David A
Ahmed, Abrahim
Hiya, Farhan
author_facet Eichenbaum, David A
Ahmed, Abrahim
Hiya, Farhan
author_sort Eichenbaum, David A
collection PubMed
description Age-related macular degeneration (AMD) represents a leading cause of blindness worldwide. Neovascular AMD (nAMD) is a subtype of AMD most frequently treated with intravitreal anti-vascular endothelial growth factor (aVEGF) injections, which has allowed for patients to maintain vision that would have otherwise been lost. However, the need for frequent intravitreal injections for optimal results poses a risk for undertreatment in nAMD patients due to the high treatment burden associated with current aVEGF therapy. Many novel agents and pathways are being explored and targeted for less burdensome treatment options, one of which is the ranibizumab port delivery system (PDS). The PDS is a surgically implanted, refillable device that allows for the sustained release of ranibizumab, a widely used aVEGF agent, into the vitreous cavity. Positive results non-inferior to monthly ranibizumab injections in both phase II and phase III clinical trials allowed for FDA approval of the device with refill intervals of 6 months, which represents the longest approved treatment interval to date for nAMD therapy. This article reviews the need for a durable nAMD treatment option in real-world practice, the clinical trial and extension study data for the PDS, the risk of adverse events and safety profile of the PDS and the potential clinical role of the PDS in answering the real-world needs of nAMD treatment. In addition, other pipeline sustained-treatment modalities are discussed in the context of ongoing clinical trials.
format Online
Article
Text
id pubmed-9516155
institution National Center for Biotechnology Information
language English
publishDate 2022
publisher BMJ Publishing Group
record_format MEDLINE/PubMed
spelling pubmed-95161552022-09-29 Ranibizumab port delivery system: a clinical perspective Eichenbaum, David A Ahmed, Abrahim Hiya, Farhan BMJ Open Ophthalmol Review Age-related macular degeneration (AMD) represents a leading cause of blindness worldwide. Neovascular AMD (nAMD) is a subtype of AMD most frequently treated with intravitreal anti-vascular endothelial growth factor (aVEGF) injections, which has allowed for patients to maintain vision that would have otherwise been lost. However, the need for frequent intravitreal injections for optimal results poses a risk for undertreatment in nAMD patients due to the high treatment burden associated with current aVEGF therapy. Many novel agents and pathways are being explored and targeted for less burdensome treatment options, one of which is the ranibizumab port delivery system (PDS). The PDS is a surgically implanted, refillable device that allows for the sustained release of ranibizumab, a widely used aVEGF agent, into the vitreous cavity. Positive results non-inferior to monthly ranibizumab injections in both phase II and phase III clinical trials allowed for FDA approval of the device with refill intervals of 6 months, which represents the longest approved treatment interval to date for nAMD therapy. This article reviews the need for a durable nAMD treatment option in real-world practice, the clinical trial and extension study data for the PDS, the risk of adverse events and safety profile of the PDS and the potential clinical role of the PDS in answering the real-world needs of nAMD treatment. In addition, other pipeline sustained-treatment modalities are discussed in the context of ongoing clinical trials. BMJ Publishing Group 2022-09-26 /pmc/articles/PMC9516155/ /pubmed/36161829 http://dx.doi.org/10.1136/bmjophth-2022-001104 Text en © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) .
spellingShingle Review
Eichenbaum, David A
Ahmed, Abrahim
Hiya, Farhan
Ranibizumab port delivery system: a clinical perspective
title Ranibizumab port delivery system: a clinical perspective
title_full Ranibizumab port delivery system: a clinical perspective
title_fullStr Ranibizumab port delivery system: a clinical perspective
title_full_unstemmed Ranibizumab port delivery system: a clinical perspective
title_short Ranibizumab port delivery system: a clinical perspective
title_sort ranibizumab port delivery system: a clinical perspective
topic Review
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9516155/
https://www.ncbi.nlm.nih.gov/pubmed/36161829
http://dx.doi.org/10.1136/bmjophth-2022-001104
work_keys_str_mv AT eichenbaumdavida ranibizumabportdeliverysystemaclinicalperspective
AT ahmedabrahim ranibizumabportdeliverysystemaclinicalperspective
AT hiyafarhan ranibizumabportdeliverysystemaclinicalperspective