Age-related macular degeneration (AMD) is the leading cause of irreversible blindness in the developed world, posing a huge healthcare and societal burden. The impact of AMD will only grow as the population continues to age and the number of patients with AMD increases to an expected 228 million worldwide by 2040.[1]
Significant strides have been made over the past decade in the treatment of neovascular AMD (nAMD), with intravitreal anti–vascular endothelial growth factor (anti-VEGF) therapy proven in numerous studies to be highly effective in preventing further vision loss in most patients and improving vision in many. However, there remains a significant financial and societal burden centered around the frequency of visits needed for continued intravitreal anti-VEGF therapy. For years, researchers have explored the possibility of longer-acting options.
The Port Delivery System (PDS) is a permanent, surgically implanted, refillable intravitreal implant designed to deliver a continuous supply of ranibizumab into the vitreous. The Ladder trial was a phase 2 study that established the efficacy of the 100 mg/mL formulation of ranibizumab as well as an acceptable safety profile of the PDS system.[2]
Phase 3 Trial Demonstrates Noninferior Outcomes
Recently, the phase 3 Archway trial[3]evaluated the safety and efficacy of the PDS with ranibizumab compared with traditional monthly intravitreal ranibizumab injections.
COMMENTARY
Into the Future: Long-Term Anti-VEGF Delivery System Draws Closer to Primetime
Ali R. Salman, MD; Sophie J. Bakri, MD
DisclosuresApril 20, 2022
Age-related macular degeneration (AMD) is the leading cause of irreversible blindness in the developed world, posing a huge healthcare and societal burden. The impact of AMD will only grow as the population continues to age and the number of patients with AMD increases to an expected 228 million worldwide by 2040.[1]
Significant strides have been made over the past decade in the treatment of neovascular AMD (nAMD), with intravitreal anti–vascular endothelial growth factor (anti-VEGF) therapy proven in numerous studies to be highly effective in preventing further vision loss in most patients and improving vision in many. However, there remains a significant financial and societal burden centered around the frequency of visits needed for continued intravitreal anti-VEGF therapy. For years, researchers have explored the possibility of longer-acting options.
The Port Delivery System (PDS) is a permanent, surgically implanted, refillable intravitreal implant designed to deliver a continuous supply of ranibizumab into the vitreous. The Ladder trial was a phase 2 study that established the efficacy of the 100 mg/mL formulation of ranibizumab as well as an acceptable safety profile of the PDS system.[2]
Phase 3 Trial Demonstrates Noninferior Outcomes
Recently, the phase 3 Archway trial[3]evaluated the safety and efficacy of the PDS with ranibizumab compared with traditional monthly intravitreal ranibizumab injections.
Credits:
Lead image: Genentech
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Cite this: Ali R. Salman, Sophie J. Bakri. Into the Future: Long-Term Anti-VEGF Delivery System Draws Closer to Primetime - Medscape - Apr 20, 2022.
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Authors and Disclosures
Authors and Disclosures
Author(s)
Ali R. Salman, MD
Ophthalmology Resident, Mayo Clinic, Rochester, Minnesota
Disclosure: Ali R. Salman, MD, has disclosed no relevant financial relationships.
Sophie J. Bakri, MD
Professor, Department of Ophthalmology, Mayo Clinic, Rochester, Minnesota
Disclosure: Sophie J. Bakri, MD, has disclosed no relevant financial relationships.