Ranibizumab port delivery system in neovascular age-related macular degeneration

Chandrasekaran, Priya R; Madanagopalan, V G

doi:10.1177/25158414211072623

Cited by 6 publications

(4 citation statements)

References 28 publications

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“…In October of 2022, Genentech voluntarily withdrew the PDS from the market because of septal dislodgement [94]. The company is redesigning the septum and is hoping to reintroduce the PDS in late 2024 [95].…”

Section: Ranibizumab Port Delivery Systemmentioning

confidence: 99%

Extended Duration Anti-VEGF Therapy for Chorioretinal Vascular Diseases: Successes, Failures and Challenges

Hasan,

Miller,

Stewart

2023

Preprint

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Pathologic angiogenesis is responsible for much of the vision loss that stems from several chorioretinal vascular diseases including neovascular age-related macular degeneration (nAMD), diabetic retinopathy (DR), and retinal vein occlusion (RVO). Because vascular endothelial growth factor (VEGF) serves as a pivotal angiogenic molecule, it has emerged as the primary target for therapeutic drugs. Current anti-VEGF therapy is dominated by bevacizumab, ranibizumab, and aflibercept, all of which have been available for more than a decade, but new drugs, both biosimilars (Byooviz and Cimerli) and drugs whose primary aim is to decrease treatment burden (brolucizumab, faricimab, and the ranibizumab port delivery system), have been approved. Recent failures (conbercept, abicipar, and KSI-301) emphasize the complexity of drug development and the difficulties faced by innovators. Most therapies under development, including tyrosine kinase inhibitors and gene therapy, include VEGF-A blockade as their primary function and aim to extend durability rather than increase peak efficacy. But even as many new drugs look to extend durability, cost containment with mandated use of biosimilars serves to balance the therapeutic landscape.

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Section: Ranibizumab Port Delivery Systemmentioning

confidence: 99%

Extended Duration Anti-VEGF Therapy for Chorioretinal Vascular Diseases: Successes, Failures and Challenges

Hasan,

Miller,

Stewart

2023

Preprint

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“…39 Alongside this, a study by Chandrasekaran et al supported the long-term biocompatibility of the PDS and its non-inflammatory and non-toxic nature. 40 Other sustained release/long-duration treatments in development Alongside the ranibizumab PDS, innovative drugs and novel treatment modalities in the pipeline aim to further prolong treatment intervals via novel delivery or by targeting novel pathways implicated in nAMD pathology, including tyrosine kinase inhibitors, aVEGF biopolymers, ANG-2 inhibitors, TIE-2 inhibitors, integrin inhibitors, and gene therapies. 41 Alternative Open access sustained-release treatments targeting the tyrosine kinase pathway currently in development include GB-102 (Sunitinib maleate; GrayBug Vision, Redwood City, California, USA) and Durasert Bioerodible TKI (Durasert; EyePoint Pharmaceuticals, Watertown, Massachusetts, USA).…”

Section: Risks and Benefits Of The Pdsmentioning

confidence: 99%

“…Finally, the selection of ranibizumab as the deliverable agent may optimise the PDS’s effectiveness as well as adoption into clinical practice for nAMD as well as other diseases such as diabetic retinopathy and branch retinal vein occlusion as ranibizumab is a widely established, effective, and well-tolerated aVEGF drug already used to treat such patients 39. Alongside this, a study by Chandrasekaran et al supported the long-term biocompatibility of the PDS and its non-inflammatory and non-toxic nature 40…”

Section: Introductionmentioning

confidence: 97%

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Ranibizumab port delivery system: a clinical perspective

Eichenbaum

Ahmed

Hiya³

2022

BMJ Open Ophth

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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.

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Injectable Polymer‐Nanoparticle Hydrogel for the Sustained Intravitreal Delivery of Bimatoprost

Meany

Andaya²,

Tang³

et al. 2022

Advanced Therapeutics

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Vision impairment resulting from chronic eye diseases, such as macular degeneration and glaucoma, severely impacts patients' quality of life and poses an immense global financial burden. Current standard of care for such diseases includes daily eye drops or frequent intravitreal (ITV) injections, which are burdensome treatment modalities resulting in low patient compliance. There remains a growing need for easily administered long-acting delivery technologies for prolonging exposure of ocular therapeutics with each administration. Here, this work deploys a supramolecular polymer-nanoparticle (PNP) hydrogel for ITV delivery of the glaucoma drug bimatoprost. PNP hydrogels are shear-thinning and self-healing, key properties for injectability, and enable slow release of molecular cargo in vitreous humor (VH) mimics. An in vivo study in New Zealand white rabbits demonstrated intravitreally injected PNP hydrogels form depots that degrade slowly over time, maintaining detectable levels of bimatoprost in the VH up to 8 weeks following injection. Ophthalmic examinations and histopathology identified a mild foreign body response (FBR) to the hydrogel, characterized by rare clusters of foamy macrophages and giant cells associated with minimal, patchy fibroplasia. This work shows that PNP hydrogels exhibit numerous desirable traits for sustained drug delivery and further work will be necessary to optimize tolerability in the eye.

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Ranibizumab port delivery system in neovascular age-related macular degeneration

Cited by 6 publications

References 28 publications

Extended Duration Anti-VEGF Therapy for Chorioretinal Vascular Diseases: Successes, Failures and Challenges

Extended Duration Anti-VEGF Therapy for Chorioretinal Vascular Diseases: Successes, Failures and Challenges

Ranibizumab port delivery system: a clinical perspective

Injectable Polymer‐Nanoparticle Hydrogel for the Sustained Intravitreal Delivery of Bimatoprost

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