End-of-Study Results for the Ladder Phase 2 Trial of the Port Delivery System with Ranibizumab for Neovascular Age-Related Macular Degeneration

Khanani, Arshad M.; Callanan, David; Dreyer, Richard F.; Chen, Sanford; Howard, J. G.; Hopkins, J Jill; Lin, Chin-Yu; Lorenz-Candlin, Meike; Makadia, Sneha; Patel, Shienal; Tam, Tammy; Gune, Shamika

doi:10.1016/j.oret.2020.11.004

Cited by 58 publications

(102 citation statements)

References 31 publications

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“…The RPDS is a surgically implanted refillable reservoir that continuously delivers ranibizumab to the vitreous cavity. A phase 3 clinical study is ongoing (ClinicalTrials.gov: NCT03677934), but earlier studies have demonstrated its safety with comparable visual acuity and macular thickness results to IVR therapy in the treatment of eAMD [ 170 , 171 ]. This technology’s capacity to continuously deliver anti-VEGF may be paramount to overcoming anti-VEGF resistance in all the previously discussed diseases.…”

Section: Future Considerations—ranibizumab Port Delivery Systemmentioning

confidence: 99%

Anti-VEGF-Resistant Retinal Diseases: A Review of the Latest Treatment Options

Wallsh

Gallemore

2021

Cells

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Anti-vascular endothelial growth factor (anti-VEGF) therapy currently plays a central role in the treatment of numerous retinal diseases, most notably exudative age-related macular degeneration (eAMD), diabetic retinopathy and retinal vein occlusions. While offering significant functional and anatomic benefits in most patients, there exists a subset of 15–40% of eyes that fail to respond or only partially respond. For these cases, various treatment options have been explored with a range of outcomes. These options include steroid injections, laser treatment (both thermal therapy for retinal vascular diseases and photodynamic therapy for eAMD), abbreviated anti-VEGF treatment intervals, switching anti-VEGF agents and topical medications. In this article, we review the effectiveness of these treatment options along with a discussion of the current research into future directions for anti-VEGF-resistant eyes.

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Section: Future Considerations—ranibizumab Port Delivery Systemmentioning

confidence: 99%

Anti-VEGF-Resistant Retinal Diseases: A Review of the Latest Treatment Options

Wallsh

Gallemore

2021

Cells

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“…Maintaining a BCVA of 20/40 over a mean of 2 years akin to monthly intravitreal ranibizumab group clearly shows that the PDS system can reduce treatment burden without compromising clinical benefit. 20 , 21 , 25 , 29…”

Section: Discussionmentioning

confidence: 99%

“…Pharmacokinetic profile with well-maintained pharmacological concentrations of this drug was good enough to maintain BCVA for a long period. 20 , 21 , 25 , 29…”

Section: Discussionmentioning

confidence: 99%

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Ranibizumab port delivery system in neovascular age-related macular degeneration

Chandrasekaran¹,

Madanagopalan

2022

Ophthalmol Eye Dis

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Ranibizumab has proven its efficacy in various retinal diseases and particularly in neovascular age-related macular degeneration (nAMD). The number of injections and the frequent follow-up visits has been burdensome to patients particularly during the COVID era. Ranibizumab port delivery system (RPDS) seems to be a boon in prolonging the action of the drug without the need for frequent injections and follow-up visits. This review article highlights the dosage, adverse effects, and visual outcome associated with various trials of RPDS. For this article, we conducted a PubMed search and review of literature on nAMD, the incidence of AMD, anti-vascular endothelial growth factor (anti-VEGF) agents, RPDS, phase-1 trial of RPDS, phase-2 (LADDER trial) of RPDS, phase-3 (ARCHWAY trial) of RPDS, PORTAL trial of RPDS, results of phase-1 trial of RPDS, results of phase-2 (LADDER) trial of RPDS, and results of phase-3 (ARCHWAY) trial of RPDS.

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“…Some of these systems are currently being translated for commercial use, such as ReVana Therapeutics' EyeLief TM and OcuLief TM injectable polymers (231). One system with particularly promising results is the Genentech Port Delivery System, SUSVIMO TM a reloadable port composed of a polysulfone body coated in silicone, which recently received FDA approval for delivery of ranibizumab for the treatment of wet AMD (232,233). Figure 5 contains a schematic of some of the FDA approved polymeric biomaterial products and administration location.…”

Section: Intravitreal Injections and Implantsmentioning

confidence: 99%

Considerations for Polymers Used in Ocular Drug Delivery

et al. 2022

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PurposeAge-related eye diseases are becoming more prevalent. A notable increase has been seen in the most common causes including glaucoma, age-related macular degeneration (AMD), and cataract. Current clinical treatments vary from tissue replacement with polymers to topical eye drops and intravitreal injections. Research and development efforts have increased using polymers for sustained release to the eye to overcome treatment challenges, showing promise in improving drug release and delivery, patient experience, and treatment compliance. Polymers provide unique properties that allow for specific engineered devices to provide improved treatment options. Recent work has shown the utilization of synthetic and biopolymer derived biomaterials in various forms, with this review containing a focus on polymers Food and Drug Administration (FDA) approved for ocular use.MethodsThis provides an overview of some prevalent synthetic polymers and biopolymers used in ocular delivery and their benefits, brief discussion of the various types and synthesis methods used, and administration techniques. Polymers approved by the FDA for different applications in the eye are listed and compared to new polymers being explored in the literature. This article summarizes research findings using polymers for ocular drug delivery from various stages: laboratory, preclinical studies, clinical trials, and currently approved. This review also focuses on some of the challenges to bringing these new innovations to the clinic, including limited selection of approved polymers.ResultsPolymers help improve drug delivery by increasing solubility, controlling pharmacokinetics, and extending release. Several polymer classes including synthetic, biopolymer, and combinations were discussed along with the benefits and challenges of each class. The ways both polymer synthesis and processing techniques can influence drug release in the eye were discussed.ConclusionThe use of biomaterials, specifically polymers, is a well-studied field for drug delivery, and polymers have been used as implants in the eye for over 75 years. Promising new ocular drug delivery systems are emerging using polymers an innovative option for treating ocular diseases because of their tunable properties. This review touches on important considerations and challenges of using polymers for sustained ocular drug delivery with the goal translating research to the clinic.

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End-of-Study Results for the Ladder Phase 2 Trial of the Port Delivery System with Ranibizumab for Neovascular Age-Related Macular Degeneration

Cited by 58 publications

References 31 publications

Anti-VEGF-Resistant Retinal Diseases: A Review of the Latest Treatment Options

Anti-VEGF-Resistant Retinal Diseases: A Review of the Latest Treatment Options

Ranibizumab port delivery system in neovascular age-related macular degeneration

Considerations for Polymers Used in Ocular Drug Delivery

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