Susvimo (ranibizumab port delivery system) / Roche - LARVOL DELTA

Ranibizumab port delivery system for neovascular age-related macular degeneration: Current evidence and surgical considerations. (PubMed, Graefes Arch Clin Exp Ophthalmol) - "The ranibizumab PDS establishes sustained intraocular anti-VEGF delivery as a viable alternative to anti-VEGF injections especially in patients requiring frequent dosing. Its long-term role will depend on optimization of surgical workflows, management of implant-specific risks, integration of monitoring strategies, and ongoing refinement of device design to support scalable, durable retinal care."

Journal • Review • Age-related Macular Degeneration • Hematological Disorders • Macular Degeneration • Ocular Infections • Ocular Inflammation • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

European Commission approves Roche’s Susvimo for the treatment of neovascular age-related macular degeneration (nAMD) (GlobeNewswire) - "The approval is based on data from three clinical studies in nAMD: one pivotal Phase III study, Archway, and two supportive studies, the Phase II Ladder study and the open-label long-term extension study Portal."

EMA approval • Wet Age-related Macular Degeneration

Visualization Techniques for Port Delivery System Refill-Exchange. (PubMed, J Vitreoretin Dis) - "To describe methods for improving visualization of the port delivery system (PDS) with ranibizumab (Susvimo) during the refill-exchange procedure when visualization of the implant septum is compromised...Transpupillary and transscleral illumination of the PDS reservoir body using various light sources improved visualization of the implant septum during the refill-exchange procedure. Indirect internal illumination of the PDS implant can facilitate visualization of the implant septum during the refill-exchange procedure, particularly when visualization is compromised by conjunctival edema, thickened Tenon capsule, or fibrous capsule formation."

Journal

Biomaterials in Retinal Surgery: Engineering the Future. (PubMed, Am J Ophthalmol) - "Biomaterial engineering is transforming retinal disease management from stabilization toward tissue replacement and vision restoration. Principal limitations are the preclinical status of the hydrogel data and early-phase status of RPE scaffold trials. Outstanding challenges include long-term in vivo stability, immunological management of allogeneic constructs, scalable manufacturing, and definitive efficacy trials."

Journal • Review • Age-related Macular Degeneration • Diabetic Retinopathy • Dry Age-related Macular Degeneration • Gene Therapies • Ophthalmology • Retinal Disorders • Transplantation

CHMP recommends EU approval of Roche’s Susvimo, the first continuous delivery treatment for neovascular age-related macular degeneration (nAMD) (GlobeNewswire) - "The positive recommendation is based on data from three clinical studies in nAMD: one pivotal Phase III study, Archway, and two supportive studies, the Phase II LADDER study and the open-label long-term extension study Portal."

CHMP • Age-related Macular Degeneration

Pagoda: A Study to Evaluate Efficacy, Safety & Pharmacokinetics of the Port Delivery System (PDS) With Ranibizumab in Participants With Diabetic Macular Edema (DME) Compared With Intravitreal Ranibizumab; A Substudy to Evaluate the Safety of Re-implanting the PDS With Ranibizumab in Participants With DME (clinicaltrials.gov) - P3 | N=672 | Active, not recruiting | Sponsor: Hoffmann-La Roche | Trial completion date: Nov 2027 ➔ Jul 2027 | Trial primary completion date: Nov 2027 ➔ Jul 2027

Trial completion date • Trial primary completion date • Diabetic Macular Edema • Ophthalmology

A Study Of The Efficacy, Safety, And Pharmacokinetics Of The Port Delivery System With Ranibizumab In Chinese Patients With Neovascular Age-Related Macular Degeneration (clinicaltrials.gov) - P3 | N=68 | Not yet recruiting | Sponsor: Hoffmann-La Roche | Trial completion date: Jun 2027 ➔ May 2029 | Trial primary completion date: Jun 2025 ➔ Feb 2027

Trial completion date • Trial primary completion date • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

A Study Of The Efficacy, Safety, And Pharmacokinetics Of The Port Delivery System With Ranibizumab In Chinese Patients With Neovascular Age-Related Macular Degeneration (clinicaltrials.gov) - P3 | N=68 | Not yet recruiting | Sponsor: Hoffmann-La Roche | Initiation date: Oct 2022 ➔ Feb 2023

Trial initiation date • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

A Study Of The Efficacy, Safety, And Pharmacokinetics Of The Port Delivery System With Ranibizumab In Chinese Patients With Neovascular Age-Related Macular Degeneration (clinicaltrials.gov) - P3 | N=68 | Recruiting | Sponsor: Hoffmann-La Roche | Not yet recruiting ➔ Recruiting

Enrollment open • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

A Study of the Efficacy, Safety, and Pharmacokinetics (PK) of the Port Delivery System With Ranibizumab (PDS) in Chinese Participants With Neovascular Age-related Macular Degeneration (nAMD) (clinicaltrials.gov) - P3 | N=68 | Recruiting | Sponsor: Hoffmann-La Roche | Trial completion date: May 2029 ➔ Aug 2029

Trial completion date • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

A Study Of The Efficacy, Safety, And Pharmacokinetics Of The Port Delivery System With Ranibizumab In Chinese Patients With Neovascular Age-Related Macular Degeneration (clinicaltrials.gov) - P3 | N=68 | Recruiting | Sponsor: Hoffmann-La Roche | Trial primary completion date: Feb 2027 ➔ Feb 2025

Trial primary completion date • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

A Study Of The Efficacy, Safety, And Pharmacokinetics Of The Port Delivery System With Ranibizumab In Chinese Patients With Neovascular Age-Related Macular Degeneration (clinicaltrials.gov) - P3 | N=68 | Recruiting | Sponsor: Hoffmann-La Roche

New P3 trial • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

A Study Of The Efficacy, Safety, And Pharmacokinetics Of The Port Delivery System With Ranibizumab In Chinese Patients With Neovascular Age-Related Macular Degeneration (clinicaltrials.gov) - P3 | N=68 | Not yet recruiting | Sponsor: Hoffmann-La Roche | Initiation date: Dec 2023 ➔ May 2024

Trial initiation date • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

A Study Of The Efficacy, Safety, And Pharmacokinetics Of The Port Delivery System With Ranibizumab In Chinese Patients With Neovascular Age-Related Macular Degeneration (clinicaltrials.gov) - P3 | N=68 | Recruiting | Sponsor: Hoffmann-La Roche | Trial primary completion date: Feb 2027 ➔ Jun 2027

Trial primary completion date • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

A Study Of The Efficacy, Safety, And Pharmacokinetics Of The Port Delivery System With Ranibizumab In Chinese Patients With Neovascular Age-Related Macular Degeneration (clinicaltrials.gov) - P3 | N=68 | Not yet recruiting | Sponsor: Hoffmann-La Roche | Trial completion date: Feb 2027 ➔ Jun 2027 | Trial primary completion date: Feb 2025 ➔ Jun 2025

Trial completion date • Trial primary completion date • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

A Study Of The Efficacy, Safety, And Pharmacokinetics Of The Port Delivery System With Ranibizumab In Chinese Patients With Neovascular Age-Related Macular Degeneration (clinicaltrials.gov) - P3 | N=68 | Not yet recruiting | Sponsor: Hoffmann-La Roche | Initiation date: Feb 2023 ➔ Dec 2023

Trial initiation date • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Port Delivery System Vs Monthly Ranibizumab in VEGF-Driven Macular Disease: A Systematic Review and Meta-Analysis. (PubMed, Semin Ophthalmol) - "Evidence in DME was limited to a single trial, and conclusions in this population should be considered exploratory. PDS was associated with a higher incidence of procedure- and device-related ocular complications."

Journal • Retrospective data • Review • Age-related Macular Degeneration • Diabetic Macular Edema • Hematological Disorders • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Next-Generation Drug Delivery for Age-related Macular Degeneration: Promise of Controlled Release Formulations. (PubMed, Drug Dev Ind Pharm) - "Next-generation long-acting ocular drug delivery systems have the potential to transform nAMD management by reducing invasive procedures, improving patient adherence, and maintaining durable therapeutic efficacy. Continued optimization and clinical translation of these technologies are essential for their successful integration into routine ophthalmic care."

Journal • Review • Age-related Macular Degeneration • Gene Therapies • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Pagoda: A Study to Evaluate Efficacy, Safety & Pharmacokinetics of the Port Delivery System (PDS) With Ranibizumab in Participants With Diabetic Macular Edema (DME) Compared With Intravitreal Ranibizumab; A Substudy to Evaluate the Safety of Re-implanting the PDS With Ranibizumab in Participants With DME (clinicaltrials.gov) - P3 | N=634 | Active, not recruiting | Sponsor: Hoffmann-La Roche | Recruiting ➔ Active, not recruiting

Enrollment closed • Diabetic Macular Edema • Ophthalmology

Effectiveness and Safety of Susvimo (Ranibizumab Port Delivery System) in Diabetic Retinopathy and Diabetic Macular Edema: A Systematic Review and Meta-analysis. (PubMed, Eur J Pharmacol) - "Ranibizumab PDS demonstrates sustained functional and DR-severity benefits, low supplemental-treatment requirements, and largely manageable procedure-related adverse events over the reported follow-up periods; however, longer-term and real-world safety data remain necessary."

Journal • Retrospective data • Review • Diabetic Macular Edema • Diabetic Retinopathy • Ocular Infections • Ocular Inflammation • Ophthalmology • Retinal Disorders

Real-world durability challenges with nAMD treatments and the potential promise of gene therapy. (PubMed, Curr Med Res Opin) - "Emerging longer-acting strategies include continuous-release delivery systems (e.g. ranibizumab port delivery system) and gene therapy...Emerging patterns of retreatment support the concept that supplemental treatment does not necessarily indicate waning efficacy, but rather the adjuvant treatment may be used transiently to fine tune for increased disease activity levels at the patient level. In summary, multiple factors need to be considered to understand the durability of future therapies, not only reduced procedural frequency but also continuous disease control and improved quality of life - key metrics that will guide the evolution of care in nAMD."

Journal • Real-world evidence • Age-related Macular Degeneration • Gene Therapies • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Belvedere: A Study Assessing Corneal Endothelial Cells in Participants With Neovascular Age-related Macular Degeneration (nAMD) Treated With the Port Delivery System With Ranibizumab (PDS) (clinicaltrials.gov) - P4 | N=188 | Recruiting | Sponsor: Genentech, Inc. | Trial completion date: Apr 2028 ➔ Oct 2027 | Trial primary completion date: Mar 2028 ➔ Sep 2027

Trial completion date • Trial primary completion date • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Model-based pharmacokinetic simulations of the Port Delivery Platform with ranibizumab (PDS) under various real-world clinical scenarios (ARVO 2026) - "Variability in individual ocular half-life was predicted to shift absolute vitreous concentrations but not change the fundamental vitreous PK profile shape, which was dictated by the implant release rate. Conclusions Model-based simulations demonstrated that PDS 100 mg/mL every 24 or 36 weeks provides continuous ocular ranibizumab exposure within the established safe and efficacious exposure range of monthly IVT ranibizumab 0.5 mg injections, supporting understanding of PDS PK across real-world clinical scenarios."

Clinical • PK/PD data • Real-world • Real-world evidence • Age-related Macular Degeneration • Diabetic Macular Edema • Diabetic Retinopathy • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Real-World Efficacy and Safety of the Ranibizumab Port-Delivery System in Neovascular AMD: First-Time 3 Year Results of the SUMMIT Study (ARVO 2026) - "Three patients required rescue injection with aflibercept or faricimab, one due to no refill supply. Future results will continue to investigate the long-term safety and efficacy of PDS in real-world patients with nAMD. First-time longer-term data will be presented at ARVO 2026."

Clinical • Real-world • Real-world effectiveness • Real-world evidence • Age-related Macular Degeneration • Macular Degeneration • Ocular Infections • Ocular Inflammation • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Ranibizumab Port Delivery System vs Monthly Injections in VEGF-Driven Macular Disease: A Meta-Analysis of Phase 2 and 3 Randomized Controlled Trials (ARVO 2026) - "However, patients using the PDS experienced higher rates of certain eye complications, such as bleeding or problems with the surface tissue of the eye, compared with those receiving monthly treatments. These results suggest that the PDS may offer a more convenient alternative for people who struggle with frequent injections, but its potential risks should be weighed against its benefits when choosing a treatment approach."

P2 data • Retrospective data • Age-related Macular Degeneration • Diabetic Macular Edema • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration