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

Chugai Pharmaceutical Co., Ltd…announced that it filed a regulatory application with the Ministry of Health, Labour and Welfare (MHLW) for the medical device component (implant and ancillary devices; hereafter, the “ocular implant”) of the Port Delivery Platform with ranibizumab when used in combination with of ranibizumab. (Chugai Press Release) - "The application is based on the results from the global Phase III Archway study in patients with neovascular age-related macular degeneration (nAMD), and the global Phase III Pagoda study in patients with diabetic macular edema (DME), both conducted in the US by Roche/Genentech....A regulatory filing for the drug product is planned in 2026 and is expected to include results from the domestic Phase I/II TEIEN study in patients with nAMD and DME, in addition to the Archway and Pagoda studies."

Japan filing • Age-related Macular Degeneration • Diabetic Macular Edema

VOYAGER: A Real-World Study to Gain Clinical Insights Into Roche Ophthalmology Products (clinicaltrials.gov) - P=N/A | N=6000 | Active, not recruiting | Sponsor: Hoffmann-La Roche | Trial primary completion date: Mar 2027 ➔ Nov 2026

Real-world evidence • Trial primary completion date • Age-related Macular Degeneration • Diabetic Macular Edema • Macular Degeneration • Ophthalmology • Retinal Disorders • Retinal Vein Occlusion • Wet Age-related Macular Degeneration

Extension Study for the Port Delivery System With Ranibizumab (Portal) (clinicaltrials.gov) - P3 | N=1000 | Recruiting | Sponsor: Hoffmann-La Roche | Trial completion date: Dec 2026 ➔ Sep 2029 | Trial primary completion date: Dec 2026 ➔ Sep 2029

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

Extension Study for the Port Delivery System With Ranibizumab (Portal) (clinicaltrials.gov) - P3 | N=500 | Recruiting | Sponsor: Hoffmann-La Roche | Trial completion date: Jun 2022 ➔ Jan 2022 | Trial primary completion date: Jun 2022 ➔ Mar 2020

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

Extension Study for the Port Delivery System With Ranibizumab (Portal) (clinicaltrials.gov) - P3 | N=1000 | Recruiting | Sponsor: Hoffmann-La Roche | N=500 ➔ 1000 | Trial completion date: Apr 2022 ➔ Sep 2025 | Trial primary completion date: Apr 2022 ➔ Sep 2025

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

Extension Study for the Port Delivery System With Ranibizumab (Portal) (clinicaltrials.gov) - P3 | N=1000 | Recruiting | Sponsor: Hoffmann-La Roche | Trial completion date: Sep 2025 ➔ Jul 2026 | Trial primary completion date: Sep 2025 ➔ Jul 2026

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

Extension Study for the Port Delivery System With Ranibizumab (Portal) (clinicaltrials.gov) - P3 | N=500 | Recruiting | Sponsor: Hoffmann-La Roche

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

Extension Study for the Port Delivery System With Ranibizumab (Portal) (clinicaltrials.gov) - P3 | N=1000 | Recruiting | Sponsor: Hoffmann-La Roche | Trial completion date: Jul 2026 ➔ Dec 2026 | Trial primary completion date: Jul 2026 ➔ Dec 2026

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

Extension Study for the Port Delivery System With Ranibizumab (Portal) (clinicaltrials.gov) - P3 | N=500 | Recruiting | Sponsor: Hoffmann-La Roche | Trial primary completion date: Mar 2020 ➔ Apr 2022

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

MR45625: Phase IIIb Study of 36-Week Refill Exchanges of Port Delivery System with Ranibizumab in nAMD (clinicaltrialsregister.eu) - P2/3 | N=164 | Recruiting | Sponsor: F. Hoffmann-La Roche AG

New P2/3 trial • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Antibody-based therapeutics and therapeutic development for diabetic retinopathy: targeting VEGF, Ang/Tie, and inflammatory pathways. (PubMed, Front Endocrinol (Lausanne)) - "Recent clinical innovations include ophthalmic formulations of bevacizumab, high-dose aflibercept, the ranibizumab port delivery system, and bispecific antibodies like faricimab that simultaneously target VEGF and angiopoietin-2 pathways, alongside emerging preclinical investigations into novel targets and bio-engineered delivery platforms. Despite therapeutic advances, significant challenges persist, including cost-effectiveness concerns, treatment burden, and adherence issues. This review highlights the transformative impact of mAb therapy in DR management while acknowledging the need for continued innovation to address existing limitations and optimize patient outcomes through personalized treatment approaches."

Journal • Review • Diabetes • Diabetic Retinopathy • Macular Edema • Metabolic Disorders • Ophthalmology • Retinal Disorders • IL17A • IL1B • IL6

Successful Cataract Surgery in a Patient with a Port Delivery System Implant for Diabetic Macular Edema. (PubMed, Case Rep Ophthalmol) - "The Port Delivery Platform (PDS) with ranibizumab is a novel, surgically implanted device designed for continuous intraocular anti-VEGF delivery, approved for neovascular age-related macular degeneration and other retinal vascular diseases, including diabetic macular edema (DME) and diabetic retinopathy. This case highlights key surgical considerations to preserve implant integrity and conjunctival health during cataract surgery in eyes with PDS implants. To our knowledge, this is the first report of cataract surgery in a PDS-implanted eye outside a clinical trial, emphasizing that standard phacoemulsification techniques can be safely adapted with proper precautions in this context."

Journal • Age-related Macular Degeneration • Cardiovascular • Cataract • Diabetic Macular Edema • Diabetic Retinopathy • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Biologics-device combinations: Enabling prolonged therapies in the posterior segment ocular disease. (PubMed, Adv Drug Deliv Rev) - "This comprehensive review examines the latest advancements of these combination platforms, including refillable implants (e.g., SUSVIMO®), encapsulated cell technology (e.g., ENCELTO™), and recombinant adeno-associated virus (rAAV) vectors (e.g., LUXTURNA®)...However, substantial hurdles, such as instability caused by material-biologics interactions, potential risks during the sterilization and manufacturing processes, safety risks, and the evolving regulatory landscape, still need to be addressed. Achieving a balance between the stability of biologics and advanced device design, enhancing long-term safety, and developing responsive smart systems with real-time monitoring and feedback capabilities remain crucial for the advancement of next-generation ophthalmic therapies."

Journal • Review • Age-related Macular Degeneration • Diabetic Retinopathy • Macular Degeneration • Ophthalmology • Retinal Disorders

VOYAGER: A Real-World Study to Gain Clinical Insights Into Roche Ophthalmology Products (clinicaltrials.gov) - P=N/A | N=6000 | Active, not recruiting | Sponsor: Hoffmann-La Roche | Recruiting ➔ Active, not recruiting | Trial primary completion date: Dec 2026 ➔ Mar 2027

Enrollment closed • Real-world evidence • Trial primary completion date • Age-related Macular Degeneration • Diabetic Macular Edema • Macular Degeneration • Ophthalmology • Retinal Disorders • Retinal Vein Occlusion • Wet Age-related Macular Degeneration

FLORetina 2025: Port delivery system shows reliable 6-month durability and sustained efficacy in neovascular AMD for up to 7 years (Ophthalmology Times) - "The results of the Portal extension trial of the Port Delivery System with ranibizumab (PDS) (Susvimo, Roche/Genentech) for age-related macular degeneration (AMD) showed sustained improvements in vision in 50% of patients out to 7 years after implantation of the device."

P3 data • Age-related Macular Degeneration

PAVILION: A Multicenter, Randomized Study in Participants With Diabetic Retinopathy Without Center-involved Diabetic Macular Edema To Evaluate the Efficacy, Safety, and Pharmacokinetics of Ranibizumab Delivered Via the Port Delivery System Relative to the Comparator Arm (clinicaltrials.gov) - P3 | N=174 | Active, not recruiting | Sponsor: Hoffmann-La Roche | Trial completion date: Jun 2025 ➔ Jan 2026

Trial completion date • Diabetic Macular Edema • Diabetic Retinopathy • Ophthalmology • Retinal Disorders

Organizational Budget Impact Analysis of the Port-Delivery Platform With SUSVIMO in Age-Related Macular Degeneration (AMD) in France (ISPOR-EU 2025) - "The Port Delivery Plateform (PD-P SUSVIMO), an intraocular implant for continuous delivery of ranibizumab 100 mg/mL with a refill every 6 months, demonstrated non-inferiority versus monthly ranibizumab injections in the ARCHWAY study. By reducing the frequency of IVT injections of anti-VEGF, PD-P SUSVIMO could significantly reduce the burden on nAMD patients, leading to substantial savings."

HEOR • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Sightspire: A Study of 36-Week Refill Exchanges of Port Delivery System (PDS) With Ranibizumab in nAMD (clinicaltrials.gov) - P3 | N=250 | 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

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 | Recruiting | Sponsor: Hoffmann-La Roche | Trial completion date: Nov 2026 ➔ Nov 2027 | Trial primary completion date: Nov 2026 ➔ Nov 2027

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

Roche receives CE mark for Contivue, its Port Delivery Platform containing Susvimo, for neovascular age-related macular degeneration (nAMD) (Roche Press Release) - "The device comprises the eye implant through which Susvimo is delivered, and four ancillary devices to initially fill, insert, refill, and remove the implant (if required)."

Commercial • Age-related Macular Degeneration

Susvimo (ranibizumab injection) 100 mg/mL is currently under review with the European Medicines Agency (EMA) for the treatment of nAMD. (Roche Press Release) - "Three clinical studies contribute to the EMA’s evaluation of efficacy and safety of Contivue with Susvimo 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. Data from Archway showed patients treated with Contivue with Susvimo achieved and maintained vision outcomes equivalent to monthly intravitreal (IVT) ranibizumab injections."

EMA filing • 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 2027 ➔ Apr 2028 | Trial primary completion date: Apr 2027 ➔ Mar 2028

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 (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

Roche’s Susvimo maintains vision over five years with two refills per year in people with neovascular age-related macular degeneration (nAMD) (GlobeNewswire) - P3 | N=415 | Archway (NCT03677934) | P3 | N=1,000 | Portal (NCT03683251) | Sponsor: Hoffmann-La Roche | "Roche...announced today new, five-year efficacy, safety and durability data from the Phase III Portal study, a long-term extension of the Phase III Archway study, of Susvimo (ranibizumab injection) for the treatment of people with nAMD. Results show that Susvimo’s immediate and predictable durability was sustained over five years, with approximately 95% of people receiving treatment every six months requiring no supplemental treatment before each refill...Five-year results showed consistent and sustained disease control and retinal drying in a population who entered Archway with vision at or near peak levels after receiving an average of five intravitreal injections per standard of care. In the Susvimo cohort, best-corrected visual acuity (BCVA) was 74.4 letters at baseline and 67.6 letters at 5 years."

P3 data • Age-related Macular Degeneration

A Study of the Efficacy, Safety, and Pharmacokinetics of a 36-Week Refill Regimen for the Port Delivery System With Ranibizumab in Patients With Neovascular Age-Related Macular Degeneration (Velodrome) (clinicaltrials.gov) - P3 | N=451 | Active, not recruiting | Sponsor: Hoffmann-La Roche | Recruiting ➔ Active, not recruiting

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