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

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

FDA Approves Genentech’s Susvimo for Diabetic Retinopathy (Genentech Press Release) - "Genentech...announced today that the U.S. Food and Drug Administration (FDA) has approved Susvimo (ranibizumab injection) 100 mg/mL for the treatment of diabetic retinopathy (DR), a potentially blinding condition that affects almost 10 million people in the U.S. and more than 100 million people globally. It is the first and only FDA-approved continuous delivery treatment shown to maintain vision in people with DR with just one refill every nine months. Susvimo is now available to U.S. retina specialists and their patients with DR who have previously responded to at least two anti-vascular endothelial growth factor (VEGF) injections...The FDA decision was based on positive one-year results from the Phase III Pavilion study."

FDA approval • Diabetic Retinopathy

Beyond the injection: delivery systems reshaping retinal disease management. (PubMed, Expert Opin Pharmacother) - "Specific innovations discussed include the ranibizumab port delivery system, EYP-1901 (Duravyu, vorolanib implant), KSI-301 (tarcocimab tedromer), KSI-501, OTX-TKI (Axpaxli, axitinib implant), 4D-150, revakinagene taroretcel-lwey (Encelto, NT-501, encapsulated cell therapy), Xipere (triamcinolone acetonide injectable suspension), AU-011 (belzupacap sarotalocan targeted delivery), ABBV-RGX-314, elamipretide, and OCS-01 (high concentration dexamethasone)...Challenges include overcoming the blood-retinal barrier, surgical complications with implantable devices, and ensuring patient adherence. Advances in smart delivery systems, drug formulations, and predictive models, alongside interdisciplinary collaboration, will be crucial in achieving personalized, effective, and sustainable retinal therapies."

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

Structural Updates to the Implant and Refill Needle of the Port Delivery Platform. (PubMed, Transl Vis Sci Technol) - "The purpose of this study was to report the impact of component-level changes and manufacturing process improvements on septum durability in the ocular implant of the Port Delivery Platform (PD-P), more commonly known as the Port Delivery System with ranibizumab (PDS) with its current formulation...Structural updates to the PD-P implant and refill needle have met and exceeded performance specifications, mitigating the risk of future septum dislodgement in the updated product. Structural updates to the PD-P implant and refill needle resulted in the ability to withstand the equivalent of over 50 years of simulated use without septum dislodgement and should improve the longevity of the device in clinical use."

Journal

Volumetric analysis of retinal fluids in Archway phase 3 trial of the Port Delivery System with ranibizumab (PDS) in patients with nAMD (ARVO 2025) - P3 | "Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand. Describe the big picture and the implications of your findings, not the study itself and the associated details."

Clinical • P3 data • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Strategies for Minimizing Early and Late Complications of the Port Delivery System (ARVO 2025) - "Describe the big picture and the implications of your findings, not the study itself and the associated details. Frequent intraocular injections in diabetes and wet macular degeneration eyes can be reduced to twice yearly with a newly designed implant which delivers Lucentis over extended period of time."

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

Real-World Efficacy and Safety of the Ranibizumab Port-Delivery System in Neovascular AMD: First Time Two-Year Results of the SUMMIT Study (ARVO 2025) - "Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand. Describe the big picture and the implications of your findings, not the study itself and the associated details."

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

Pigment Epithelial Detachment Thickness Fluctuations in the Archway Trial of the Port Delivery System With Ranibizumab (ARVO 2025) - P3 | "Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand. Describe the big picture and the implications of your findings, not the study itself and the associated details."

Age-related Macular Degeneration • Diabetic Retinopathy • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Retinal fluid and thickness fluctuations in patients with diabetic macular edema: results from the Pagoda trial of Port Delivery System with Ranibizumab (PDS) (ARVO 2025) - P3 | "In results from the first 2 years of the study, the PDS helped to control fluid buildup in the eye and changes to the thickness of the retina as effectively as monthly ranibizumab injections, with similar improvements in vision. These results suggest that the PDS could benefit patients without the need for monthly eye injections."

Clinical • Diabetic Macular Edema • Ophthalmology

Sustained suppression of aqueous humor free vascular endothelial growth factor following continuous delivery via the Port Delivery System with ranibizumab in the Pagoda and Pavilion trials (ARVO 2025) - P3 | "Researchers collected eye fluid samples at different times to test VEGF levels in treated eyes. The VEGF levels in the eyes with the PDS remained low throughout treatment with PDS, including up to 9 months after refill, and were similar to levels in eyes treated with monthly eye injections."

Diabetic Macular Edema • Diabetic Retinopathy • Ophthalmology • Retinal Disorders • VEGFA

Impact of Port Delivery System with ranibizumab (PDS) treatment in study eyes vs anti-VEGF injections in fellow eyes on efficacy and safety outcomes in patients with bilateral diabetic macular edema (DME) in the Pagoda trial (ARVO 2025) - P3 | "However, the PDS eyes showed better control of disease activity, including the prevention of disease worsening. Side effects affecting the eye were similar in both the eyes treated with the PDS and those receiving anti-VEGF injections."

Clinical • Diabetic Macular Edema • Diabetic Retinopathy • Ocular Infections • Ocular Inflammation • Ophthalmology • Retinal Disorders

Port Delivery System With Ranibizumab vs Monitoring in Nonproliferative Diabetic Retinopathy Without Macular Edema: The Pavilion Randomized Clinical Trial. (PubMed, JAMA Ophthalmol) - P3 | "These findings should be balanced with the transient, postoperative decrease in BCVA 4 through 12 weeks after implantation and the need for longer-term BCVA and safety outcomes. ClinicalTrials.gov Identifier: NCT04503551."

Clinical • Journal • Cataract • Diabetes • Diabetic Macular Edema • Diabetic Retinopathy • Hematological Disorders • Macular Edema • Metabolic Disorders • Ocular Infections • Ocular Inflammation • Ophthalmology • Retinal Disorders

Continuous Ranibizumab via Port Delivery System vs Monthly Ranibizumab for Treatment of Diabetic Macular Edema: The Pagoda Randomized Clinical Trial. (PubMed, JAMA Ophthalmol) - P3 | "Continuous ranibizumab, 100 mg/mL, via PDS was approved in the US for patients with DME in February 2025 and provides effective, durable, and generally well-tolerated treatment for DME with retreatment every 6 months through at least 64 weeks. ClinicalTrials.gov Identifier: NCT04108156."

Clinical • Journal • Diabetic Macular Edema • Ocular Infections • Ocular Inflammation • Ophthalmology • Retinal Disorders

Macular Atrophy-Related Observations in Eyes Treated with the Port Delivery System with Ranibizumab in the Archway Trial. (PubMed, Ophthalmol Retina) - "In the Archway trial, which compared PDS Q24W with monthly ranibizumab injections for nAMD treatment over 2 years, prevalence and incidence of MA were similar between arms over the study duration. In eyes without baseline MA, PDS-treated eyes had less MA area by 3.4 mm2, a potentially clinically meaningful (although not statistically significant) difference. The results of this prespecified exploratory analysis suggest that PDS treatment is not associated with higher incidence or progression of MA when compared with monthly injections of ranibizumab. In eyes without baseline MA, the progression of atrophy area was 4 times less in PDS-treated eyes. Additional studies could further elucidate this observation."

Journal • 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 | Not yet recruiting | Sponsor: Hoffmann-La Roche

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