- Susvimo, previously called Port Delivery System with ranibizumab, is the first nAMD treatment in 15 years to provide an alternative to standard-of-care eye injections needed as often as once a month
- By continuously delivering medicine into the eye through a refillable implant, Susvimo may help people with nAMD maintain their vision with as few as two treatments per year
- Neovascular AMD impacts approximately 20 million people worldwide and is a leading cause of blindness in people over the age of 60
“Susvimo represents a major advancement in the treatment of retinal disease and is an important new option for patients with wet AMD,” said
Susvimo delivers ranibizumab continuously, offering people living with nAMD an alternative to anti-VEGF eye injections needed as often as once a month.3,4,5 The implant is surgically inserted into the eye during a one-time, outpatient procedure and refilled every six months.5,6 If necessary, supplemental ranibizumab treatment can be given to the affected eye while the Susvimo implant is in place.5
“We believe that Susvimo can help people with nAMD preserve their vision while potentially alleviating the treatment burden associated with current standards of care,” said
The approval is based on positive results from the phase III Archway study primary analysis, which showed nAMD patients treated with Susvimo achieved and maintained vision gains equivalent to monthly ranibizumab injections – +0.2 and +0.5 eye chart letters from baseline, respectively – at weeks 36 and 40 of treatment. In addition, only 1.6% of Susvimo patients received supplemental ranibizumab treatment before their first refill, and more than 98% could go six months before their first refill.5
In the Archway study, Susvimo was generally well-tolerated, with a favourable benefit-risk profile. However, the Susvimo implant has been associated with a three-fold higher rate of endophthalmitis than monthly intravitreal injections of ranibizumab. Many of these events were associated with conjunctival retractions or erosions. Appropriate conjunctiva management and early detection with surgical repair of conjunctival retractions or erosions may reduce the risk of endophthalmitis. In clinical trials, 2.0% of patients receiving a ranibizumab implant experienced at least one episode of endophthalmitis. The most common adverse events (AEs) were conjunctival haemorrhage, conjunctival hyperaemia, iritis and eye pain.6 The safety profile of Susvimo in the clinical trial setting is well understood and will continue to be monitored closely.5
Susvimo will be available in
Roche’s late-stage ophthalmology portfolio also includes faricimab, a bispecific antibody under FDA and EMA review for the treatment of nAMD and DME. The FDA is additionally reviewing faricimab for the treatment of diabetic retinopathy.
About the Archway Study5,11,12
Archway (NCT03677934) was a randomised, multicentre, open-label phase III study evaluating the efficacy and safety of Susvimo™ (ranibizumab injection) 100 mg/mL for intravitreal use via ocular implant administered via the Susvimo eye implant, refilled every six months at fixed intervals, compared to monthly intravitreal injections of ranibizumab 0.5 mg in 415 people living with neovascular or “wet” age-related macular degeneration (nAMD). Patients enrolled in Archway were responders to prior treatment with anti-vascular endothelial growth factor (VEGF) therapy. In both study arms, patients were treated with at least three anti-VEGF injections within the six months prior to their Archway screening visit. The primary endpoint of the study was the change in best-corrected visual acuity (BCVA) score (the best distance vision a person can achieve – including with correction such as glasses – when reading letters on an eye chart) from baseline at the average of Week 36 and Week 40. Secondary endpoints include safety, overall change in vision (BCVA) from baseline and change from baseline in centre point thickness over time.
According to pre-specified study criteria, Susvimo was shown to be non-inferior and equivalent to monthly ranibizumab injections. On average, patients had received five prior ranibizumab injections before their first study treatment visit. In the Susvimo arm of the study, patients gained an average of 0.2 eye chart letters in visual acuity from baseline compared with 0.5 eye chart letters for the monthly ranibizumab arm. During the first treatment interval, before the first scheduled refill, 1.6% of Susvimo patients assessed (n=4/246) received supplemental ranibizumab treatment, and 98.4% of patients (n=242/246) did not receive supplemental treatment.
In the Archway study, Susvimo was generally well-tolerated, with a favourable benefit-risk profile. The safety profile of Susvimo in the clinical trial setting is well understood and will continue to be monitored closely.
About neovascular age-related macular degeneration
Age-related macular degeneration (AMD) is a condition that affects the part of the eye that provides sharp, central vision needed for activities like reading.13 Neovascular or “wet” AMD (nAMD) is an advanced form of the disease that can cause rapid and severe vision loss.1,2 It develops when new and abnormal blood vessels grow uncontrolled under the macula, causing swelling, bleeding and/or fibrosis.2 Worldwide, around 20 million people are living with nAMD – the leading cause of vision loss in people over the age of 60 – and the condition will affect even more people around the world as the global population ages.13, 14, 15
About Susvimo (ranibizumab injection) 100 mg/mL for intravitreal use via ocular implant
Susvimo™ (ranibizumab injection) 100 mg/mL for intravitreal use via ocular implant is a refillable eye implant surgically inserted into the eye during a one-time, outpatient procedure. Susvimo continuously delivers a customised formulation of ranibizumab over time.5 Susvimo is indicated for intravitreal use via the Susvimo eye implant only.6 Ranibizumab is a vascular endothelial growth factor (VEGF) inhibitor designed to bind to and inhibit VEGF-A, a protein that has been shown to play a critical role in the formation of new blood vessels and the leakiness of the vessels.4
Susvimo is different from the ranibizumab intravitreal injection, a medicine marketed as Lucentis®* (ranibizumab injection), which is approved to treat neovascular or “wet” age-related macular degeneration (nAMD) and other retinal diseases. Lucentis®️* was first approved for nAMD by the FDA in 2006.16
About
We have the broadest retina pipeline in Ophthalmology, covering early- and late-stage products, which is led by science and informed by insights from people with eye diseases. Our late-stage pipeline includes faricimab, a potential first-of-a-kind treatment being evaluated in a number of retinal conditions including neovascular age-related macular degeneration (nAMD), diabetic macular edema and diabetic retinopathy. Faricimab is the first investigational bispecific antibody designed for the eye.17 It targets two distinct pathways – via angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A) – that drive a number of retinal conditions, to stabilise blood vessels, potentially improving vision outcomes for longer.4,17 Our early-stage pipeline includes gene therapies and treatments for geographic atrophy and other vision-threatening diseases, including rare and inherited conditions.
Applying our extensive experience, we have already brought breakthrough ophthalmic treatments to people living with vision loss through Lucentis®️* (ranibizumab injection), the first treatment approved to improve
vision in people with certain retinal conditions, and SusvimoTM (ranibizumab injection) 100 mg/mL for intravitreal use via ocular implant, the first FDA-approved refillable eye implant for nAMD that continuously delivers a customised formulation of ranibizumab over a period of months.
About
Founded in 1896,
The
*Lucentis® (ranibizumab injection) was developed by
All trademarks used or mentioned in this release are protected by law.
References
[1] Pennington KL, DeAngelis MM. Epidemiology of age-related macular degeneration (AMD): associations with cardiovascular disease phenotypes and lipid factors. Eye and Vision. 2016;3:34.
[2] Little K, et al. Myofibroblasts in macular fibrosis secondary to neovascular age-related macular degeneration-the potential sources and molecular cues for their recruitment and activation. EBioMedicine. 2018;38:283-91.
[3] Schmidt-Erfurth U, et al. Intravitreal aflibercept injection for neovascular age-related macular degeneration: ninety-six-week results of the VIEW studies. Ophthalmology. 2014;121:193-201.
[4] Heier JS, et al. The Angiopoietin/Tie pathway in retinal vascular diseases: a review. Retina-J Ret
[5] Holekamp N, Campochiaro P, et al. Archway Randomized Phase 3 Trial of the Port Delivery System With Ranibizumab for Neovascular Age-Related Macular Degeneration. Ophthalmology. 2021.
[6] FDA. Highlights of prescribing information, Susvimo. 2021
[7] ClinicalTrials.gov. Extension study for the port delivery system with ranibizumab (Portal) [Internet; cited
[8] ClinicalTrials.gov. This study will evaluate the efficacy, safety, and pharmacokinetics of the port delivery system with ranibizumab in participants with diabetic macular edema compared with intravitreal ranibizumab (Pagoda) [Internet; cited
[9] ClinicalTrials.gov. 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 (PAVILION) [Internet; cited
[10] ClinicalTrials.gov. 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) [Internet; cited
[11] ClinicalTrials.gov. A phase III study to evaluate the Port Delivery System with ranibizumab compared with monthly ranibizumab injections in participants with wet age-related macular degeneration (ARCHWAY) [Internet; cited
[12] Regillo C, et al. Port delivery system with ranibizumab (PDS) for nAMD: Updated data from the Archway phase 3 trial. Angiogenesis, Exudation, and Degeneration 2021 Annual Meeting; 2021 February 12–13.
[13]
[14] Wong WL ,et al. Global prevalence of age-related macular degeneration and disease burden projection for 2020 and 2040: a systematic review and meta-analysis.
[15] Connolly E, et al. Prevalence of age-related macular degeneration associated genetic risk factors and 4-year progression data in the Irish population. Br
[16] FDA. Highlights of prescribing information, Lucentis. 2012 [Internet; cited
[17] Khan M, et al. Targeting Angiopoietin in retinal vascular diseases: A literature review and summary of clinical trials involving faricimab. Cells. 2020;9:1869.
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