Susvimo's CHMP Nod Validates Delivery System, But Faces Aflibercept's Simpler Long-Acting Solution

CHMP Recommends EU Approval for Roche's Susvimo

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval for Roche’s Susvimo® (ranibizumab injection) for the treatment of neovascular age-related macular degeneration (nAMD). Susvimo, delivered via the Contivue® refillable implant, offers a continuous treatment alternative to frequent eye injections. This positive recommendation is based on data from the LADDER, Archway (pivotal Phase III), and Portal studies, demonstrating vision maintenance equivalent to monthly intravitreal ranibizumab injections with as few as two treatments per year.

• The CHMP's positive recommendation is supported by robust data from the Archway pivotal Phase III study, along with supportive Phase II LADDER and long-term extension Portal studies. These trials consistently showed that Susvimo maintained vision outcomes equivalent to monthly intravitreal ranibizumab injections, with long-term data from Portal demonstrating vision maintenance for up to seven years.
• Susvimo utilizes the Contivue® refillable implant, a novel Port Delivery Platform, to continuously deliver ranibizumab directly into the eye. This innovative approach significantly reduces the treatment burden for patients, requiring only two refills per year, compared to the frequent standard-of-care injections. Approximately 95% of patients treated with Susvimo in trials did not require supplemental anti-VEGF treatment.
• Neovascular age-related macular degeneration (nAMD) is a leading cause of blindness globally, affecting millions in the EU alone. The potential approval of Susvimo represents a crucial advancement, offering patients a less frequent and more convenient treatment option that can help maintain vision, thereby improving quality of life and potentially reducing the strain on healthcare systems.

Addressing the Burden of Frequent nAMD Injections

While anti-VEGF agents have revolutionized the management of neovascular age-related macular degeneration (nAMD), their long-term effectiveness is constrained by several significant therapeutic challenges. These limitations span issues with treatment efficacy, patient and healthcare system burden, and suboptimal real-world outcomes, driving the need for more durable and effective innovations.

• Limited Therapeutic Efficacy and Suboptimal Response: A significant portion of patients do not respond adequately to anti-VEGF therapy, with vision improvement seen in only 30-40% of individuals. Approximately half of all patients experience an incomplete response to therapy (IRT), and real-world efficacy is often significantly inferior to that reported in randomized controlled trials. Furthermore, current treatments carry a risk of inducing retinal fibrosis and geographic atrophy.

• High Treatment Burden and Poor Adherence: The standard-of-care, involving frequent intravitreal injections and follow-up visits, imposes a substantial burden on patients, caregivers, and healthcare providers. This burden contributes to poor patient compliance and treatment persistence, with real-world data showing that over 50% of patients experience injection delays of more than two weeks, leading to undertreatment and compromising visual outcomes.

• Intensive Healthcare System Demands: As the population ages, the rising demand for eye care strains capacity-constrained healthcare systems, making it difficult to deliver timely treatment. In many regions, this results in significant delays that increase the risk of irreversible vision loss. These systemic challenges highlight the urgent need for more efficient, long-term treatment options to improve patient prognosis and manage the growing socioeconomic burden of nAMD.

Pivotal Data Supporting Susvimo's Efficacy and Safety

Recent clinical investigations into neovascular age-related macular degeneration (nAMD) continue to refine treatment paradigms by evaluating the efficacy, safety, and real-world performance of various anti-VEGF agents. Key studies have assessed newer biologics like faricimab and high-dose aflibercept for their potential to extend dosing intervals, while other research has validated the effectiveness of established therapies and switching strategies. The following table summarizes pivotal outcomes from several recent nAMD studies.

Susvimo's Role in the Evolving nAMD Treatment Landscape

The neovascular age-related macular degeneration (nAMD) treatment landscape has been significantly reshaped by the introduction of new therapies designed to improve durability and reduce patient treatment burden. Recent FDA approvals include brolucizumab, the bispecific antibody faricimab, high-dose aflibercept 8 mg, and a port delivery system for ranibizumab. Real-world data for brolucizumab demonstrates the potential for extended dosing, with last injection intervals at 52 weeks reaching 12.9 weeks in treatment-naïve patients. However, its adoption has been moderated by a relatively high discontinuation rate linked to intraocular inflammation. Faricimab has demonstrated significant improvements in service efficiency, reducing delayed visits by 97.4% and improving loading phase completion by 54.1 percentage points compared to biosimilar aflibercept 2 mg, along with associated cost savings. For difficult-to-treat cases, aflibercept 8 mg has proven effective in extending treatment intervals in refractory nAMD patients while maintaining stable visual and anatomical outcomes.

Concurrent with the arrival of novel agents, treatment paradigms have evolved from reactive pro re nata (PRN) schedules to more structured fixed-interval and treat-and-extend (T&E) regimens. This strategic shift has yielded substantial clinical benefits; a 2025 study comparing a 2019-2021 fixed-interval cohort to a 2009-2010 PRN cohort reported markedly greater improvements in best-corrected visual acuity (+5.5 vs -2.0 ETDRS letters, p<0.001) and central retinal thickness reduction. These superior outcomes were achieved with more injections but fewer monitoring visits and dramatically higher adherence. The landscape is also being influenced by the emergence of biosimilars. For instance, in the phase III NORSE TWO trial, the bevacizumab biosimilar ONS-5010 resulted in a significantly higher proportion of patients gaining ≥15 letters compared to ranibizumab (41.7% vs 23.1%, p=0.0052). However, real-world data indicates that medication transitions can introduce economic complexities, with multiple switches (e.g., from bevacizumab to a biosimilar and then to a branded agent) proving more costly than direct transitions.