Susvimo EC Approval: Delivery Innovation Clears Regulatory Bar, But HTA Reimbursement Case Remains Unproven

European Commission Approves Roche's Susvimo for nAMD

The European Commission has approved Roche's Susvimo (ranibizumab 100 mg/mL solution for injection) for the treatment of neovascular age-related macular degeneration (nAMD). This approval introduces a continuous delivery option via the Contivue refillable implant, offering a significant alternative to frequent standard-of-care eye injections. Clinical data from the pivotal Phase III Archway study demonstrated that Susvimo maintained vision equivalent to monthly intravitreal ranibizumab injections, with long-term follow-up in the Portal study showing vision maintenance for up to seven years. This innovative treatment aims to reduce patient burden by requiring as few as two treatments per year.

• Novel Continuous Delivery System: Susvimo is the first and only continuous delivery treatment for nAMD, utilizing the Contivue refillable implant. This system is surgically inserted and continuously delivers a customized formulation of ranibizumab directly into the eye, providing a sustained therapeutic effect and significantly reducing the need for frequent clinic visits and injections.
• Demonstrated Efficacy and Durability: The approval is primarily supported by the Phase III Archway study, which showed Susvimo achieved and maintained vision outcomes equivalent to monthly intravitreal ranibizumab injections. Further long-term data from the Portal study indicated that vision was maintained for up to seven years, with approximately 95% of patients requiring no supplemental anti-VEGF treatment with only two refills per year.
• Addressing Patient Burden and Unmet Needs: Neovascular AMD is a leading cause of vision loss affecting millions globally, with many patients discontinuing treatment due to the burden of frequent injections. Susvimo offers a unique solution by providing sustained efficacy with a dramatically reduced treatment frequency (as few as two treatments annually), thereby improving patient adherence and quality of life while maintaining visual acuity.

Addressing the Burden of Frequent Injections in nAMD

Anti-VEGF therapy has transformed the management of neovascular AMD, maintaining visual acuity in more than 90% of patients in large-scale clinical trials. Yet real-world outcomes consistently fall short of trial benchmarks, driven by a convergence of clinical, biological, and logistical challenges.

• Undertreatment and injection burden. In the RADIANCE study, patients received a median of only 5.0 injections in the first year, with injection frequency declining over time — a pattern associated with suboptimal visual outcomes. Patients receiving ≥ 6 injections showed better visual acuity results, underscoring that undertreatment is a primary driver of real-world efficacy gaps. The labor-intensive nature of intravitreal therapy and its cost compound this burden for both patients and healthcare systems.

• Variable and unpredictable treatment response. Response to anti-VEGF therapy depends on patient age, lesion characteristics, lesion duration, baseline visual acuity, and the presence of particular genotype risk alleles. Primary and secondary responses are dissociated — secondary responses cannot be predicted from the primary phase — and morphological and functional responses do not necessarily correlate in an individual eye. A ceiling effect further limits the utility of standard functional metrics (e.g., >5-letter improvement) when baseline visual acuity is good (ETDRS >70 letters).

• Acquired resistance and persistent exudation. Despite standardized therapy, persistent fluid or recurrent exudation occurs in a number of patients. Acquired resistance may arise through activation of alternative angiogenic signaling pathways that bypass VEGF blockade, as well as through metabolic reprogramming of ocular endothelial glycolysis that impairs blood-retinal barrier function and counteracts the clinical efficacy of VEGF-targeted treatment.

• Progressive structural damage under long-term therapy. Atrophic changes — including geographic atrophy, fibrosis, and RPE porosity — increase significantly during long-term anti-VEGF follow-up. In one study, fibrosis prevalence rose from 28% to 89% (p = 0.0001) and geographic atrophy from 0% to 67% (p = 0.0002) over a mean follow-up of 84 months. The progression of macular atrophy appears faster under ranibizumab than bevacizumab and on a monthly rather than as-needed dosing basis, and the contribution of therapy itself cannot be fully separated from the spontaneous progression of AMD.

• Patient compliance barriers. Non-clinical factors — including transportation difficulties (reported by 55.3% of patients in one study), financial burden from appointments (30.7%), and fear of injection (66%) — contribute meaningfully to missed treatments and suboptimal outcomes. Younger patients and those with shorter diabetes duration demonstrated significantly higher compliance rates, highlighting the heterogeneity of adherence across patient populations.

• Absence of consensus definitions for treatment failure. There is currently no consensus on how to classify optimal response, poor response, or non-response, nor on the definitions of refractory versus recurrent neovascular AMD. This lack of standardization complicates clinical decision-making around drug switching, combination therapy, and treatment discontinuation.

Archway and Portal: Sustained Vision with Fewer Treatments

Recent clinical investigations into neovascular AMD have evaluated a range of anti-VEGF agents and adjunctive therapies, highlighting meaningful gains in visual acuity and anatomical outcomes alongside distinct safety profiles. The studies below span treatment-naïve populations, treatment-resistant cohorts, and adjunctive surgical approaches, offering a broad view of the current evidence landscape.

Reshaping the nAMD Treatment Landscape with Continuous Delivery

The treatment landscape for neovascular AMD (nAMD) has shifted markedly toward agents that combine robust anatomical outcomes with reduced injection burden. A 2025 network meta-analysis of 49 randomised clinical trials encompassing 23,257 eyes found that while no anti-VEGF drug or regimen delivered superior best-corrected visual acuity (BCVA) gains over monthly ranibizumab, several newer agents achieved statistically significant reductions in central retinal thickness (CRT). Brolucizumab 6 mg (loading dose then every 8–12 weeks) produced a CRT reduction of -38.1 µm over the reference, while aflibercept 8 mg dosed at loading then every 16 weeks achieved -32.1 µm, and faricimab 6 mg in a treat-and-extend regimen achieved -18.1 µm. The same analysis concluded that faricimab 6.0 mg or aflibercept 8.0 mg — in regimens combining a loading phase with either treat-and-extend or fixed 12- to 16-week intervals — provided the optimal balance between visual outcomes, anatomical outcomes, and lowest treatment burden, though the authors noted that long-term efficacy data for these newer agents remain warranted.

The emergence of faricimab, which targets both VEGF and angiopoietin-2, has introduced a new mechanistic dimension to nAMD management. A 2026 retrospective study comparing three monthly loading injections of aflibercept 8 mg versus faricimab in treatment-naïve patients found that both agents produced significant and comparable improvements: BCVA improved from 0.59 to 0.39 logMAR with aflibercept 8 mg and from 0.62 to 0.45 logMAR with faricimab, with no statistically significant between-group difference in BCVA improvement (P=0.685) or CRT reduction (P=0.320). Complete retinal fluid resolution was achieved in 80.4% and 87.8% of patients, respectively (P=0.234). Real-world data from the TRUCKEE study further explored switching dynamics: among 134 eyes transitioned from brolucizumab to faricimab, a statistically significant CST reduction of -5.25 µm was observed after one faricimab injection (P=0.048), with numerical — though not statistically significant — improvements in BCVA (+1.63 letters, P=0.174) and retreatment interval (+5.0 days, P=0.769) after three injections, suggesting a potential additive role for angiopoietin-2 suppression even in eyes already on maximal VEGF blockade.

Brolucizumab's integration into clinical practice has been accompanied by a more nuanced understanding of its safety profile. The HAWK and HARRIER trials established rates of 4.6% for definite or probable intraocular inflammation (IOI), 3.3% for retinal vasculitis, and 2.1% for retinal vascular occlusion, prompting Novartis to convene an external safety review committee and develop a formal risk mitigation framework. Subsequent real-world and retrospective studies have refined the characterisation of IOI risk: a 2023 study identified a prior anti-VEGF injection count greater than 14 (OR: 1.12, P=0.006) and a laser flare-cell photometry value exceeding 15 photon count per millisecond (OR: 81.6, P=0.031) as independent predictors of IOI following brolucizumab. Despite these safety considerations, switch studies — including a Japanese retrospective cohort and the European SHIFT study — demonstrated meaningful anatomical benefits, with the Japanese cohort reporting significant reductions in central foveal thickness (P<0.05) and central choroidal thickness (P<0.001), and a treatment interval extension from 5.75 to 8.12 weeks following the switch from aflibercept. Health-economic modelling in the Netherlands further contextualised these developments, projecting aflibercept 8 mg as the lowest-cost option at €16,251 per patient over three years, underscoring that durability gains translate into tangible system-level savings.

Susvimo's Approval: A New Paradigm for Sustained nAMD Treatment

The European Commission's approval of Roche's Susvimo for neovascular age-related macular degeneration (nAMD) marks a pivotal moment in the management of this leading cause of blindness. For years, the standard of care has relied on frequent intravitreal anti-VEGF injections, a regimen that, while effective, places a significant burden on patients and healthcare systems. This often leads to suboptimal adherence and, consequently, less than ideal visual outcomes in the real world.

Susvimo, with its Port Delivery System (PDS), offers a paradigm shift by providing continuous ranibizumab delivery via a refillable implant, reducing treatment frequency to as few as two times per year. Clinical trials have demonstrated that this approach maintains vision equivalent to monthly injections, with long-term data supporting its sustained efficacy. This innovation directly addresses the unmet need for durable therapy, potentially enhancing patient adherence and improving overall quality of life.

However, the introduction of a surgically implanted device brings its own set of considerations. While studies indicate that the types and rates of post-surgical complications are comparable to other ocular implants that cross the sclera, the need for a precise surgical procedure for insertion and refills requires specialized training for ophthalmologists. Furthermore, the cost-effectiveness of Susvimo will be a critical factor in its market adoption. While it offers long-term cost savings compared to frequent ranibizumab or aflibercept injections under certain scenarios, it remains more expensive than off-label bevacizumab and could face challenges if real-world refill intervals are shorter than anticipated. The nAMD landscape is also increasingly competitive, with other long-acting agents and novel mechanisms emerging that offer extended dosing without surgical intervention. Susvimo's success will hinge on its ability to demonstrate a compelling balance of clinical benefit, patient convenience, and economic value within this evolving market.