Roche’s CE Mark for Contivue: A Game-Changer in Wet AMD Treatment

The recent CE Mark approval for Roche’s Contivue, a groundbreaking port delivery system containing Susvimo, marks a pivotal moment in the treatment of neovascular age-related macular degeneration (nAMD). This innovation, now available in the European Union and other CE-mark-accepting markets, redefines the standard of care for chronic ophthalmic conditions by addressing two critical unmet needs: treatment burden and long-term patient adherence. For investors, Contivue represents not just a technological leap but a strategic asset in a rapidly evolving market.

A Paradigm Shift in Drug Delivery

Contivue’s mechanism of action is a testament to Roche’s commitment to innovation. The device is a refillable implant that delivers Susvimo—a customized formulation of ranibizumab—continuously over months, requiring only two refills per year [1]. This contrasts sharply with the current standard of care, which demands monthly intravitreal injections for nAMD patients. Clinical data from the LADDER study, spanning seven years, underscores the device’s efficacy: patients maintained an average best-corrected visual acuity (BCVA) of 63.2 letters, with only a six-letter decline from baseline [2]. Notably, 95% of patients retained device durability, and half achieved 20/40 vision, a threshold often associated with functional independence [1].

The Archway Phase III trial further validates Contivue’s potential, demonstrating non-inferiority to monthly ranibizumab injections while drastically reducing the need for frequent clinic visits [1]. For a condition that affects 1.7 million people in the EU alone, this shift from a reactive to a proactive treatment model could transform patient outcomes and healthcare economics [1].

Market Dynamics and Competitive Positioning

Roche’s dominance in the wet AMD space is further solidified by its portfolio, which includes Vabysmo (faricimab), a bispecific antibody offering extended dosing intervals of up to 16 weeks [1]. However, Contivue’s unique value proposition lies in its sustained delivery system, which complements Roche’s existing offerings and differentiates it from competitors like Regeneron Pharmaceuticals and Bayer. These firms, while commanding 80–85% of market revenues, remain reliant on traditional anti-VEGF therapies such as aflibercept and ranibizumab, which require frequent administration [1].

The broader ophthalmic drug delivery systems market is projected to grow at a compound annual growth rate (CAGR) of 6.6%, reaching $23.36 billion by 2030 [1]. This growth is driven by rising demand for long-acting formulations and sustained-release technologies, which address the limitations of conventional therapies. Contivue’s entry into this space aligns with a structural shift toward patient-centric care, where reducing treatment frequency is a key differentiator.

Investment Implications and Future Outlook

From an investment perspective, Contivue’s approval in the EU opens new revenue streams for Roche while reinforcing its leadership in chronic disease management. The global ophthalmology drugs market, valued at $43.22 billion in 2024, is expected to grow to $72.59 billion by 2034, fueled by innovations like Contivue and the expanding prevalence of age-related eye diseases [1]. Anti-VEGF therapies, which dominate the market, are particularly well-positioned to benefit from advancements in delivery systems, as they address conditions like diabetic macular edema (DME) and myopic macular degeneration [3].

Moreover, Contivue’s success in nAMD could catalyze expansion into other indications, such as DME and diabetic retinopathy, where Roche already has a strong presence. The device’s potential to reduce healthcare costs—by minimizing hospital visits and complications from missed treatments—further enhances its appeal to payers and providers.

Conclusion

Roche’s Contivue is more than a product; it is a strategic investment in the future of ophthalmic care. By leveraging cutting-edge drug delivery technology, Roche addresses the limitations of existing therapies while capturing a growing market. For investors, the CE Mark approval signals a maturation of the company’s innovation pipeline and a commitment to redefining treatment paradigms. As the global burden of chronic eye diseases rises, Contivue’s ability to deliver sustained efficacy with minimal patient burden positions Roche as a leader in a market poised for transformative growth.

Source:
[1] Roche receives CE mark for Contivue, its Port Delivery Platform containing Susvimo, [https://www.roche.com/media/releases/med-cor-2025-09-04]
[2] Global Ophthalmic Drug Delivery Systems Market Size Report, 2030, [https://www.grandviewresearch.com/industry-analysis/ophthalmic-drug-delivery-systems-market-report]
[3] Myopic Macular Degeneration Market Analysis, [https://www.optometrytimes.com/view/myopic-macular-degeneration-market-analysis-estimates-significant-growth-in-the-next-decade]