Roche Susvimo Wins CHMP OK for Wet AMD Continuous Delivery

Roche (RHHBY) announced on July 24, 2026 that the EMA’s Committee for Medicinal Products for Human Use recommended approval of Susvimo (ranibizumab injection) 100 mg/mL for neovascular age-related macular degeneration in the EU. The European Commission typically follows CHMP opinions within 67 days.

RHHBY closed at $54.70 on July 24, up modestly on the announcement.

What Susvimo is

This is not a new molecule. Ranibizumab is the active ingredient in Lucentis, an anti-VEGF antibody that has treated wet AMD since 2006. The innovation is the Port Delivery System, a refillable implant surgically placed in the eye wall that continuously releases the drug. Patients need refills only twice a year instead of the monthly or bimonthly injections that standard anti-VEGF therapy requires.

The CHMP opinion is based on three studies: the Phase 3 Archway trial, the Phase 2 LADDER study, and the open-label Portal extension. Archway showed Susvimo achieved and maintained vision equivalent to monthly intravitreal ranibizumab injections. Portal data showed vision maintenance up to seven years. Approximately 95% of Susvimo patients required no supplemental anti-VEGF treatment.

Why dosing burden matters

Wet AMD is a leading cause of vision loss in older adults, driven by abnormal blood vessel growth under the retina. Roughly 20 million Americans have some form of AMD, with the wet subtype accounting for about 10% of cases. Standard treatment means an eye injection every four to eight weeks, indefinitely. That burden leads to real-world undertreatment: patients skip visits, disease progresses, vision is lost. A device that cuts clinic visits to two per year directly addresses the problem.

Roche competes against Regeneron’s Eylea franchise and Vabysmo (faricimab) in ophthalmology. Both are under pricing and biosimilar pressure. Susvimo’s dosing convenience is the differentiator, not the drug itself.

US context and the recall

The FDA approved Susvimo for nAMD in October 2021, then pulled it from the market in 2022 after device leaks were reported. Roche reintroduced the product in July 2024 with a redesigned implant. The CHMP opinion validates the safety profile of the updated device and could support US adoption, where Roche also holds approvals for diabetic macular edema and diabetic retinopathy with Susvimo.

What to watch

The European Commission decision is the next step. In the US, watch Susvimo’s uptake trajectory against Eylea biosimilars and Vabysmo. The refillable implant requires surgical insertion, which is a adoption barrier Eylea and Vabysmo do not face. For more on how regulatory decisions move biotech stocks, see our guide to PDUFA dates.