(RTTNews) - Roche Holding AG (RHHBY) said the European Commission has approved Susvimo (ranibizumab 100 mg/mL) for the treatment of neovascular age-related macular degeneration in adults.

Neovascular age-related macular degeneration (nAMD), also known as wet AMD, is an advanced form of macular degeneration that can cause rapid and severe vision loss. It occurs when abnormal blood vessels grow beneath the macula, leading to swelling, bleeding, and fibrosis.

The disease is a leading cause of vision loss in people over 60 and affects approximately 1.7 million people in the European Union (EU).

Susvimo is designed to provide continuous delivery of ranibizumab into the eye through Roche's Contivue refillable implant. This device is surgically inserted during a one-time outpatient procedure.

Ranibizumab is a VEGF inhibitor that targets VEGF-A, a protein involved in abnormal blood-vessel formation and vascular leakage. The treatment can maintain vision with as few as two treatments per year, offering an alternative to frequent intravitreal eye injections.

The EU approval was supported by data from the pivotal Phase 3 Archway study, along with the Phase 2 Ladder study and long-term Portal extension study.

In Archway, Susvimo maintained vision outcomes equivalent to monthly intravitreal ranibizumab injections, while longer-term Portal study showed vision was maintained for up to seven years.

Among patients receiving two refills annually, approximately 95% treated with Susvimo required no supplemental anti-VEGF treatment. The drug candidate was generally well tolerated over the long term.

The approval marks the European authorization of Susvimo as a continuous-delivery treatment option for nAMD, said Roche.

The company previously received a CE mark for the Contivue Port Delivery Platform in the EU in 2025. Contivue with Susvimo is already approved for the treatment of nAMD in Switzerland and Thailand.

RHHBY closed Monday's trade at $55.30, up 2.12% on the OTC Markets.