CHMP issues positive recommendation for EU approval of Roche’s Susvimo

Roche has recently announced that the EMA’s Committee for Medicinal Products for Human Use has issued a positive recommendation for the approval of Susvimo 100 mg/mL for the treatment of neovascular age-related macular degeneration. Susvimo is intended for continuous release into the vitreous via the Contivue implant, with a final European Commission decision expected in the near term.

“The positive CHMP recommendation for Susvimo brings us closer to offering a new treatment option for people in Europe who currently face the burden of frequent eye injections,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “By requiring only two refills per year, Contivue with Susvimo offers a continuous drug delivery approach intended to reduce the frequency of clinic visits, with data from clinical trials supporting maintenance of vision up to seven years.”

In 2025, Roche received a CE mark for its Port Delivery Platform, known in the European Union as Contivue, which encompasses the ocular implant through which Susvimo is administered and four ancillary devices used to initially fill, insert, refill, and remove the implant when necessary. The platform provides uninterrupted delivery of Susvimo directly to the eye.

The recommendation rests on evidence gathered across three clinical investigations in neovascular age-related macular degeneration: the pivotal Phase III Archway study and two supporting investigations, the Phase II LADDER study and the open-label long-term extension Portal study. Archway data demonstrated that patients on Susvimo achieved and sustained vision outcomes equivalent to those seen with monthly intravitreal ranibizumab injections, while longer-term Portal data showed vision maintenance extending up to seven years. With just two refills per year, approximately 95% of Susvimo-treated patients required no additional anti-vascular endothelial growth factor therapy. The treatment was broadly well tolerated across the longer-term observation period.

Contivue has been purpose-built for use with Susvimo. Roche is exploring additional pipeline molecules that may be compatible with the Port Delivery Platform, with the potential to enhance efficacy or durability and ultimately offer patients a wider choice of treatments through Contivue.

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CHMP, Roche, Roche's Susvimo