Roche en route to first continuous delivery treatment for nAMD in Europe

Roche’s European ambitions for its neovascular age-related macular degeneration (nAMD) treatment Susvimo (ranibizumab) have taken a step forward after the firm won a CE mark for its Contivue Port Delivery Platform.

The device contains a customised formulation of Susvimo and comprises of an eye implant, which enables drug delivery, and four ancillary devices to initially fill, insert, refill and remove the implant, if required.

If approved by European regulatory authorities, Susvimo’s combation with Contivue would make it the first continuous delivery treatment for nAMD, a condition that affects around 1.7 million people in the EU.

Dr Levi Garraway, PhD, Roche’s Chief Medical Officer and Head of Global Product Development said: “Susvimo offers people living with nAMD the opportunity to maintain their vision with as few as two treatments per year. Moreover, this sustained delivery brings substantial long-term clinical benefits.”

Addressing unmet need in vision loss

Contivue with Susvimo was approved for nAMD by the US Food and Drug Administration (FDA) in May, adding to its diabetic macular oedema and diabetic retinopathy licences, while the European Medicines Agency (EMA) is currently reviewing it as a treatment for nAMD.

The EMA’s assessment involves three clinical studies: Archway, a pivotal Phase III study, as well as two supportive studies: the Phase II LADDER study and Portal, an open-label long-term extension study.

In the Archway trial, Contivue with Susvimo enabled vision outcomes equivalent to monthly intravitreal (IVT) injections, while new long-term data from the LADDER study found the system provided good visual outcomes with stable retinal anatomy.

For example, over seven years, participants achieved an average decline of only six letters approximately of best-corrected visual acuity (BCVA). This was shown in 59 patients who were at or near peak levels at enrolment following three intravitreal injections of standard of care. Additionally, the durability of Contivue with Susvimo was maintained in approximately 95 percent of patients.

Study investigator Dr Carl Awh, FASR, Tennessee Retina, US concluded: “For patients with nAMD, the sustained drug delivery of Contivue with Susvimo may provide superior visual outcomes compared to the well-demonstrated average decline in vision associated with long-term intravitreal injections.’’