Roche has received the CE mark for Contivue, its port delivery platform for administering Susvimo (ranibizumab) to treat neovascular age-related macular degeneration (nAMD).
Contivue is a surgically implanted, refillable eye implant that aims to consistently deliver a customised formulation of ranibizumab over time.
It involves a one-time outpatient procedure and includes four ancillary devices for filling, inserting, refilling, and removing the implant.
Contivue is approved in the US for nAMD, diabetic macular oedema, and diabetic retinopathy. Roche aims to expand the platform with more molecules in its pipeline.
Its continuous delivery method represents a significant advancement in treatments, reducing the frequency of injections required for these conditions, said the company.
Roche chief medical officer and global product development head Levi Garraway 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, as demonstrated by the seven years of follow-up data from the LADDER study.”
The European Medicines Agency (EMA)’s review of Contivue’s efficacy and safety for nAMD includes data from the Phase 3 Archway study and two supportive studies.
The supportive studies include the Phase 2 LADDER study and an open-label long-term extension study, dubbed Portal.
In the Archway study, patients receiving Contivue with Susvimo achieved and maintained vision outcomes equivalent to monthly intravitreal ranibizumab injections.
New data from the seven-year LADDER study indicate that Contivue with Susvimo achieves favourable visual outcomes and maintains stable retinal anatomy over time.
The study showed that vision outcomes were comparable to monthly intravitreal ranibizumab injections, with durability sustained in around 95% of patients.
LADDER study investigator Carl Awh said: “The seven-year results from the LADDER study powerfully demonstrate the long-term outcomes delivered by Contivue with Susvimo.
“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.’’
Recently, Roche signed a licensing agreement with Foresight Diagnostics covering the latter’s PhasED-Seq technology for non-Hodgkin’s lymphoma (NHL).
