Jul 29, 2026 · 12 min · 6 segments
The CEO of Outlook Therapeutics discusses the FDA approval of wet AMD drug Lytenava; Roche receives a major boost in its efforts to commercialize wet AMD treatment Susvimo in Europe; and Glaukos…
Bob JarrGuest
Briana ClarkHost
Stephen Daly
The European Medicines Agency's Committee for Medicinal Products for Human Use issued a positive opinion recommending approval of Roche's SUSVIMO for wet AMD.
The CHMP recommendation covers the use of SUSVIMO for the Contaviu implant, a refillable ocular implant designed to provide continuous delivery of ranabizumab into the vitreous.
Roche said a final regulatory decision is expected from the European Commission in the coming months.
The recommendation is supported by data from three clinical studies, the Phase III Archway Trial, the Phase II Ladder Study, and the Open Label Long-Term Extension Study Portal.
Results from the Archway Trial demonstrated that patients receiving sesvimo achieved visual outcomes equivalent to those receiving monthly intravitreal ranibizumab injections.
Across the studies, approximately 95% of patients treated with sesvimo required no supplemental anti-VEGF therapy while receiving scheduled refills twice annually.
Long-term findings from the portal extension study showed maintenance of visual outcomes for up to seven years.
The CHMP recommendation follows Roche's 2025 CE mark for the port delivery platform, marketed in the European Union as Contivio.
The European Medicines Agency's Committee for Medicinal Products for Human Use issued a positive opinion recommending approval of Roche's SUSVIMO for wet AMD.
The CHMP recommendation covers the use of SUSVIMO for the Contaviu implant, a refillable ocular implant designed to provide continuous delivery of ranabizumab into the vitreous.
Roche said a final regulatory decision is expected from the European Commission in the coming months.
The recommendation is supported by data from three clinical studies, the Phase III Archway Trial, the Phase II Ladder Study, and the Open Label Long-Term Extension Study Portal.
Results from the Archway Trial demonstrated that patients receiving sesvimo achieved visual outcomes equivalent to those receiving monthly intravitreal ranibizumab injections.
Across the studies, approximately 95% of patients treated with sesvimo required no supplemental anti-VEGF therapy while receiving scheduled refills twice annually.
Long-term findings from the portal extension study showed maintenance of visual outcomes for up to seven years.
The CHMP recommendation follows Roche's 2025 CE mark for the port delivery platform, marketed in the European Union as Contivio.
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