The suppliers of two new anti-VEGF therapies recently cleared in the US that work to reduce macular disease treatment burdens are seeking approval to list the treatments on the Australian Pharmaceutical Benefits Scheme (PBS).
One of the therapies – a port delivery system with ranibizumab to treat neovascular age-related macular degeneration (nAMD) called Susvimo – is also seeking a new Medicare item number with the Medicare Services Advisory Committee (MSAC).
If approved, the therapies would significantly expand the number of available and PBS-listed anti-VEGF treatments in Australia, which currently include Eylea (aflibercept) Lucentis (ranibizumab) and, more recently, Beovu (brolucizumab).
In October 2021, the US Food and Drug Administration (FDA) cleared Genentech’s Susvimo therapy for nAMD in patients who have previously responded to at least two anti-VEGF injections. The implant has been described as the first and only FDA-approved treatment for nAMD offering as few as two treatments per year.
Then, in January 2022, the US regulator approved Vabysmo (faricimab-svoa) for nAMD and diabetic macular edema (DME). It is said to be the first and only FDA-approved injectable eye medicine for nAMD and DME that improves and maintains vision with treatments from one to four months apart in the first year following four initial monthly doses.
Both therapies are now being considered by the Pharmaceutical Benefits Advisory Committee (PBAC) in Australia.
At PBAC’s March 2022 meeting, drug company Roche sought PBS listing of Susvimo for nAMD for patients who are responsive to prior anti-VEGF treatment. The outcome is yet to be published.
The therapy is also before MSAC for a new Medicare item number, which also hasn’t been decided.
Vabysmo’s supplier is seeking PBS listing for DMO at PBAC’s meeting this month.
Clinical data
Genentech said Susvimo was shown to be non-inferior and equivalent to monthly ranibizumab injections
The therapy’s FDA approval was based on positive results from the Phase 3 Archway study, which showed nAMD patients treated with Susvimo achieved and maintained vision gains equivalent to monthly ranibizumab injections at weeks 36 and 40 of treatment.
In addition, only 1.6% of Susvimo patients received supplemental ranibizumab treatment before their first refill, and more than 98% could go six months before their first refill.
However, the implant has been associated with a three-fold higher rate of endophthalmitis than monthly intravitreal injections of ranibizumab. In clinical trials, 2% of patients receiving an implant experienced at least one episode of endophthalmitis.
The European Medicines Agency (EMA) is also currently reviewing the implant for nAMD.
Meanwhile, Vabysmo’s manufacturer Roche said the therapy offered a new medicine that could improve patients’ vision, potentially lowering treatment burden with fewer injections over time.
The FDA approval was based on positive results across four Phase 3 studies in nAMD and DME. They consistently showed that patients treated with Vabysmo given at intervals of up to four months achieved non-inferior vision gains versus aflibercept given every two months in the first year.
Vabysmo was generally well tolerated in all four studies, with a favourable benefit-risk profile, Roche reported.
The most common adverse reaction (≥5%) reported in patients receiving Vabysmo was conjunctival hemorrhage (7%).
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