With burden and cost being major problems for patients receiving anti-vascular endothelial growth factor (VEGF) intravitreal injections, new treatments facing PBAC scrutiny may offer valuable benefits.
The US FDA recently approved two treatments: Susvimo® (ranibizumab port delivery system) for neovascular age-related macular degeneration (nAMD),1 and Vabysmo® (faricimab) for nAMD and diabetic macular oedema (DMO).2
Susvimo® is a proprietary formulation of ranibizumab administered via an intraocular implant. Vabysmo® is a bispecific antibody that neutralises VEGF-A and angiopoietin-2. Both aim to offer longer treatment intervals, fewer injections and less patient burden than Lucentis® (ranibizumab) or EYLEA® (aflibercept).
One-year results from the faricimab nAMD3 and DMO4 studies were recently published in The Lancet.
The TENAYA and LUCERNE trials in nAMD compared aflibercept every 8 weeks* with faricimab at personalised treatment intervals (PTI) up to 16 weeks†. Visual and anatomic outcomes were similar for both agents, with comparable safety profiles. Up to 45% of patients received faricimab at a 16-week dosing interval by week 48.
In patients with DMO, YOSEMITE and RHINE compared aflibercept every 8 weeks☨ with faricimab every 8 weeks§ or PTI up to 16 weeks†. Again, visual and anatomic outcomes were comparable across all groups with similar safety profiles. Up to 52% of patients in the faricimab PTI group achieved a 16-week dosing interval by week 52.
The ARCHWAY trial of ranibizumab via intraocular implant for nAMD5 showed patients can expect to maintain visual acuity while receiving refills every 24 weeks. This outcome was non-inferior and equivalent to that for patients treated with 4-weekly intravitreal ranibizumab.
Trial updates for both treatments were presented at the recent Angiogenesis 2022 virtual meeting,6 confirming the extended treatment intervals were retained out to 2 years.
Ranibizumab PDS (Susvimo®) will be reviewed by both the PBAC7 and MSAC8 in March 2022. Faricimab (Vabysmo®) is on the PBAC agenda for May 2022.9
If approved, both products could offer patients reduced treatment burden and cost. However, a recent paper sounded a note of caution that treatment intervals of 12 weeks or more at 2 years were associated with reduced treatment persistence over 5 years.10
Addressing the complex problems of access to treatment, adherence and persistence, and affordability requires a combination of efforts including new therapeutic options to ensure that fewer patients develop preventable but irreversible vision loss and blindness.
* After 3 loading doses
† After 4 loading doses
☨ After 5 loading doses
§ After 6 loading doses
Posted: 21 February 2022
3. Heier et al. Efficacy, durability, and safety of intravitreal faricimab up to every 16 weeks for neovascular age-related macular degeneration (TENAYA and LUCERNE): two randomised, double-masked, phase 3, non-inferiority trials. Lancet 2022. doi:10.1016/S0140-6736(22)00010-1
4. Wykoff et al. Efficacy, durability, and safety of intravitreal faricimab with extended dosing up to every 16 weeks in patients with diabetic macular oedema (YOSEMITE and RHINE): two randomised, double-masked, phase 3 trials. Lancet 2022. doi:10.1016/S0140-6736(22)00018-6
5. Holekamp et al. Archway Randomized Phase 3 Trial of the Port Delivery System with Ranibizumab for Neovascular Age-Related Macular Degeneration. Ophthalmology 2021. doi:10.1016/j.ophtha.2021.09.016
10. Teo et al. Longer treatment intervals are associated with reduced treatment persistence in neovascular age related macular degeneration. Eye 2022. doi:10.1038/s41433-022-01957-z