Update: Potential new treatments for nAMD and DMO

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.

Key

* After 3 loading doses

† After 4 loading doses

☨ After 5 loading doses

§ After 6 loading doses

Posted: 21 February 2022

References

1. https://www.roche.com/media/releases/med-cor-2021-10-22b.htm

2. https://www.roche.com/investors/updates/inv-update-2022-01-31.htm

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

6. https://www.roche.com/investors/updates/inv-update-2022-02-11.htm

7. https://www.pbs.gov.au/industry/listing/elements/pbac-meetings/agenda/pdf/2022/PBAC-meeting-agenda-March-2022.pdf

8. http://www.msac.gov.au/internet/msac/publishing.nsf/Content/MSAC-Meeting-March-April2022

9. https://www.pbs.gov.au/industry/listing/elements/pbac-meetings/agenda/pdf/2022/PBAC-Intracycle-meeting-agenda-MAY-2022.pdf

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