Eylea 8mg Added to PBS

From 1 October 2024, the new intravitreal injection, Eylea (aflibercept) 8 mg will be added to the Pharmaceutical Benefits Scheme (PBS) for the treatment of nAMD and DMO.¹

EYLEA 8 mg contains four times the molar dose of aflibercept as the original Eylea formulation.²

As such, the recommended dosing schedule for Eylea 8m g involves just three initial monthly injections for both nAMD and DMO, followed by extended dosing intervals of eight to 16 weeks based on visual and or anatomic outcomes.² Studies show that most nAMD and DMO patients can be effectively managed with three- or four-monthly injections of the medicine.^3,4

With Eylea 8 mg, patients may require as few as three injections per year after the loading doses

An Important Advancement

Sydney Ophthalmologist Professor Andrew Chang, who was involved in clinical trials of high-dose Eylea, welcomed the new medicine subsidy, calling it “an important advancement in retinal care”.

“The aim of increasing the molar dose of Eylea four-fold is to make each injection last longer in controlling disease,”^3,4 said Professor Chang.

“By extending treatment intervals, Eylea 8 mg may address an important unmet medical need in wet AMD and DMO.

“With intravitreal injections, treatment outcomes depend greatly on patient adherence to therapy.^4,5

“Minimising the frequency of injections, whilst not compromising on outcomes, reduces the burden of treatment and should help to maximise adherence,” he said.^3-5

Longer-lasting Disease Control

Eylea 8 mg is a vascular endothelial growth factor (VEGF) inhibitor which works to block the growth of new blood vessels and decrease the risk of fluid leaking into and under the retina.²

Professor Chang explained that “with Eylea 8 mg, the VEGF suppression time is increased, in theory providing longer-lasting disease control than Eylea 2m g”.^3,4

“Clinical trial results with Eylea 8 mg are impressive,”^2-4 he said. “Results in wet AMD demonstrated rapid and sustained fluid control, which means clinically equivalent gains to Eylea 2 mg, maintained with fewer injections.”^2-4

The Eylea 8 mg dosing regimen and PBS listing are based on results from the Phase III double-masked, active-controlled PULSAR and PHOTON clinical trials evaluating Eylea 8 mg compared to Eylea 2 mg.^2-4

Both the PULSAR trial in nAMD (N=1,009) and PHOTON trial in DMO (N=658) met their primary endpoints, with Eylea 8 mg demonstrating non-inferior and clinically equivalent vision gains at 48 weeks with both 12- and 16-week dosing regimens after only three initial monthly doses, compared to an Eylea 2 mg eight-week dosing regimen after monthly loading doses (three in PULSAR and five in PHOTON, as per current recommended dosing in the Australian Product Information).^2-4

Furthermore, 79% and 77% of nAMD patients and 91% and 89% of DMO patients, who were respectively randomised to 12- and 16-week dosing, maintained these extended dosing intervals through 48 weeks without compromising on visual gains.^3,4

After 48 weeks of treatment, the ocular and systemic safety profile of Eylea 8 mg was shown to be comparable to Eylea 2 mg. No cases of endophthalmitis or retinal vasculitis were observed in the studies with Eylea 8 mg.^3,4 The most common adverse events included conjunctival haemorrhage, eye pain, cataract, vitreous detachment, vitreous floaters, and increased intraocular pressure.^3,4

Professor Chang explained that intravitreal injections are one of the most common outpatient medical procedures performed in Australia.⁶

“With Eylea 8 mg, patients may require as few as three injections per year after the loading doses. Extended treatment intervals have the potential to increase treatment capacity in our clinics, enabling more patients to be treated,” Professor Chang concluded.

 

References

1. Schedule of Pharmaceutical Benefits. From 1 October 2024. Available at pbs.gov.au/pbs.
2. Bayer Australia. Eylea product information. 2024.
3. Brown, D. et al. Intravitreal aflibercept 8 mg in diabetic macular oedema (PHOTON): 48-week results from a randomised, doublemasked, non-inferiority, phase 2/3 trial, The Lancet, 2024. DOI: org/10.1016/S0140-6736(23)02577-1.
4. Lanzetta, P. et al. Intravitreal aflibercept 8 mg in neovascular age-related macular degeneration (PULSAR): 48-week results from a randomised, double-masked, non-inferiority, phase 3 trial, The Lancet, 2024. DOI: org/10.1016/ S0140-6736(24)00063-1.
5. McClard, CK, et al. Questionnaire to Assess Life Impact of Treatment by Intravitreal Injections (QUALITII): Development of a patient-reported measure to assess treatment burden of repeat intravitreal injections, BMJ Open Ophth, 2021;6:e000669. DOI:10.1136/bmjophth-2020-000669.
6. Broadhead, G. et al. Injections in the back of the eye: The why, the what and when to worry, Australian Journal of General Practice, 2024, 53(7). DOI: 10.31128/AJGP-08-23-6944.
7. Macular Disease Foundation Australia. Saving Sight Saves Money: Addressing treatment access and affordability in macular disease, 2024.
8. Macular Disease Foundation. About macular disease, 2024. Last accessed September 2024.
9. Macular Disease Foundation Australia. About macular disease: age-related macular degeneration, 2024. Last accessed September 2024.