Eylea 8mg, a higher dose of aflibercept, is now approved in Australia and is being added to the Pharmaceutical Benefits Scheme (PBS) from 1 October 2024.
It means people suffering from neovascular age-related macular degeneration (nAMD) and diabetic macular oedema (DMO) can now be treated with fewer injections through the subsidised medicines scheme, without compromising outcomes and safety, a statement from Bayer Australia said.
In 2012, Australia became the first country to make the original Eylea formulation a government-funded pharmaceutical for the treatment of nAMD. Today, it remains one of the costliest drugs on the PBS with the government spending $444 million on the product in 2020-21.
The new Eylea 8mg, approved by the Therapeutic Goods Administration (TGA) in June 2024, contains four times the molar dose of aflibercept as the original Eylea formulation.
As such, the recommended dosing schedule involves 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.
Bayer citied studies showing that most nAMD and DMO patients can be effectively managed with three- or four-monthly injections of the medicine.
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,” said Prof Chang.
“By extending treatment intervals, Eylea 8mg may address an important unmet medical need in wet AMD and DMO.
“With intravitreal injections, treatment outcomes depend greatly on patient adherence to therapy.
“Minimising the frequency of injections, whilst not compromising on outcomes, reduces the burden of treatment and should help to maximise adherence,” he said.
Eylea 8mg 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.
Prof Chang explained that “with Eylea 8mg, the VEGF suppression time is increased, in theory providing longer-lasting disease control than Eylea 2mg”.
“Clinical trial results with Eylea 8mg are impressive,” he said. “Results in wet AMD demonstrated rapid and sustained fluid control, which means clinically equivalent gains to Eylea 2mg, maintained with fewer injections”.
The Eylea 8mg dosing regimen and PBS listing are based on results from the Phase 3 double-masked, active-controlled PULSAR and PHOTON clinical trials evaluating Eylea 8mg compared to Eylea 2mg.
Both the PULSAR trial in nAMD (N=1,009) and PHOTON trial in DMO (N=658) met their primary endpoints, with Eylea 8mg 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 2mg eight-week dosing regimen after monthly loading doses.
Furthermore, 79% and 77 per cent 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.
After 48 weeks of treatment, the ocular and systemic safety profile of Eylea 8mg was shown to be comparable to Eylea 2mg.
Prof Chang said that intravitreal injections were one of the most common outpatient medical procedures performed in Australia.
“With Eylea 8mg, 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,” he said
Mr Manoj Saxena, CEO of Bayer ANZ and country division head for the Pharmaceutical Division, added: “More than a decade ago, Eylea transformed the treatment of these common sight-stealing diseases.
“We have remained focused on practice-changing innovations in retinal care and are proud to deliver a treatment option that reduces the burden on patients, providing sustained vision gains with fewer injections.”
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