The Australian Therapeutic Goods Administration (TGA) has approved Eylea 8mg, a higher dose of aflibercept for adults with neovascular aged-related macular degeneration (nAMD) and diabetic macular oedema (DME).
The TGA registration – on 14 June 2024 – follows approvals in the US and Europe in late 2023 on the back of the pivotal PULSAR and PHOTON studies, two double-masked, active-controlled trials evaluating Eylea 8mg compared to Eylea injection 2 mg.
It has previously been reported the PULSAR and PHOTON were two double-masked, active-controlled pivotal trials evaluating Eylea 8mg compared to Eylea injection 2 mg.
Both the PULSAR trial in nAMD (N=1,009) and PHOTON trial in DME (N=658) met their primary endpoint, 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 eight-week dosing regimen after initial monthly doses (three in PULSAR and five in PHOTON).
The vast majority of patients randomised at baseline to Eylea 8mg 12- or 16-week dosing regimens (following three initial monthly doses) could maintain these dosing intervals through 48 weeks.
The most common adverse reactions (≥3%) reported with Eylea 8 mg were cataract, conjunctival hemorrhage, intraocular pressure increase, ocular discomfort/eye pain/eye irritation, vision blurred, vitreous floaters, vitreous detachment, corneal epithelium defect, and retinal hemorrhage.
By introducing a higher dose of aflibercept, it’s hoped this will reduce the treatment burden associated with frequent intravitreal injections. To understand the dosing regime in Australia for Eylea 8mg, refer to the TGA product information.
Eylea 8 mg is being jointly developed by Bayer and Regeneron. Regeneron maintains exclusive rights to the product in the US, with Bayer licensing the exclusive marketing rights outside the country, including Australia.
More reading
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FDA clears higher dose Eylea; approvals sought in other markets
