EMA recommends approval of high-dose intravitreal aflibercept (Eylea®) 8mg for nAMD and macular oedema

After considering the EMA’s recommendation, the European Commission will decide whether to issue final approval of the drug. Image credit: ©Brenda Blossom – stock.adobe.com

On Friday, Bayer AG announced that the European Medicines Agency had recommended approval of 8 mg aflibercept (Eylea®), developed in conjunction with Regeneron. Previously, the EMA had approved Eylea in a dosage of 2 mg.¹ After considering the EMA’s recommendation, the European Commission will decide whether to issue final approval of the drug.

Earlier this year, in the United States, the FDA issued approval for 8 mg aflibercept (EYLEA HD) following the 48-week results of the PULSAR and PHOTON clinical trials.² The treatment has been assessed for age-related macular degeneration (AMD), diabetic macular oedema (DME) and diabetic retinopathy (DR).

The results from the PULSAR and PHOTON trials indicate a longer interval between doses with 8 mg aflibercept compared to 2 mg aflibercept. The extended periods between dosing could significantly lower patient burden. Both the PULSAR trial in wet AMD (N=1,009) and PHOTON trial in DME (N=658) met their primary endpoint, with aflibercept injection 8 mg demonstrating non-inferior and clinically equivalent vision gains at 48 weeks with both 12- and 16-week dosing regimens after only 3 initial monthly doses, compared to an EYLEA 8-week dosing regimen after initial monthly doses (3 in PULSAR and 5 in PHOTON).

According to previous reporting from the US approval, the most common adverse reactions reported in patients treated with the 8 mg dosage (≥3%) included: cataract, conjunctival hemorrhage, intraocular pressure increased, ocular discomfort/eye pain/eye irritation, vision blurred, vitreous floaters, vitreous detachment, corneal epithelium defect and retinal hemorrhage.

Outside the US, Bayer has licensed the exclusive marketing rights to both aflibercept injection 2 mg and aflibercept injection 8 mg. Regulatory proceedings for aflibercept 8mg are also underway in Japan.

References

1. Burger L. European regulator endorses high-dose version of Bayer eye drug Eylea. Reuters. 10 November, 2023. Accessed 13 November, 2023. https://www.reuters.com/business/healthcare-pharmaceuticals/european-regulator-endorses-high-dose-version-bayer-eye-drug-eylea-2023-11-10/

2. Hutton D. FDA approves aflibercept injection 8mg for treatment of wet AMD, DME, DR. Ophthalmology Times. 19 August, 2023. Accessed 13 November, 2023. https://www.ophthalmologytimes.com/view/hed-fda-approves-aflibercept-injection-8mg-for-treatment-of-wet-amd-dme-dr