EMA recommends approval of high-dose intravitreal aflibercept (Eylea®) 8mg for nAMD and macular oedema
The endorsement follows FDA approval in the United States this summer
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
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/
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
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