The European Commission has granted marketing authorization in the European Union (EU) for the Eylea 8 mg (aflibercept 8 mg, 114.3 mg/ml solution for injection). This approval opens new doors in the treatment of wet age-related macular degeneration (AMD) and visual impairment due to diabetic macular edema (DME).
Eylea 8 mg distinguishes itself by its approval for administration at extended treatment intervals of up to every 4 months, following an initial course of 3 monthly doses. For patients exhibiting stable visual outcomes, physicians may consider extending treatment intervals up to 5 months. Notably, Eylea 8 mg stands as the sole treatment in the EU approved for extended intervals of up to 5 months in both wet AMD and DME cases.
Professor Jean-François Korobelnik, Head of the Department of Ophthalmology at the University Hospital of Bordeaux in France, expressed the significance of this advancement. In a company news release, he stated, "Eylea 8 mg is an important advancement in retinal care as it provides greater and longer lasting control of the disease. Doctors may extend their patients interval to 4 months, right after 3 initial monthly doses, based on their judgement. This then does not only mean less eye injections and doctor visits for patients but could also help to mitigate capacity constraints faced in clinical practices in Europe.”
The EU approval is underpinned by the positive outcomes from two pivotal clinical trials – the PULSAR trial in wet AMD and the PHOTON trial in DME. Both trials successfully met their primary endpoint of noninferior best-corrected visual acuity (BCVA) changes with aflibercept 8 mg compared to the existing aflibercept 2 mg (Eylea 40 mg/ml) treatment regimen. The safety profile of aflibercept 8 mg was found to be consistent with the established safety profile of Eylea (aflibercept 2 mg).
Aflibercept 8 mg, initially approved by the FDA under the brand name Eylea HD in August 2023, has garnered attention globally. Bayer, in collaboration with Regeneron, is actively pursuing regulatory approvals in additional markets. It's worth noting that Regeneron holds exclusive rights to Eylea (aflibercept 2 mg) and Eylea HD in the United States, while Bayer has secured exclusive marketing rights outside the United States, with profit-sharing arrangements for both Eylea and Eylea 8 mg sales. The collaborative efforts of these pharmaceutical companies promise a new era of advanced retinal care globally.
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