European Commission Grants Label Extension for Eylea 8 mg Allowing 6-Month Treatment Intervals
The European Commission (EC) has approved a label extension in the European Union (EU) for aflibercept 8 mg (Eylea), enabling extended treatment intervals of up to 6 months for patients with neovascular (wet) age-related macular degeneration (nAMD) and visual impairment due to diabetic macular oedema (DME).
Commenting on the EC’s decision in a company press release, Christine Roth, Executive Vice President at Bayer, stated:
“Extended treatment intervals with Eylea 8 mg can significantly decrease the frequency of injections and clinic visits for patients without compromising efficacy. This translates to decreased burden of disease for patients and may enhance adherence to treatment. For ophthalmologists, it allows for greater capacity to treat additional patients. Given its distinctive product profile, Eylea 8 mg has the potential to establish a new standard of care for retinal diseases.”
Approval Supported by Long-Term Data from PULSAR and PHOTON Trials
Bayer reported that the EC’s decision was based on additional positive results from the third-year open-label extension phase of the pivotal clinical trials PULSAR in nAMD and PHOTON in DME. In both extension phases, which covered study weeks 96 to 156, patients who were originally randomized to Eylea 8 mg at week 0 maintained their visual and anatomic improvements. At the end of three years, 24% of patients with nAMD and 28% of patients with DME had a last assigned dosing interval of 6 months.
Continued Favorable Safety Profile
The company also highlighted that the safety profile of Eylea 8 mg continued to be favorable in the third year of both studies and remained consistent with that of Eylea 2 mg.
Joint Development and Commercial Rights
Eylea 8 mg, known as Eylea HD in the United States, is being jointly developed by Bayer and Regeneron. Regeneron maintains exclusive rights to Eylea 2 mg and Eylea HD in the United States, while Bayer holds exclusive marketing rights outside the United States. In these markets, Bayer and Regeneron equally share the profits from sales of Eylea 2 mg and Eylea 8 mg.
