Will twice-yearly Bayer's 'Eylea' become available in KOR?

The MFDS is reviewing the expanded indication for high-dose Eylea

The efficacy of the drug was demonstrated through the PULSAR·PHOTON studies

Product photo of Eylea

Twice-yearly administration of 'Eylea,' used to treat eye disease, is anticipated to be possible in South Korea.

 

The Ministry of Food and Drug Safety (MFDS) is conducting a review of the expanded indication for the administration of Bayer Korea's high-dose Eylea (aflibercept) 8 mg at intervals of up to 6-months.

 

The approval is expected in the second half of this year.

 

The detailed indication under review is vision disorder due to neovascular or wet age-related macular degeneration (nAMD) or diabetic macular edema (DME).

 

Eylea 8 mg is an anti-vascular endothelial growth factor (VEGF) with increased sustainability achieved by increasing the molar dose of the existing 2 mg product by four times.

 

This drug's 6-month interval administration obtained expanded approval from the European Commission (EC).

 

The efficacy of Eylea's long-term administration was demonstrated through the PULSAR study, which involved macular degeneration, and through the PHOTON study, which involved DME.

 

In the extension period (weeks 96-156) of both studies, patients randomized to Eylea 8mg at week 0 maintained their vision and anatomical improvements.

 

Notably, 24% of nAMD patients and 28% of DME patients maintained their final treatment interval at six months after three years.

 

The safety profile of Eylea 8mg remained favorable throughout the three years in both studies, consistent with the established safety profile of Eylea 2mg.

 

No new safety issues were observed in the long-term safety data from either study.

 

The data includes patients who switched from Eylea 2 mg to 8 mg at week 96.

 

Meanwhile, high-dose Eylea was approved in South Korea in 2024 and received insurance reimbursement starting in October of the same year.

 

The current reimbursement criteria include patients with nAMD and DME who meet the conditions of Hemoglobin A1c (HbA1c) 10% or less and a minimum central retinal thickness of 300 µm.

 

The current dosing interval involves monthly injections for the first three months, which can then be extended up to 16 weeks, based on the doctor's judgment, following the results of a vision or anatomical examination.