High-dose Eylea is approved in KOR

A higher dose version of the existing macular degeneration was approved to ensure convenience in the administration

Approved in Korea last month… dosing interval can be extended up to 5 month

Has the longest duration of effect among competitors

Dr.

 

Jae Hui Kim, Director of Future Planning of the Korean Retina Society (Kim’s Eye Hospital)

The higher-dose version of Eylea, which more than doubles the dosing interval, has been approved in Korea.

 

With the approval, Eylea now owns the longest duration of effect among its competitors.

 

Bayer held a press conference in Yeouido, Seoul, on the 28th to celebrate the approval of Eylea High Dose (8mg) in Korea.

 

Eylea is a treatment for age-related macular degeneration and diabetic macular edema developed by Bayer and Regeneron.

 

The higher dose was approved in April of this year, nearly a decade after the lower dose (2 mg) was approved in 2013 Eylea binds to the vascular endothelial growth factor (VEGF)-A and B and growth factors in the retina, inhibiting VEGF from binding to its native receptor and activating it.

 

Bayer sought to receive approval for the higher dose of Eylea due to its extended dosing interval.

 

While the current lower dose Eylea requires dosing every two months, the higher dose Eylea will extend the dosing interval to up to 5 months.

 

The approval of the high-dose Eylea was based on the PULSAR study in patients with macular degeneration and the PHOTON study in patients with diabetic macular edema.

 

The PULSAR trial, which was conducted on 1,009 patients with nAMD, compared the efficacy of high dose and low dose Eylea.

 

 Trial results showed that Eylea 8mg administered every 12 and 16 weeks were non-inferior to Eylea 2mg administered every 8 weeks in terms of best corrected visual acuity (BCVA) changes.

 

Eylea 8mg’s mean 48-week best-corrected visual acuity gain was 6.7 letters from baseline for its 12-week dosing regimen and 6.2 letters from baseline for its 16-week dosing regimen, demonstrating noninferiority to the 7.6 letters Eylea 2mg achieved at a fixed 8-week treatment interval.

 

The high dose Eylea also demonstrated noninferiority to low dose Eylea in the PHOTON study that was conducted on 658 patients with DME.

 

Results showed that Eylea 8 mg achieved comparable visual improvement to Eylea 2 mg every 8 weeks.

 

Eylea 8mg’s mean 48-week best-corrected visual acuity gain was 8.8 letters from baseline for its 12-week dosing regimen and 7.9 letters from baseline for its 16-week dosing regimen, demonstrating noninferiority to the 9.2 letters Eylea 2mg achieved at a fixed 8-week treatment interval.

 

In terms of dosing intervals, 93% of patients receiving Eylea 8 mg maintained a dosing interval of 12 weeks or longer at Week 48.

 

The high dose Eylea is expected to compete with Roche's Vabysmo in the market.

 

Vabysmo had demonstrated non-inferiority to the lower dose of Eylea at a dosing interval of once every 4 months.

 

"The high dose will be highly useful for patients whose symptoms are not controlled with the low dose Eylea," said Dr.

 

Jae Hui Kim, Director of Future Planning of the Korean Retina Society (Kim’s Eye Hospital).

 

"As Eylea is a well-verified drug, we expect the higher dose to bring similar results as well.” "Among the many available treatment options, I would first prescribe high dose Eylea to patients who have not responded to lower doses.

 

Also, if given the choice between the low and high doses of Aylia, I think most patients will want to start with the high dose because of the dosing interval benefit."