Advertisement Japan approves Bayer's Eylea to treat myopic choroidal neovascularization - Pharmaceutical Business review
Pharmaceutical Business review is using cookies

ContinueLearn More
Close

Japan approves Bayer’s Eylea to treat myopic choroidal neovascularization

Japan' Ministry of Health, Labour and Welfare (MHLW) has approved Bayer HealthCare's Eylea (aflibercept solution for injection) to treat myopic choroidal neovascularization (myopic CNV).

Bayer HealthCare’s in Germany

Pathologic myopia and the associated myopic CNV is the second most common cause of blindness, in this country.

Eylea approval is based on positive data from the Phase III MYRROR trial carried out in patients with myopic CNV.

A total of 122 patients were given either EYLEA 2mg or sham in the double-masked, sham-controlled trial.

The data showed that patients receiving Eylea had a mean improvement in best-corrected visual acuity (BCVA) from baseline at week 24 of 12.1 letters, compared to a loss of two letters in patients receiving sham injections.

Bayer HealthCare Member of the Executive Committee and head of Global Development Dr Joerg Moeller said myopic CNV has a poor prognosis and more treatment options are needed to address the urgent medical need for these patients, many of whom are of working age.

"This additional approval for EYLEA is great news for patients in Japan suffering from this potentially sight-threatening eye condition," Moeller said.

"A treatment option that could not only prevent permanent vision loss but could also improve visual acuity would have great benefits for patients with pathologic myopia."

Eylea has been approved in many countries to treat neovascular age-related macular degeneration (wet AMD) as well as for visual impairment due to macular edema secondary to central retinal vein occlusion (CRVO).

The company is collaborating with Regeneron Pharmaceuticals on the global development of Eylea


Image: Bayer HealthCare’s research site at Berlin, Germany. Photo: courtesy of Bayer AG.