Bayer seeks European approval for Eylea to treat myopic CNV

The MAA is based on positive data from the Phase III MYRROR trial, which randomized 122 patients to receive either aflibercept solution 2mg or sham.

The multi-center, double-masked, sham-controlled trial was designed to evaluate the safety and efficacy of aflibercept solution, with three quarters of patients receiving an injection of aflibercept solution and one quarter receiving a sham injection.

The trial’s primary endpoint was the mean change at week 24 from baseline in best-corrected visual acuity (BCVA) as measured on the Early Treatment Diabetic Retinopathy Scale (ETDRS) eye chart.

Bayer HealthCare member of Executive Committee and head of Global Development Dr Joerg Moeller said: "Myopic CNV is a severe eye condition which can affect any age group and if left untreated can progress to legal blindness in a majority of patients.

"Treatment options that could not only prevent permanent vision loss but could also improve visual acuity have great benefits for patients with myopic choroidal neovascularization."

In September 2014, aflibercept solution for intravitreal injection was approved under the brand name Eylea in Japan to treat myopic CNV.

Eylea has also been approved in more than 80 countries to treat neovascular age-related macular degeneration (wet AMD), in around 30 countries to treat visual impairment due to macular edema secondary to retinal vein occlusion (RVO) and over 40 countries to treat visual impairment due to macular edema secondary to central retinal vein occlusion (CRVO).

Being developed under collaboration between Bayer HealthCare and Regeneron Pharmaceuticals, the injection is also approved to treat diabetic macular edema (DME) in more than 40 countries

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