The FINANCIAL — Bayer HealthCare has submitted an application for marketing authorization of aflibercept solution for intravitreal injection for the treatment of myopic choroidal neovascularization (myopic CNV) to the European Medicines Agency (EMA).
“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,” said Dr. Joerg Moeller, Member of the Bayer HealthCare Executive Committee and Head of Global Development. “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.”
Pathologic myopia and the associated myopic CNV is a common cause of blindness globally in people under the age of 40 associated with severe myopia (short sightedness) and more prevalent in Asian countries than in European countries. Myopic CNV is associated with high degrees of myopia and leads to progressive vision loss. Myopic CNV has a poor prognosis and, if left untreated, can, within approximately 10 years, progress to legal blindness in a majority of patients, according to Bayer.
The application is based on positive data from the Phase 3 MYRROR study in myopic CNV. Patients receiving aflibercept solution for injection had a mean improvement in best-corrected visual acuity (BCVA) from baseline at week 24 of 12.1 letters, while patients receiving sham injections lost 2 letters (p<0.0001), as measured on the Early Treatment Diabetic Retinopathy Scale (ETDRS) eye chart, a standard chart used in research to measure visual acuity.
Aflibercept solution for intravitreal injection has been approved already under the brand name EYLEA® in Japan for the treatment of myopic CNV in September 2014. In addition, EYLEA has been approved in more than 80 countries for the treatment of patients with neovascular age-related macular degeneration (wet AMD), in around 30 countries for the treatment of visual impairment due to macular edema secondary to retinal vein occlusion (RVO) and over 40 countries for the treatment of visual impairment due to macular edema secondary to central retinal vein occlusion (CRVO). EYLEA is also approved for the treatment of diabetic macular edema (DME) in more than 40 countries. Over three million doses of EYLEA have been administered since launch worldwide. For the treatment of macular edema secondary to branch retinal vein occlusion (BRVO), an application for marketing authorization has been submitted in Japan.
Bayer HealthCare and Regeneron Pharmaceuticals, Inc. are collaborating on the global development of EYLEA. Regeneron maintains exclusive rights to EYLEA in the United States. Bayer HealthCare licensed the exclusive marketing rights outside the United States, where the companies share equally the profits from sales of EYLEA, except for Japan where Regeneron receives a royalty on net sales.
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