Bayer's Eylea Approved For Myopic CNV In Japan
Bayer HealthCare and its partner Regeneron announced that the companies have received approval from the Japanese Ministry of Health, Labor, and Welfare (MHLW) for Eylea (aflibercept solution for injection) as treatment for myopic choroidal neovascularization (myopic CNV), which, together with pathologic myopia, is the second leading cause of blindness in the country.
Eylea is a recombinant fusion protein that contains parts of human Vascular Endothelial Growth Factor (VEGF) 1 and 2. VEGF may play a role in promoting growth of abnormal new vessels in the eye, which could ultimately lead to edema. The drug serves as a soluble decoy receptor that binds to VEGF-A and placental growth factor and suppresses the binding and activation of cognate VEGF receptors. Eylea is approved in nearly 80 countries for the treatment of wet AMD and in around 60 countries for visual impairment due to macular edema secondary to central retinal vein occlusion (CRVO). Bayer has secured approval for Eylea in diabetic macular edema (DME) in over 30 countries.
The approval for Eylea in Japan is supported by conclusive data from the Phase III MYRROR study, in which the drug improved best-corrected visual acuity (BCVA) from baseline in patients with myopic CNV.
Myopic choroidal neovascularization is a disease that causes new, abnormal blood vessels to grow in the retina of patients who are severely myopic and who have pathological changes in the back of the eye. Myopic CNV results in progressive vision loss and has a poor prognosis. Patients with myopic CNV who are left untreated can progress to legal blindness within approximately 10 years.
Dr. Joerg Moeller, Member of the Bayer HealthCare Executive Committee and Head of Global Development, said, “This additional approval for EYLEA is great news for patients in Japan suffering from this potentially sight-threatening eye condition. 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.”
Earlier this month the partners announced that they are also pursuing an approval for Eylea as a treatment for macular edema secondary to branch retinal vein occlusion (BRVO) in Japan.