Bayer Files For 4th Eyelea Indication In EU
Bayer HealthCare has submitted a marketing authorization application to the European Medicines Agency (EMA) for Eyelea as treatment for visual impairment due to macular edema secondary to branch retinal vein occlusion (BRVO).
Aflibercept solution for injection (Eyelea) is a recombinant fusion protein and acts as a soluble decoy receptor that binds VEGF-A and placental growth factor (PlGF), inhibiting the binding and activation of their cognate VEGF receptors. The drug has already been approved under the brand name Eyelea for the treatment of patients with neovascular age-related macular degeneration (wet AMD) and the treatment of visual impairment due to macular edema secondary to central retinal vein occlusion (CRVO).
Dr. Joerg Moeller, member of the Bayer HealthCare executive committee and head of global development, said, “BRVO is a common retinal vascular disorder with an estimated 14 million people affected worldwide, and it is a severe disease which is potentially blinding if not treated early and appropriately. The submission is an important milestone as it marks the fourth regulatory submission in the EU for aflibercept solution for injection into the eye in the past few years.”
The MAA submitted to the EMA is supported by positive results from the Phase III VIBRANT trial. The study met its primary endpoint; patients treated with a monthly 2 mg. injection of the aflibercept solution saw restoration of 15 letters (three lines) in best corrected visual acuity (BCVA) from baseline at week 24. The drug also met a key secondary endpoint of 17.0 letter mean improvement over baseline in BCVA against a 6.9 letter mean improvement in patients who received laser treatment.
In addition to its MAA for the expansion of Eyelea indication, the company has also filed for a DME indication for the drug in the EU.
In addition to this new marketing authorization, the company was recently in the news when it announced the upcoming appointment of Dieter Weinand, former President of Global Commercialization & Portfolio Management at Otsuka Pharmaceutical Development & Commercialization, as President of Bayer HealthCare.