Bayer Announces EU Approval of Aflibercept 8mg Prefilled Syringe for nAMD and DME

▎WuXi AppTec Content Team Report

On September 9, Bayer announced that the European Medicines Agency (EMA) had approved in the EU.Prefilled SyringeFor the administration of Eylea™ 8mg (114.3mg/ml injection).The new pre-filled syringe OcuClick™ will provide ophthalmologists with an efficient and portable method to precisely administer a 70-microliter dose of Eylea 8mg for the treatment of neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME).Germany will be among the first markets to launch the new pre-filled syringe.

Christine Roth, Executive Vice President of Bayer's Pharmaceuticals Division, Head of Global Product Strategy and Commercialization, and member of the Executive Committee, said: "As a leader in the ophthalmology field, we tirelessly pursue customer-centric solutions.OcuClick Helps Doctors Easily and Accurately Control Eylea 8mg Dosage, an Innovation；Eylea 8mg is approved for use in suitable patients.Extend the treatment interval up to five months"The powerful combination of these two innovative products demonstrates that innovative products can directly benefit patients."

Eylea 8mg (Aflibercept 8mg, 114.3mg/ml Injection) has been approved in over 40 markets for the treatment of neovascular (wet) age-related macular degeneration and diabetic macular edema. Registration applications for Eylea 8mg are ongoing in other markets.

Aflibercept Injection Solution is a recombinant fusion protein made by fusing the extracellular domains of human vascular endothelial growth factor (VEGF) receptors 1 and 2 with the Fc domain of human IgG1 to create an intravitreal injection solution. Aflibercept is a soluble decoy receptor that binds to VEGF-A and placental growth factor (PGF), inhibiting the binding and activation of these factors with natural VEGF receptors. Vascular endothelial growth factor (VEGF) is a naturally occurring cytokine in the human body. In normal individuals, it promotes the formation of new blood vessels, supporting the growth of tissues and organs within the body. It is also associated with abnormal neovascularization in the eye, increasing vascular permeability, which leads to retinal edema.

According to publicly available information from Bayer, Eylea 8mg has been developed to extend treatment intervals, thereby reducing the disease burden, with efficacy and safety comparable to the standard treatment Eylea 2mg. Based on the successful pivotal clinical trial data from PULSAR and PHOTON, the European Union has approved Eylea 8mg for the treatment of nAMD and DME.Approval of Eylea 8mg for Extended Treatment Intervals up to Five Months in Appropriate PatientsIn the PULSAR and PHOTON studies, Eylea 8mg dosing every 12 weeks and every 16 weeks demonstrated non-inferiority in the primary endpoint of best-corrected visual acuity (BCVA) benefit compared to aflibercept 2mg fixed dosing every 8 weeks.