The European Medicines Agency (EMA) has approved the new pre-filled syringe for administering Eylea™ 8 mg (114.3 mg/ml solution for injection) in the European Union. The pre-filled syringe, branded OcuClick™, will offer ophthalmologists a streamlined and precise method for delivering the 70-microliter dose of Eylea 8 mg for treating neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME). Germany is set to be one of the first markets to launch this new syringe.
“We are excited to introduce the Eylea 8 mg pre-filled syringe, which marks a significant advancement in eye injection administration,” said University Professor Dr. med Oliver Zeitz, Senior Consultant and Site Manager of the Department of Ophthalmology at Charité Campus Benjamin Franklin in Berlin, Germany. “This user-friendly and precise application method will greatly enhance the efficiency of treatments for both ophthalmologists and patients.”
Christine Roth, Executive Vice President of Global Product Strategy and Commercialization at Bayer, commented, “As a leader in ophthalmology, we are committed to delivering customer-focused solutions. OcuClick provides doctors with excellent control and precision for administering Eylea 8 mg. This innovative syringe, along with the extended treatment intervals of up to five months approved for Eylea 8 mg in suitable patients, exemplifies how our innovations directly benefit patients.”
Eylea 8 mg has been designed to reduce the disease burden and extend treatment intervals while maintaining comparable efficacy and safety to the standard Eylea 2 mg. The approval in the EU follows successful results from the pivotal PULSAR and PHOTON trials, which demonstrated that Eylea 8 mg was non-inferior to Eylea 2 mg in maintaining best-corrected visual acuity at extended intervals of 12 and 16 weeks compared to the fixed 8-week interval of Eylea 2 mg.
Eylea 8 mg (aflibercept 8 mg; known as Eylea HD in the United States) is a joint development by Bayer and Regeneron. While Regeneron holds exclusive rights to Eylea 2 mg and Eylea HD in the U.S., Bayer has the exclusive marketing rights outside the U.S. and shares equally in the profits from sales of both Eylea 2 mg and Eylea 8 mg following regulatory approvals.
