The European Medicines Agency (EMA) has granted approval for a pre-filled syringe designed for the administration of Eylea 8 mg (aflibercept 8 mg, 114.3 mg/ml solution for injection) within the European Union. This approval aims to simplify and enhance the accuracy of treatments for neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME).
The new OcuClick pre-filled syringe is designed to provide ophthalmologists with a more efficient and precise method for delivering the required 70-microliter dose of Eylea 8 mg. This advancement is expected to streamline the treatment process, benefiting both healthcare professionals and patients.
Enhanced Precision and Control
According to University Professor Dr. med Oliver Zeitz, the pre-filled syringe represents a significant advancement in administering eye injections. "This simple, easy, and accurate application method will greatly benefit ophthalmologists and patients, allowing for fast and precise treatment," he stated.
Christine Roth, Executive Vice President at Bayer, emphasized the company's commitment to customer-oriented solutions. "OcuClick offers the doctor excellent control, precision, and simplicity for the administration of Eylea 8 mg," she said. "This innovative ophthalmic syringe, combined with the Eylea 8 mg solution approved for extended treatment intervals of up to five months in appropriate patients, shows how our innovation can directly benefit patients."
Clinical Efficacy and Extended Treatment Intervals
Eylea 8 mg was developed to reduce the burden of frequent treatments while maintaining comparable efficacy and safety to the standard Eylea 2 mg. Data from the pivotal PULSAR and PHOTON clinical trials supported the EMA approval, demonstrating non-inferior best-corrected visual acuity at extended intervals of 12 and 16 weeks compared to Eylea 2 mg at a fixed 8-week interval in patients with nAMD and DME.
Disease Burden and Current Treatment Landscape
Neovascular AMD is a leading cause of irreversible blindness, affecting approximately 10% of the 170 million people worldwide living with AMD. DME, a complication of diabetic retinopathy, affects around 27 million people globally. Current treatments aim to manage the abnormal blood vessel growth and leakage associated with these conditions.
About Aflibercept
Aflibercept is a recombinant fusion protein that acts as a soluble decoy receptor, binding to VEGF-A and Placental Growth Factor (PGF) to inhibit the activation of their receptors. This mechanism helps to reduce the formation of new blood vessels and the associated edema in the eye.
Global Availability
Eylea 8 mg has already been approved in over 40 markets for the treatment of nAMD and DME, with further regulatory applications underway. Germany is expected to be among the first countries to launch the pre-filled syringe.
