The European Commission recently gave the green light for the marketing of aflibercept 8 mg, an important step forward in the treatment of retinal diseases, allowing treatments with extended intervals of up to 5 months. This approval covers the treatment of two serious eye conditions: neovascular age-related macular degeneration (nAMD) and reduced vision caused by diabetic macular edema (DME).
The drug, developed by Bayer in collaboration with Regeneron, is an injectable solution of aflibercept 8 mg (114.3 mg/ml) and represents a significant evolution in the management of retinopathies. Its approval allows for greater flexibility in treatments, reducing the number of intravitreal injections and doctor visits for patients.
According to information released by Bayer, aflibercept 8 mg is approved for administration at extended intervals up to 4 months, after the first three initial monthly doses, in both nAMD and Dme. Additionally, for patients with stable visual outcomes, treatment intervals of up to 5 months may be considered. This represents a significant benefit for patients, reducing the burden of managing retinal diseases and improving quality of life.
Jean-François Korobelnik, professor of ophthalmology and director of the Department of Ophthalmology at the University Hospital of Bordeaux, underlines that aflibercept 8 mg constitutes an important step forward in the treatment of retinopathies, offering greater and longer-lasting control of the disease. The possibility of extending treatment intervals up to 4 months after the initial monthly doses represents a significant advance in clinical practice.
nAmd is a progressive eye disease that can lead to vision loss within a few months if not treated promptly. The approval of aflibercept 8 mg offers an effective solution to combat this pathology, providing positive results in clinical trials, as highlighted in the Pulsar study.
Diabetic macular edema is a common complication in people with diabetes, which can lead to vision loss and, in severe cases, blindness. Aflibercept 8 mg proved to be as effective and safe as aflibercept 2 mg, but with the notable advantage of requiring fewer injections, thus improving treatment adherence.
The Chief Medical Officer of Bayer’s Pharmaceuticals Division, Michael Devoy, highlights that the approval of aflibercept 8 mg marks a significant milestone in responding to the needs of patients suffering from retinal diseases, offering less frequent but equally effective injections.
After European approval, Bayer will proceed with the request to the Italian Medicines Agency (Aifa) for marketing authorization in Italy, defining the dispensing regime and reimbursement. Aflibercept 8 mg was initially approved by the US FDA in August 2023, and regulatory submissions are ongoing for other markets. With this approval, Bayer continues to position itself as a leader in innovation in the field of retinal therapies, providing advanced solutions to improve the lives of patients suffering from serious eye diseases.
YOU MAY ALSO BE INTERESTED IN: Pneumonia alarm in children: 2 cases of mycoplasma in Italy – experts urge caution, A new therapy for Fanconi Bickel syndrome, Covid and flu, few vaccinations, cases are growing. Risks for the fragile