Drugs, ok EU Commission to brolucizumab for diabetic macular edema

The European Commission (EC) has approved brolucizumab 6 mg for the treatment of visual disturbances due to diabetic macular edema (Dme). This is the second EC-approved indication for brolucizumab, which has already been approved since 2020 for the treatment of wet age-related macular degeneration. The decision – Novartis reports in a note – applies to all 27 member states of the European Union (EU), as well as to Iceland, Norway and Liechtenstein. “Diabetic macular edema is a dangerous clinical manifestation of diabetes-related retinopathy. It affects 5 to 7% of people with diabetes mellitus, which unfortunately are many, over 4 million in Italy, a figure destined to grow in proportion to the increase in the prevalence of the disease “, explains Agostino Consoli, president of the Italian Diabetes Society ( Sid), full professor of Endocrinology at the ‘G. d’Annunzio’ University of Chieti and head of the territorial Uoc of Endocrinology and Metabolic Diseases of the Pescara Ausl. “In diabetic retinopathy the blood vessels, damaged by the high concentration of glucose in the blood , allow the leakage of liquids that accumulate in the macula, causing edema and over time leading to important visual deficits. This is why a treatment with anti-Vegf agents such as brolucizumab, molecules capable of keeping fluid leakage under control, is particularly effective. “The approval is based on the first year of the first year of the Phase III studies Kestrel and Kite randomized and in double-blind, which met the primary endpoint of non-inferiority to aflibercept in the change in best corrected visual acuity (Bcva) from baseline. “Brolucizumab, a small, single-chain humanized antibody fragment, is characterized by excellent tissue penetration and a high capacity to eliminate fluid from the retina”, comments Rosangela Lattanzio, president of the Italian Society of the Retina (Sir), head of the Medical Retina Service – vasculopathies of the San Raffaele hospital in Milan. “The results of efficacy, safety and interval between administrations, highlighted by the Kestrel and Kite studies – he continues – show a significant improvement in anatomical parameters and visual function due to the use of brolucizumab also for this new indication. As retina specialists we can only be satisfied to be able to enrich our therapeutic armamentarium and to be able to improve the visual health and quality of life of our patients, thanks to a truly effective treatment in keeping the retina dry ”. According to the approved prescribing information – the note details – after the loading phase of five doses with injections six weeks apart, doctors can tailor treatment for patients with AMD based on their disease activity, assessed by sight and from the parameters relating to liquids. In patients without disease activity, physicians should consider 12-week intervals between brolucizumab treatments; in patients with disease activity, physicians should consider 8-week intervals between treatments.