The European Commission authorized the marketing of aflibercept 8 mg (114.3 mg/ml solution for injection) for the treatment of two important retinal diseases: neovascular (wet) age-related macular degeneration (nAmd) and the reduction of vision caused by diabetic macular edema (Dme). The drug is approved for administration at prolonged treatment intervals of up to 4 months, after 3 initial monthly doses in both nAmd and Dme (pathology where today the initial monthly doses are 5). Furthermore – explains a note released by Bayer – in patients with stable visual results, treatment intervals of up to 5 months can be taken into consideration. For this reason it is the only treatment approved in the EU with extended intervals of up to 5 months in nAmd and Dme with consequent reduction in the number of injections for patients.
“Aflibercept 8 mg – states Jean-François Korobelnik, professor of ophthalmology and director of the Department of Ophthalmology of the University Hospital of Bordeaux and investigator of the Pulsar pivotal study – constitutes an important step forward in the treatment of retinopathies, as it provides greater control and longer lasting of the disease. Clinicians, based on their opinion, can extend the treatment intervals to their patients up to 4 months, immediately after the 3 initial monthly doses. This – he adds – not only means fewer intravitreal injections and doctor visits for patients, but could also help improve patient management in clinical practice across Europe.”
Neovascular (wet) age-related macular degeneration (nAmd) – the note details – is an eye disease which progresses rapidly and which, if left untreated, can lead to vision loss in a few months: it is in fact one of main causes of irreversible blindness and vision reduction worldwide. The disease occurs when abnormal blood vessels and fluid leakage (exudate) proliferate under the macula, the part of the eye that allows for clear central vision along with details, which can damage and scar the macula, causing vision loss. Diabetic macular edema (Dme) is a common ocular complication of people with diabetes. The condition occurs when high blood sugar levels damage the eye's blood vessels, which release fluid into the macula. This can lead to vision loss and, in some cases, blindness.
“The approval of aflibercept 8 mg in the European Union – underlines Michael Devoy, Chief Medical Officer of Bayer's Pharmaceuticals Division – marks an important milestone in responding to unmet needs to reduce the burden of retinal disease management for patients. Developed Based on the standard of care in retinal therapies, aflibercept 2 mg” the 8 mg dosage “allows patients to enjoy the benefit of less frequent injections, with efficacy and safety comparable to those of aflibercept 2 mg”.
The green light in Europe for the therapy is based on the positive results of the Pulsar clinical study in nAmd and the Photon study in Dme. Both studies met the primary endpoint of non-inferiority in terms of best corrected visual acuity (Bcva) with aflibercept 8 mg, administered every 12 or 16 weeks, compared to aflibercept 2 mg, administered every 8 weeks, until week 48. In these studies, the safety profile of the 8 mg dose was consistent with the established one of 2 mg.
The European approval – concludes the note – will be followed by the request to the Italian Medicines Agency (Aifa) for marketing authorization in our country, the dispensing regime and reimbursement. Aflibercept 8 mg was first approved by the US Agency (FDA) in August 2023, following which Bayer submitted authorization applications in other markets. The drug is developed by the German pharmaceutical together with Regeneron, which holds the exclusive rights for aflibercept 2 mg and aflibercept 8 mg in the United States, while Bayer has licensed the exclusive marketing rights in the rest of the world.
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