Today, World Sight Day, the AIFa, Italian Medicines Agency has approved the reimbursement of aflibercept 8 mg (114.3 mg/solution for injection), a innovative treatment for 2 important eye diseases: neovascular age-related macular degeneration (nAmd) and diabetic macular edema (Dme). Bayer announced this in a note where it specifies that aflibercept 8 mg has already obtained the green light from the American Agency (Fda) in the United States in August 2023 and from the European one (EMA) last January.
The treatment is the only one approved in the EU with extended administration intervals of up to 5 months in nAmd and Dme, resulting in a reduction in the number of injections for patients. Furthermore, the initial loading phase involves, again for the first time, only 3 monthly injections both for patients suffering from nAmd and for patients with Dme – today the initial monthly doses are 5 – with a further decrease in the burden, therefore of the impact, in the management of the pathology. The treatment thus improves the patients’ quality of lifebut also of caregivers.
nAmd is a rapidly progressing eye disease that, if left untreated, can lead to vision loss within a few months. Dme is an 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 efficacy and safety of aflibercept 8 mg was demonstrated in the pivotal Pulsar and Photon clinical trials. The data confirms that the treatment can be administered every 12 to 16 weeks, without compromising visual results. These studies have shown truly remarkable success rates: 79% of patients with nAmd and 89% of those with Dme maintain an interval between administrations of at least 16 weeks up to 2 years of treatment. This evidence was further confirmed by ‘post hoc’ analyzes of the registration studies presented during the Euretina 2024 Congress, recently held in Barcelona.
“In clinical studies – states Paolo Lanzetta, director of the Ophthalmology Clinic of the University of Udine and first author of the Pulsar pivotal study in Lancet – aflibercept 8 mg demonstrated significant and clinically relevant benefits, allowing patients to obtain long-lasting control of the disease. This means that the drug is able to offer visual gains with prolonged treatment intervals and rapid and sustained fluid control over time, with a safety profile comparable to the comparator drug aflibercept 2 mg”.
Adds Francesco Bandello, professor of Ophthalmology at the Vita-Salute San Raffaele University of Milan: “This innovation represents a significant step forward in the management of retinopathies, with the opportunity to reduce injections and visits, thus improving the quality of life of patients patients and their caregivers. Clinicians, for the first time, can extend the intervals between injections up to 5 months in both conditions. Non-adherence to treatments remains an important problem for people suffering from retinal diseases, because it limits their effectiveness. Aflibercept 8 mg can help improve compliance with therapies and, consequently, benefits for patients.” Reducing the number of injections, while maintaining the effectiveness of the treatment, can also have a positive impact on the healthcare organisation, allowing healthcare needs to be met more effectively.
In September, aflibercept 8 mg received further recognition: the EMA approved a new pre-filled syringe, OcuClick*, which makes administration even simpler and more effective. “This innovative syringe represents a great progress for intravitreal injections, making the treatment quicker and more accurate – underlines Massimo Nicolò, head of the Retina and maculopathy center of the University of Genoa, San Martino polyclinic – This simple, easy and precise application method will be of great benefit to ophthalmologists and patients. OcuClick* is, in fact, able to offer the doctor excellent control and precision in the administration of aflibercept 8 mg”. Aflibercept 8 mg – concludes the note – was developed by Bayer together with Regeneron, which holds exclusive rights to aflibercept 2 mg and aflibercep 8 mg in the United States, Bayer has licensed exclusive commercialization rights outside the United States.
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