The time interval between one treatment and another is lengthening for those suffering from maculopathy. The European Commission has, in fact, granted marketing authorization in the European Union for the 8 mg injectable drug aflibercept for the treatment of two important retinal diseases: neovascular (wet) age-related macular degeneration and of vision caused by diabetic macular edema.
Festival Salute 2023. First of all, let’s see each other carefully: eye diseases and maculopathies
Two pathologies that put sight at risk
Neovascular (wet) age-related macular degeneration (nAMD) is a rapidly progressing eye disease that, if left untreated, can lead to vision loss within a few months. nAmd is a leading cause of irreversible blindness and vision impairment worldwide and affects people as they age. This disease occurs when abnormal blood vessels proliferate and leak fluid under the macula, the part of the eye that allows for clear central vision along with details.
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The disease that puts sight at risk
This fluid can damage and scar the macula, causing vision loss. 196 million people are affected worldwide and this figure is expected to reach 288 million by 2040. Approximately 10-15% of people affected by AMD will develop the advanced form.
Equally insidious and widespread is diabetic macular edema (Dme), 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. Currently, 146 million people worldwide suffer from diabetic retinopathy, a pathology that can evolve into a more serious condition, diabetic macular edema, which affects approximately 21 million people globally.
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A therapy to be taken at longer intervals
The approval of the new formulation of the drug aflibercept meets the needs of patients who will now be able to take a break of four or five months with a smaller number of injections, but with efficacy and safety comparable to those of the same drug in the formulation to be 2 mg. Aflibercept 8 mg, in fact, is approved for administration at prolonged treatment intervals of up to 4 months, after 3 initial monthly doses in both neovascular macular degeneration and diabetic macular edema (a pathology where today the initial monthly doses are 5). Furthermore, in patients with stable visual outcomes, treatment intervals of up to 5 months may be considered.
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Positive impact on medical visits
The EU approval is based on the positive results of the Pulsar clinical study in nAMD and the Phoyon study in Dme.
“Aflibercept 8 mg represents an important step forward in the treatment of retinopathies, as it provides greater and longer-lasting control of the disease. Clinicians, based on their opinion, can extend the treatment intervals for their patients up to 4 months, immediately after the initial 3 monthly doses,” he explains Jean-François Korobelnikprofessor of ophthalmology and director of the Department of Ophthalmology at the University Hospital of Bordeaux and investigator of the Pulsar study.
“This not only means fewer intravitreal injections and doctor visits for patients, but could also help improve patient management in clinical practice across Europe,” concludes the expert. European approval will be followed by a request to the national health authorities (Aifa) for marketing authorization in Italy, the dispensing regime and reimbursement.
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