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a new drug against maculopathy is coming

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One of the emergencies that experts will have to deal with more and more often in the coming years is the age-related macular degenerationwhich is currently of interest over 1 million Italians: for them reading is almost impossible, driving a utopia and even walking and shopping a feat due to what is referred to as a “hole” in the center of the field of vision.

A panorama destined to change in the near future thanks to thearrival of new drugs e you innovative intervention strategies on which the experts will take stock during the second National Congress of the Italian Society of Ophthalmological Sciences.

In maculopathy it is a pathology that significantly compromises the quality of life of patients and is very widespread: it concerns 2% of Italians and increases with age – observes Stanislao Rizzo, director of the eye clinic of the A. Gemelli IRCSS University Hospital, and member of the Siso board of directors. – It’s now one social disease and represents the most frequent cause of low vision and visual impairment after age 50in the western world. There are two forms, the “dry” onethe most common (about 90% of all forms), and moist or exudative. Umid maculopathy until a few years ago it was not considered curable, but the therapeutic advances of recent years have made it possible to considerably slow down its progression and reduce its evolution”.

“Unfortunately – warns the expert – many patients arrive at the diagnosis late because they do not undergo eye examinations after the age of 50 and because they neglect the initial symptoms, mainly constituted by the slightly distorted vision of the images: if the other eye is healthy, it happens that one does not notice it immediately and the disturbance progresses, until arriving at the appearance of a potentially irreversible and indistinct dark spot middle of the field of view. The goal of research in recent years has therefore been to find drugs that could be more effective in delaying the progression of visual loss by also acting on other growth factors involved, and that would make treatment easier, reducing the need for intravitreal administrations” .

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Dry maculopathy it is due to the formation of yellowish deposits under the macula with atrophy of the retinal tissue and the reduction of central vision is generally more gradual and slowly progressive. Approval by the EMA is expected this year, following the FDA approval a few months ago, of a new drug, Pegcetacoplan, a therapy currently being used for patients with a rare blood disorder. “In patients with dry maculopathy, in the most advanced forms, currently without therapies, the drug, injected intravitreally, – explains Rizzo – goes to inactivate the mechanism of inflammation which is mediated by the “complement cascade”, i.e. a series chain of inflammatory events responsible for photoreceptor degeneration. The drug could slow its evolution without unfortunately restoring sight. The phase I, II and III trials have shown a regression of the areas of retinal atrophy in the face of good safety profiles”, he underlines the expert. “Wet” maculopathy is caused by an abnormal growth of new vessels under the macula, the central part of the retina responsible for fine vision and vision impairment in this form can occur suddenly. The wet form therapy for some years has made use of very powerful drugs directed against a growth factor that facilitates the proliferation of new vessels in the macular region. These are so-called anti-VEGF therapies that are administered directly into the eye (intravitreal injections) on an ongoing basis, generally once a month, with considerable time commitment also on the part of the patient. “I am but finally Innovative therapies are on the way, increasingly powerful and with a long duration of action, which will allow us to lengthen the treatment intervals”, declares Francesco Bandello, director of the Vita-Salute San Raffaele eye clinic in Milan and member of the Siso board of directors. “This is the case with the new antibody faricimab, which has been available for a few months and will soon be reimbursable by the National Health Service. This is the first bispecific antibody, i.e. with a “double target” because, in addition to acting as an anti-VEGF agent, it also affects a second important target, i.e. angipoietin-2, another substance which helps to increase the formation of new vessels, contributing to this way to improve vascular stability and reduce vessel response to VEGF”.

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Also in Italy, again in 2023, against wet senile maculopathy and diabetic macular edema, an already used anti-VEGF monoclonal antibody, ranibizumab, inserted in a small refillable tank, implanted in the wall of the eye and which delivers small daily amount of drug. “The innovative therapeutic strategy is to surgically implant small reservoirs in the eye that gradually release the drug inside. This could extend the retreatment interval to six months, simply by refilling the reservoir and thus reducing the number of injections needed per year”.

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