Retinal diseases: from new drugs against dry and wet maculopathy, to gene therapy and artificial intelligence, here are the new retina-saving therapies arriving.
Rome, Saturday 2 December 2023 – One of the emergencies that experts will have to deal with more and more often in the coming years is age-related macular degeneration, which currently affects over 1 million Italians who have a “hole” in the center of their visual field. A panorama destined to change in the near future thanks to the arrival of new drugs and innovative intervention strategies which top international experts will take stock of during the Floretina ICOOR 2023 congress.
“Maculopathy is a pathology that significantly compromises the quality of life of patients and is very widespread: it affects 2% of Italians and increases with age. – observes Stanislao Rizzo, president Floretina ICOOR, director of the Ophthalmology Clinic of the A. Gemelli University Hospital IRCSS, Full Professor of Ophthalmology at the Catholic University of Rome –. It is now a social disease and represents the most frequent cause of low vision and visual disability after the age of 50 in the Western world.
There are two forms, the “dry” one, the most common (about 90% of all forms), and the wet or exudative one.
Until a few years ago, wet maculopathy was not considered curable, but therapeutic advances in recent years have made it possible to significantly slow down its progression and reduce its evolution.”
“Unfortunately – warns the expert – many patients arrive at the diagnosis late because they do not undergo follow-up eye examinations after the age of 50 and because they neglect the initial symptoms, mainly consisting of the slightly distorted vision of the images: if the other eye is healthy, it happens that notice it immediately and the disorder progresses, until the appearance of a potentially irreversible and indistinct dark spot in the middle of the visual field. The objective of research in recent years has therefore been to find drugs that could be more effective in delaying the progression of visual loss, also acting on other growth factors involved, and which would make treatment easier by reducing the need for intravitreal administrations” .
NEW DRUG AGAINST ‘DRY’ MACULOPATHY COMING IN 2024
Dry maculopathy 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. Following the FDA approval a few months ago, EMA approval of 2 new drugs, Pegcetacoplan and Izervay, is expected in 2024.
“In patients with maculopathy dry, in the most advanced forms, currently orphan of therapies, drugs injected intravitreally – explains Donald J. D’Amico, professor of Ophthalmology at Weill Cornell Medical College and Director of Ophthalmology at New York Presbyterian Hospital – they inactivate the inflammation mechanism which is mediated by the “complement cascade”, i.e. a linked series of inflammatory events responsible for photoreceptor degeneration. The drugs slow down the evolution of the disease in a good percentage of patients without unfortunately restoring sight”, underlines the expert.
MONOCLONAL ANTIBODIES AGAINST WET MACULOPATHY COMING IN 2024
“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.
For some years, wet form therapy 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 the so-called anti-VEGF therapies which are administered directly into the eye through intravitreal injections on a continuous basis, generally once a month, with a considerable commitment of time also on the part of the patient and his caregivers. “However, innovative therapies are finally arriving, increasingly powerful and long-acting, which will allow us to extend treatment intervals – declares Teresio Avitabile, president of the Italian Society of Ophthalmological Sciences (SISO) “This is the case of the new antibody faricimab, available for a few months and soon reimbursable by the National Health Service.
This is the first bispecific, i.e. “double target” antibodybecause in addition to acting as an anti-VEGF, it also affects a second important target, namely angipoietin-2, another substance that contributes to increasing the formation of new vessels, thus contributing to improving vascular stability and reducing the response of vessels to VEGF”.
An already used anti-VEGF monoclonal antibody will also arrive in Italy in 2024 against wet senile maculopathy and diabetic macular edema. ranibizumab, placed in a small refillable reservoir, implanted in the wall of the eye and which delivers small amounts of drug daily.
“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 by simply refilling the tank and thus reducing the number of injections needed per year,” explains Carl Coolin Awh, president of Tennessee Retina in Nashville.
The data shows that almost all patients (98%) can leave a 6-month interval between one refill and another, with the same therapeutic efficacy of monthly intravitreal treatment of the drug. Also regarding the use of faricimab, recent studies also published on The Lancet, confirm that in 60% of patients it can be administered every 4 months, rather than 2 as the current therapeutic standard. The new treatments therefore add an advantage: the extension of the interval between administrations, reducing the number of injections.
GENE THERAPY NOT ONLY TO CORRECT HEREDITARY DISEASES BUT ALSO CHRONIC RETINAL DISEASES: TRIAL UNDERWAY FOR MACULOPATHY AND DIABETIC RETINOPATHY
Gene therapy is the most advanced therapy, it constitutes a great resource for the treatment of some rare retinal diseases, and it is becoming increasingly popular. “It is now consolidated and approved – says Rizzo – gene therapy for a form of hereditary retinal dystrophy, Leber congenital amaurosis (LCA), while clinical trials are currently underway for other variants of retinitis pigmentosa, Usher syndrome, and Stargardt disease. These are pathologies for which researchers have managed to identify a specific “defective” gene that prevents certain retinal cells from functioning properly, causing vision problems that can worsen over time.
With gene therapy, these “defective” genes are replaced with healthy copies, which thus correct the error that triggered the disease, potentially for life.” Thanks to advances in science and medical technology, gene therapy will soon also be used against some serious eye diseases and not only to correct hereditary diseases. “A gene therapy is also being studied for the treatment of wet senile maculopathy, diabetic retinopathy and other chronic retinal diseases. In these cases it is not a question of replacing a diseased gene or correcting a defect, but of modifying the genome of the retinal cells by inducing to produce anti-VEGF substances, which act like the same drugs that until now we have injected from the outside once a month”.
ARTIFICIAL INTELLIGENCE AN AID FOR THE DIAGNOSIS OF DIABETIC RETINOPATHY
New possible applications for the diagnosis of retinal pathologies could come from the use of artificial intelligence. In an Italian clinical trial, conducted in Piedmont and Veneto, the effectiveness of a specific algorithm, Dairet (Diabetes Artificial Intelligence for RETinopathy) was demonstrated for the first level screening of diabetic retinopathy, a complication that affects 30% of patients diabetics. The study, published in the journal Diabetes & Obesity International Journal, demonstrated a high effectiveness of the algorithm in detecting mild and moderate cases of retinopathy, with a sensitivity ratio, i.e. ability to detect cases, equal to 91.6% for mild retinopathy and 100% for moderate retinopathy. The specificity of the test, i.e. the ability to correctly identify healthy subjects, was also very high, with a specificity ratio of 82.6%, therefore with a low rate of false positives.
Nurse Times editorial team
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