2023-09-22 08:23:56
In Spain, it is estimated that the prevalence of early age-related macular degeneration (AMD) is 15% in people between 65 and 74 years old; 25%, in those between 75 and 84 years old, and 30%, in those over 85 years old.
About 7% of diabetic patients develop diabetic macular edema, while advanced macular degeneration (neovascular and atrophic) affects between 2% and 3% of those over 65 years of age, “which is a lot of people because in our country an important segment of the population is in that age range,” points out Alfredo García Layana, director of the Ophthalmological Service of the Clínica Universidad de Navarra and president of the Spanish Retina and Vitreous Society (SERV).
They are problems that disrupt the daily lives of those who suffer from them and are the main causes of visual impairment and blindness in people over 50 years of age in Europe. Its treatment poses complications. Patients with neovascular AMD and diabetic macular edema have to undergo intraocular drug injections every one, two or three months. Those who suffer from atrophic macular degeneration must make do with nutritional supplements enriched with vitamins, but their pathology lacks specific treatment.
All in all, a paradigm shift is occurring. “Little by little we are taking steps. 23 years ago there was no treatment for AMD, we have improved a lot in this area with the arrival of the 21st century,” says Professor Francisco Gómez-Ulla, founder and medical director of the Gómez-Ulla Ophthalmological Institute of Santiago de Compostela.
The Ministry of Health has approved funding for Vabysmo (Faricimab), the first biospecific humanized antibody for intraocular use, which targets two different pathways involved in neovascular or wet AMD and DME. Studies have shown that almost 80% of treated patients achieve a treatment interval of every 3 or 4 months, keeping both diseases under control.
Brolucizumab was the last drug to appear on the market for wet AMD. ““It has facilitated the prolongation of treatment intervals as it is more powerful, but its widespread use is somewhat diminished because there is a small percentage of patients, less than 1%, who develop an inflammatory reaction, and more reviews must be done additional”, explains the president of the SERV.
The mechanism of action of the drugs currently used focuses on blocking vascular endothelial growth factor (VEGF), while Vabysmo is designed to block not only VEGF but also angiopoietin-2 (Ang-2), another pathway. of the disease that contributes to vision loss and destabilization of blood vessels.
García Layana emphasizes that Vabysmo allows increasing the durability of the effects with an excellent safety profile: “It is an equally powerful drug that allows treatment intervals to be lengthened, potentially reaching four months, in addition to having a very good safety profile. ”.
In the case of diabetic macular edema, Vabysmo inhibits exudation from retinal vessels through the same mechanism of action, also lengthening the periods between injections and with virtually no side effects.
The reduction of healthcare pressure on the health system, patient anxiety regarding intraocular injections, and overload for companions are other positive side effects of the incorporation of the new medication.
“A revolution”
On the other hand, but no less important, is the appearance of Syfovre and Izervay, aimed at atrophic (dry) AMD. “It represents a revolution because we have a treatment for a disease that was orphaned and it also represents a way to work, we see where we can go,” says the director of the Ophthalmological Service of the CUN and president of the SERV.
The US Food and Drug Administration (FDA) has already approved both medications and they are expected to be available in Spain next year. “It is one of the most important events in the field of retina in more than a decade. It reminds me of what happened at the beginning of this century with photodynamic therapy for wet AMD, which was later relegated with drugs,” highlights Francisco Gómez-Ulla, whose clinic has participated in international studies.
The effect of both drugs is to slow down the evolution of the disease: “They do not improve vision, but they slow down the progression. We must bear in mind that the evolution of this AMD with geographic atrophy can last many years, so these treatments can greatly prolong the time of useful vision,” explains Alfredo García Layana.
Professor Gómez-Ulla expresses himself along the same lines: “It slows down the progression of the disease, which is very important because if we manage to make an early diagnosis, we can preserve vision much longer.” Likewise, he values the contribution of progression markers to identify cases that evolve more quickly: “We will be able to detect those that are at greater risk of losing central vision and it is with these that we have to act more quickly.”
The mechanism of these medications has to do with the complement system, which defends human beings from external aggressions but at the same time can cause subclinical inflammation of the retina, producing the death of pigment epithelium cells. Syfovre and Izervay modulate the complement system by targeting the source of retinal cell death and maintaining the beneficial properties of this system.
García Layana warns, however, of the new challenge that arises for the national health system “because they are treatments for life and intended for many people.”
Change of concept and early treatment
Age-related macular degeneration is a pathology that progresses with age and that awakens in many affected people the fear of going blind. For this reason, Alfredo García Layana explains that there has been a change in concept “because the distinction between wet and dry AMD creates confusion and concern in patients.” The specialist adds that the current classification distinguishes between initial AMD, with some macular drusen, but good vision; intermediate, with larger drusen and changes in the retinal pigment epithelium; and advanced, with more significant vision losses and where we must speak of neovascular (wet) and macular degeneration with geographic atrophy (dry).
“These terms must be clarified because the initial and intermediate forms are very common, but the advanced form of either type occurs in approximately 2%-3% of those over 65 years of age,” comments García Layana, who has clarified that Not all macula diseases cause total blindness: “Central vision is lost, but peripheral vision is maintained.”
In any case, the director of the Ophthalmological Service of the Clínica Universidad de Navarra and president of the Spanish Society of Retina and Vitreous, has given capital importance to early diagnosis and treatment: “They are key because chronic damage to the retina is irreversible. It is necessary to monitor the transition from intermediate to advanced AMD and act at the first symptoms to avoid significant consequences. If we delay the treatment of wet AMD for two or three months, the consequences can be permanent.”
Metamorphopsia (seeing deformed objects and faces, or straight lines as if they were wavy), is the most characteristic sign of this escalation to advanced AMD. Maria R. Lagoa
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