Solution for intravitreal injection Eylea from the German company Bayer is one of the newest means of treating complex eye diseases, including the “wet” form of age-related macular degeneration, diabetic macular edema, macular edema due to retinal vein occlusion.
The action of the drug suppresses the growth of abnormal newly formed vessels, prevents the accumulation of fluid in the retina and increases visual acuity. At the same time, Eylea is well tolerated by patients, and the achieved effect lasts quite a long time.
In terms of price, Eylea is comparable to other drugs of similar action (Lucentis, Avastin).
Therapy with Eylea
The active ingredient of Eylea solution is the recombinant fusion protein aflibercept. It acts as a decoy by binding to vascular endothelial growth factor (VEGF) and placenta growth factor (PIGF). The result of such a reaction is inhibition of the process of neovascularization and reduction of macular edema.
The drug is intended only for intraocular (intravitreal) injections into the vitreous body. Typically, therapy with Eylea solution, like other drugs in this series, lasts three or more months with an interval between injections of at least 30 days. However, the main difference between the drug Eylea is the ability to achieve a therapeutic effect with intravitreal injections in a standard dosage not monthly, but once every two months.
The solution is administered until the maximum level of visual acuity is achieved, which is determined through monitoring at three consecutive visits to the attending physician.
After 12 months of drug therapy, it can be continued according to objective indications.
Results of using the drug Eylea in real clinical practice
Satellite symposium “Real Life evidence of the use of anti-VEGF therapy”
September 8, 2021, Copenhagen
As part of the XVI Congress of the European Society of Vitreoretinal Specialists EURETINA – 2021, a satellite symposium “Data from real clinical practice of using anti-VEGF therapy” was held, dedicated to the results of using the drug Eylea (INN - aflibercept, solution for intravitreal injections) in conditions real clinical practice.
Why is evidence from real-world clinical practice so important? How to prepare a patient with the “wet” form of age-related macular degeneration (AMD) for treatment? What recommendations should I give and how can I support the family of a person with such a diagnosis?
Patrick Bussfeld (Switzerland), Kevin Whelan (Ireland), Faruque Ghanchi (UK), Wong Tien Yin (Singapore)
These and many other surveys were answered by leading industry experts: Professor Wong Tien Yin from the Singapore National Eye Centre, Professor Faruque Ghanchi, an ophthalmic surgeon from Bradford (UK) and Mr Kevin Whelan, Chairman of the Society Against Blindness (Ireland).
Professor Wong Tien Yin began his presentation by explaining what wet AMD is. According to experts, in the modern world about 25-30 million people suffer from this disease. However, 15 years ago, treatment for patients with this diagnosis was extremely limited, and often the patient lost central vision due to the formation of subretinal scars that damaged the retina.
Over time, scientists were able to fully explore the nature of this disease and determine its risk factors. Thus, Professor Wong Tien Yin emphasized that many smokers suffer from the “wet” form of AMD. Hereditary predisposition and excess weight can also become a risk factor for the disease. What do patients complain about when they seek help from an ophthalmologist and are diagnosed with the “wet” form of AMD? Most often, the patient notices that the image of objects is distorted or blurred. In addition, patients often cease to distinguish people’s faces and see food while eating.
Fortunately, the time when treating this disease was almost impossible has passed. The discovery of anti-angiogenic (anti-VEGF) drugs has helped reduce vision loss from wet AMD, a huge medical advance.
Anti-VEGF therapy involves intravitreal injections of a medication into the vitreous. Over the 10 years of its existence, this method of treatment has established itself as a reliable method of combating the “wet” form of AMD.
Today, ophthalmologists have a whole range of drugs for treatment. Professor Wong Tien Yin presented the results of a comparative analysis of two drugs for anti-VEGF therapy: Eylea and ranibizumab. The full study data was published in 2012 in the journal Ophthalmology of the American Academy of Ophthalmology. This study involved 2400 patients with active subfoveal choroidal neovascular membranes.
Compared with ranibizumab, aflibercept was found to have a property of fundamental importance, namely, a longer half-life. For Eylea, the time required to lose half of its pharmacological effect was twice as long as for ranibizumab. This observation meant that equal visual acuity scores with Eylea could be achieved with fewer injections.
It should be noted that these were large randomized clinical trials. All patients had different stages of the “wet” form of AMD: some sought help at the first symptoms, others came to a specialist six months after the appearance of vision problems. All study participants were of different ages with different comorbidities.
Professor Faruque Ghanchi elaborated on the results of the RAINBOW study of real clinical practice data. RAINBOW is a retrospective and prospective study of 593 patients with wet AMD from 55 institutions in France who had never previously received antiangiogenic therapy. These patients were prescribed intravitreal injections of the drug Eylea. One of the goals of the study was to understand how many patients would improve their visual acuity by three lines (15 ETDRS letters). This visual acuity allows patients to begin to recognize the faces of their interlocutors, which is a very important aspect in the life of every patient. Other equally important objectives of the RAINBOW study were to study changes in the retina and identify possible adverse events when using Eylea.
The vast majority of patients who received a loading dose of Eylea (one injection per month for the first three months) had better visual acuity scores than those who did not receive a loading dose. In comparison, patients who received a loading dose showed an improvement of 8.6 letters in visual acuity, and patients without a loading dose showed an improvement of 6 letters. These visual acuity indicators were able to be maintained for one year.
Separately, Dr. Ghanchi focused on patients who were able to achieve an improvement in vision by 17 letters according to the EDTRS table? thus achieving the visual acuity required to obtain a driving license in most countries of the European Union. Before the RAINBOW study, only 32% of study participants could read 70 letters on the EDTRS chart. After undergoing treatment with Eylea at the end of the first year, 50% of patients were able to achieve such visual acuity. This fact indicates that Eylea helps not only to improve the patient’s vision, but also to make his life more independent from other people.
Dynamic observation showed that during therapy with Eylea, retinal thickness decreases by 100 microns during the first year. This indicator also remained unchanged throughout the year.
The drug Eylea has proven itself very well in terms of safety. In this study, no patients discontinued therapy due to adverse events. According to Dr. Ghanchi, this fact makes Eylea not only highly effective, but also a safe treatment for the “wet” form of AMD.
Dr. Ghanchi also told the audience about studies in real clinical practice conducted in other countries. In the UK, Eylea was extensively studied in the VIEW study. VIEW is a study conducted in the UK in 2013–2014.
It randomized 2457 patients at least 50 years of age who had active subfoveal CNV lesions (of any subtype) secondary to AMD; patients with juxtafoveal lesions and increased vascular permeability involving the fovea region were also allowed to participate in the study; CNV extending to at least 50% of the total affected area; and BCVA in the range from 73 to 25 letters of the ETDRS table. None had previously received anti-VEGF therapy. Each patient, regardless of the degree of disease, received treatment with Eylea. One year after the start of treatment, 26.9% of patients' vision improved by 15 letters according to the ETDRS table. 96.2% of patients maintained the visual acuity obtained as a result of therapy until the end of the observation period.
The floor was then given to Mr. Kevin Whelan, Chairman of the Irish Society Against Blindness. It was founded in 1983 by a group of visually impaired people who set themselves the task of helping their fellow citizens with visual impairments.
A few years ago, Joe, an Irishman, retired since 2003, came to their community for help. He led an active lifestyle for his age: he played golf, practiced choral singing, and spent a lot of time with his grandchildren. One evening on the way home, Joe noticed that he could hardly distinguish road signs and markings. This caused serious concern, and Joe consulted an ophthalmologist. He was diagnosed with a “wet” form of AMD. This meant that Joe would have to seriously reconsider his lifestyle and plans for the future.
In addition to vision difficulties, patients with the “wet” form of AMD have many other problems and fears. For example, lack of confidence in yourself and your capabilities, a feeling of loss, fear of burdening your family, fear of no longer recognizing your children, grandchildren, friends, inability to perform actions that the patient previously did without outside help, loss of independence. Without proper psychological support, the patient's fears will very quickly affect his motivation to continue the course of treatment, and as a result, the result of the entire course of therapy.
Kevin Whelan noted that despite excellent research results in real clinical practice, patients stop therapy due to uncertainty about the success of treatment. This trend can be explained by the fact that doctors do not find the time and opportunity to tell the patient in detail about the upcoming therapy, expected results and improvements in quality of life after treatment. Some experts even recommend conducting such consultations not alone with the patient, but in the presence of one of his relatives who are able to assess the situation “from the outside.” Another important aspect that Kevin Whelan mentioned is the issue of treatment duration. It is imperative to convey to the patient that anti-VEGF therapy does not involve one injection, but a long course of injections, which can be lifelong.
A disease such as the “wet” form of AMD can also affect the relationship between spouses. It is very important to support each other during treatment. The case of Irish Joe is a story with a happy ending. Now Joe and his wife Ivy are enjoying life, communicating with their grandchildren, and nothing threatens Joe’s vision.
Material and photo prepared by Maria Tumar
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Intravitreal injections
In terms of complexity and technical details, intravitreal administration of Eylea solution is very close to microsurgical operation. In this regard, it is performed by an experienced surgeon in a sterile operating room.
In preparation for the injection, nearby skin is treated with a disinfectant solution. Epibulbar (drip) anesthesia is administered, which completely blocks the sensitivity of the scleral surface.
The injection is performed with a special syringe, which is used to partially puncture a certain area of the ciliary body to a depth of 3 mm. The drug is injected by slowly pressing the piston, after which the needle is removed. No puncture fixation or sutures are required.
At the end of the procedure, monitoring of intraocular pressure is mandatory. If it increases significantly, paracentesis can be performed - a puncture of the cornea in the limbal region.
At the final stage, special drops with antimicrobial and anti-inflammatory effects are instilled into the eye, which must continue to be dripped according to a certain pattern for the next three days at home.
Education:
Candidate of Medical Sciences, defended in 2005 in two specialties: ophthalmology and rehabilitation medicine, Moscow (Helmholtz Institute of Eye Diseases, Institute of Regenerative Medicine)
Ophthalmologist of the highest category since 2004, confirmed the category in 2021.
1992 – graduated from the Military Medical Faculty at the Nizhny Novgorod Medical Institute with a degree in general medicine.
1995 – internship in ophthalmology at the main hospital of the Baltic Fleet in Baltiysk, Kaliningrad region
1999-2001 - residency in ophthalmology at the Department of the Military Medical Academy. CM. Kirov, St. Petersburg
2020 — Moscow International Higher Business School MIRBIS, Moscow Medical management, Medicine
Side effects and contraindications
As a rule, Eylea is well tolerated by patients, including the elderly. Side effects occur rarely (approximately 1 case per 10 administrations).
The most commonly reported undesirable consequences of drug injections are: pain in the eye, hemorrhage under or into the conjunctiva, increased IOP, swelling of the cornea or eyelid, moderate headache.
If these side effects occur, as well as any other unpleasant sensations in the eye or changes in vision, you should see a doctor immediately.
Intravitreal injections of Eylea solution are not prescribed for:
- Infectious inflammations of the eyes.
- Intolerance to the substance aflibercept.
- Risk of stroke.
In addition, the drug is not used in children and women during pregnancy and breastfeeding.
Training
2019 — RMAPO MOKB, Certification course in ophthalmology
2018 - Issues of occupational pathology and organization of preventive medical examinations National Technological, Occupational Pathology
2017 — Health Organization St. Petersburg University, Administration and Management
2008 — Laser surgery, phacoemulsification of cataracts, MNTK named after Fedorov, Ophthalmosurgery
2005 - postgraduate studies at the Institute of Eye Diseases named after. Helmholtz, ophthalmology
2004 - Surgical treatment of glaucoma at the Military Medical Academy of SAINT PETERSBURG, Ophthalmosurgery
2004 - The use of lasers in ophthalmology (laser coagulation of the retina, laser treatment of glaucoma, PRK,) VMedA, St. Petersburg, Laser surgery.
What diseases are treated with IVV?
The intravitreal injection method is widely used in the treatment of the following diseases:
- Wet form of age-related macular degeneration (AMD)
- Diabetic retinopathy
- Postthrombotic retinopathy
- Macular edema with complicated myopia (myopia).
The listed diseases pose a serious danger to the patient's vision. In advanced cases, they lead to partial or complete blindness. However, timely examination and treatment will protect you from an unfavorable outcome.
Intravitreal injection is a modern method of treating the retina, which has already established itself as one of the most effective methods of treatment.
Preparation and carrying out the procedure
- A few days before IVI, on the recommendation of the attending physician, it is necessary to adjust the schedule for taking certain medications and instill antibacterial drops if necessary.
- The procedure itself is carried out under local anesthesia (drops). After the procedure, the patient’s intraocular pressure readings must be taken. In case of increased IOP, the attending physician prescribes drops to reduce it. The patient is sent home on the same day.
- The next day you need to come to the clinic for an examination and instill drops for a week according to the regimen prescribed by the doctor.
The recovery period after the procedure lasts for a month, and after that you must come for a follow-up examination.
Preparations for intravitreal injections and their action
- Lucentis
is a drug used to treat the wet form of age-related macular degeneration (AMD), as well as diabetic macular edema and other circulatory disorders of the fundus. The active components of the drug localize the affected areas, relieve swelling, stop uncontrolled vascular growth and hemorrhages. The course of treatment usually includes 3 injections with intervals of 1 month. - "Eylea"
is an analogue of "Lucentis", which is also used to prevent pathological vascular growth and reduce retinal edema. - Ozurdex
is a drug for the treatment of thrombosis (blockage) of large retinal veins. It reduces inflammation and swelling, normalizes capillary permeability and blocks abnormal vascular growth. Usually the effect is achieved after one injection of Ozurdex. A repeat procedure may be scheduled after approximately 3-6 months.
Intravitreal injections require mandatory monitoring of dynamics after the procedure, so we immediately set dates for follow-up examinations for our patients.
Doctors at Dr. Belikova's Eye Clinic always approach each patient carefully and select the treatment that is most suitable for you.
Remember that any problem is easier to prevent than to eliminate, so examinations by an ophthalmologist should be regular.
But for almost every eye disease today there is an effective treatment method. We keep up with the times and are always ready to offer you all available ways to restore your vision. Related articles:
- What is IVV and why is it needed?
How to treat age-related macular degeneration of the retina?
In general, the macula is a region of visual receptors that perform the functions of central vision. They contain lutein and zeaxanthin, which protect the highly sensitive elements of the retina from the damaging effects of the blue range of the spectrum. These pigments have a characteristic color and form an area called the “yellow spot”.
The older a person is, the less of these substances remains to protect retinal cells. This leads to noticeable damage to the photoreceptor elements and partial or even complete loss of vision. As a result, people have difficulty distinguishing objects, faces, cannot read, and cannot even distinguish colors.
