Jakarta, 10 October 2019, World Sight Day (WSD) – that is commemorated on October 10 – is an important moment to increase the knowledge of everyone in the whole world on the importance of healthy sight organ, along with diseases that can cause blindness and vision impairment.

One of the causes of blindness and vision impairment is Diabetes Mellitus. The disease is known as Diabetic Retinopathy (DR). This disease is a microvascular complication of diabetes mellitus with a fairly high prevalence rate. Based on research data conducted in several regions in Indonesia, the estimated prevalence of DR is 42.6%. At least 24,600 people will be found with diabetic retinopathy and about 10% of these will experience blindness. This number is expected to increase in 2030 with an estimated 98,400 people suffering from diabetes and around 11,000 of them are blind. Considering that most blindness due to DR is a permanent and untreatable, therefore the prevention and treatment are important².

Further stages of DR will cause Diabetic Macular Edema (DME). People with DME experience decreasing vision quality, such as the presence of black dot, blurry vision, and wavy vision. When left untreated immediately, complimented with uncontrolled blood glucose level, the process to blindness can potentially be faster.

DME occurs when fluid leaks into the center of the macula, the light-sensitive part of the retina responsible for sharp, direct vision. Fluid in the macula can cause severe vision loss or blindness.

In Indonesia, there is a study on 1,184 respondents suffering from Diabetes Mellitus type 2, age of more than 30 years, who live in urban and village area in Yogyakarta, Central Java. Study shows high prevalence of DR and VTDR (Vision Threatening Diabetic Retinopathy). There is about 1 out 4 adultadults who suffer from VTDR and there is 1 out of 12 people suffering from VTDR who will experience blindness².

DM’s patients who chronically have the disease, regular changes of blood sugar can cause damage to the small blood vessels in the retina and complications with severe consequences in terms of morbidity^4,5. To maintain and improve the quality of eyesight, it is essential for the patients to be immediately given DME appropriate treatment in order to maintain their eyesight. Without the treatment, by using eye acuity examination (ETDRS), DME patients can lose two rows of their eyesight within the first 2 years. With early diagnosis and appropriate treatment, a patient's likelihood of vissionvision loss can be stabilized and even restored, thus enabling them to revert to normal life^6-7.

Chairman of Indonesian Vitreoretinal Society (INAVRS), Prof. dr. Arief S Kartasasmita, SpM (K), M.Kes, MM, Phd explains, “It is important for patients with Diabetes Mellitus to check up their retina, especially those who have been diagnosed for more than five years. The main cause of retinopathy is combination of high blood pressure, high blood glucose level and cholesterol. General complication of Diabetic Retinopathy is Diabetic Macular Edema, or commonly known as DME⁴. The risk of DME development is closely linked to how long have the patient been living with Diabetes Mellitus and the degree of severity of Diabetic Retinopathy^1,3. DME and DR are general microvascular complication on people with Diabetes Mellitus.” He then added that regular eye screening check with Retina Specialist is an important part in the treatment for people with Diabetes Mellitus. Retina check up on people with Diabetes Mellitus type 1 should take place 5 years after diagnosed. Meanwhile people with Diabetes Mellitus type 2 should immediately check their retina once they are diagnosed with Diabetes Mellitus. Retina check upcheckup must be done once every 1 – 2 year or according to Doctor Retina Specialist recommendation. Retina check upcheckup is easy and not painful. The procedure is different than regular eye check. Ophthalmologist will use a special tool to see the back area of the eye. Normally, eyedropseye drops will be administered to dilate the pupil, hence easier to see the retina”.

Prof. Arief underline, ”It is very important to educate continuesly the Ophthalmologist and Doctor Retina Specialist on how to diagnose DME earlier.”

The Cipto Mangunkusomo Hospital (RSCM) is now doing active screening by placing fundus photo screening equipment in internist polyclinic. In the future, PERDAMI hopes that more active screening will take place, especially in secondary and tertiary hospitals, and in eye hospitals.”

There are two objectives of DME patientspatients’ treatment, first is the stability of eyesight to prevent worsening the retina, edema, and hyper-reflective repair foci. Another objective is restorative therapy by maintaining or improving visual acuity correction or Best Corrected Visual Acuity (BCVA) and edema. There are several treatments for DME such as a special laser that can close the capillary leak, reduce swelling and steroids. There is also the latest treatment with anti-VEGF therapy. VEGF is a blood vessel growth factor. When injected into the eye, this drug inhibits VEGF resulting in the formation of new blood vessels and swelling can be reduced. Some research has shown that anti-VEGF therapy is more effective in improving visual acuity correction than laser or steroids treatment for DME. The earlier the treatment, the bigger chance the patients can be saved.

DME is one of the most frequent reasons for severe vision impairment in the working-age population⁶. As the majority of people under 50 years old are still working, vision impairment may lead to loss of productivity and earnings⁴. Vision impairment related to DME may lead to daily tasks and role difficulties, decreased patient quality of life, and depression^8,9. The direct annual cost per patient with DME is approximately twice as high as those of patients with diabetes alone⁹. Visual impairment goes beyond the individual. Social and financial costs have an impact on the social and financial burden of families, communities and within the country⁴.

According to International Diabetes Mellitus Federation (IDF) Atlas 2017: Diabetes Mellitus epidemic in Indonesia shows tendency to increase. Indonesia is ranked number six in the world after China, India, USA, Brazil and Mexico, where 10.3 million people suffer from Diabetes Mellitus within the age range of 20 – 79 years old. Basic Health Survey (Riset Kesehatan Dasar – Riskesdas) shows significant increase on Diabetes Mellitus prevalence, from 6.9% in 2013 to 8.5% in 2018; hence the estimation of people suffer from Diabetes Mellitus in Indonesia is up to 22 million people.

It is estimated that DR health treatment in Indonesia by 2025 will reach up to USD 8.9 billion or three times fold compared to health treatment spent in 2017 (USD 2.4 billion)¹¹. Therefore, it is important for DM’s patients to have regular retina screening and examination to identify the presence of DR and DME in early stage and itas progression, also to have the therapy in time.

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References:

<sub>1. http://atlas.iapb.org/vision-trends/diabetic-retinopathy/
2. http://www.yankes.kemkes.go.id/read-retinopati-diabetik-pergeseran-paradigma-kebutaan-pada-era-milenial-5984.html
3. https://www.sciencedirect.com/science/article/pii/S0002939417302714?via%3Dihub
4. IDF. Diabetes Melitus Atlas. Sixth Edition. 2013, http://www.idf.org/Diabetes Melitusatlas/download-book.
5. Prevalence of lower extremity diseases associated with normal glucose levels, impaired fasting glucose, and Diabetes Melitus among U.S. adults aged 40 or older. Diabetes Melitus Res Clin Pract. 2007;77:485-488
6. Ciulla, T.A. et al. Diabetic retinopathy and diabetic macular edema: pathophysiology, skrining, and novel therapies. Diabetes Melitus Care 2003;26:2653-64.
7. Boyer, D. et al. Anti-vascular Endothelial Growth Factor Therapy for Diabetic Macular Edema. Ther Adv in Endo and Metab. 2013;4(6):151-169.
8. Davidson, J.A. et al. How the diabetic eye loses vision. Endocrine.2007;32(1):107-116.
9. De Groot, M. et al. Association of depression and Diabetes Melitus complications: a meta-analysis.Psychosom Med. 2001; 63(4):619-630.
10. Vision for the future. Parliament magazine. 2011;320:22.
11. https://www.researchgate.net/publication/334312053_The_estimated_healthcare_cost_of_diabetic_retinopathy_in_Indonesia_and_its_projection_for_2025</sub>
 

About Aflibercept / anti-VEGF

Vascular Endothelial Growth Factor (VEGF) is a naturally occurring protein in the body. Its normal role in a healthy organism is to trigger formation of new blood vessels (angiogenesis) supporting the growth of the body's tissues and organs. It is also associated with the growth of abnormal new blood vessels in the eye, which exhibit abnormal increased permeability that leads to edema.

Aflibercept solution for injection is a recombinant fusion protein, consisting of portions of human VEGF receptors 1 and 2 extracellular domains fused to the Fc portion of human IgG1 and formulated as an iso-osmotic solution for intravitreal administration.

Aflibercept acts as a soluble decoy receptor that binds VEGF-A and Placental Growth Factor (PGF) and thereby can inhibit the binding and activation of their cognate VEGF receptors.

Aflibercept has been approved in approximately 100 countries for five indications to treat patients with wAMD and patients with visual impairment due to: macula edema following retinal vein occlusion (RVO; branch RVO or central RVO) and diabetic macular edema (DME). Aflibercept has also been approved for the treatment of myopic choroidal neovascularization. Around 25 million vials of Aflibercept have been sold since launch worldwide resulting in approximately 3.6 million patient years of experience.

Bayer and Regeneron Pharmaceuticals, Inc. are collaborating on the global development of Aflibercept. Regeneron maintains exclusive rights to Aflibercept in the United States. Bayer has licensed the exclusive marketing rights outside the United States, where the companies share equally the profits from sales of Aflibercept, except for Japan where Regeneron receives a percentage of net sales.

About Bayer

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