StemCell Therapy

OverviewWhat is Diabetes?What is diabetes?

Diabetes is a condition that happens when your blood sugar (glucose) is too high. It develops when your pancreas doesnt make enough insulin or any at all, or when your body isnt responding to the effects of insulin properly. Diabetes affects people of all ages. Most forms of diabetes are chronic (lifelong), and all forms are manageable with medications and/or lifestyle changes.

Glucose (sugar) mainly comes from carbohydrates in your food and drinks. Its your bodys go-to source of energy. Your blood carries glucose to all your bodys cells to use for energy.

When glucose is in your bloodstream, it needs help a key to reach its final destination. This key is insulin (a hormone). If your pancreas isnt making enough insulin or your body isnt using it properly, glucose builds up in your bloodstream, causing high blood sugar (hyperglycemia).

Over time, having consistently high blood glucose can cause health problems, such as heart disease, nerve damage and eye issues.

The technical name for diabetes is diabetes mellitus. Another condition shares the term diabetes diabetes insipidus but theyre distinct. They share the name diabetes because they both cause increased thirst and frequent urination. Diabetes insipidus is much rarer than diabetes mellitus.

There are several types of diabetes. The most common forms include:

Other types of diabetes include:

Diabetes is common. Approximately 37.3 million people in the United States have diabetes, which is about 11% of the population. Type 2 diabetes is the most common form, representing 90% to 95% of all diabetes cases.

About 537 million adults across the world have diabetes. Experts predict this number will rise to 643 million by 2030 and 783 million by 2045.

Symptoms of diabetes include:

Its important to talk to your healthcare provider if you or your child has these symptoms.

Additional details about symptoms per type of diabetes include:

Too much glucose circulating in your bloodstream causes diabetes, regardless of the type. However, the reason why your blood glucose levels are high differs depending on the type of diabetes.

Causes of diabetes include:

Long-term use of certain medications can also lead to Type 2 diabetes, including HIV/AIDS medications and corticosteroids.

Diabetes can lead to acute (sudden and severe) and long-term complications mainly due to extreme or prolonged high blood sugar levels.

Acute diabetes complications that can be life-threatening include:

Blood glucose levels that remain high for too long can damage your bodys tissues and organs. This is mainly due to damage to your blood vessels and nerves, which support your bodys tissues.

Cardiovascular (heart and blood vessel) issues are the most common type of long-term diabetes complication. They include:

Other diabetes complications include:

Living with diabetes can also affect your mental health. People with diabetes are two to three times more likely to have depression than people without diabetes.

Healthcare providers diagnose diabetes by checking your glucose level in a blood test. Three tests can measure your blood glucose level:

To screen for and diagnose gestational diabetes, providers order an oral glucose tolerance test.

The following test results typically indicate if you dont have diabetes, have prediabetes or have diabetes. These values may vary slightly. In addition, healthcare providers rely on more than one test to diagnose diabetes.

Diabetes is a complex condition, so its management involves several strategies. In addition, diabetes affects everyone differently, so management plans are highly individualized.

The four main aspects of managing diabetes include:

Due to the increased risk for heart disease, its also important to maintain a healthy:

You cant prevent autoimmune and genetic forms of diabetes. But there are some steps you can take to lower your risk for developing prediabetes, Type 2 diabetes and gestational diabetes, including:

Its important to note that there are some diabetes risk factors you cant change, such as your genetics/family history, age and race. Know that Type 2 diabetes is a complex condition that involves many contributing factors.

The prognosis (outlook) for diabetes varies greatly depending on several factors, including:

Chronic high blood sugar can cause severe complications, which are usually irreversible. Several studies have shown that untreated chronic high blood sugar shortens your lifespan and worsens your quality of life.

In the United States, diabetes is the eighth leading cause of death. A large number of people with diabetes will die from a heart attack or stroke.

However, its important to know that you can live a healthy life with diabetes. The following are key to a better prognosis:

Studies show that people with diabetes may be able to reduce their risk of complications by consistently keeping their A1c levels below 7%.

If you havent been diagnosed with diabetes, you should see a healthcare provider if you have any symptoms of diabetes, such as increased thirst and frequent urination.

If you have diabetes, you should see your provider who helps you manage diabetes (such as an endocrinologist) regularly.

A note from Cleveland Clinic

Being diagnosed with diabetes is a life-changing event, but it doesnt mean you cant live a happy and healthy life. Managing diabetes involves consistent care and diligence. While itll likely be very overwhelming at first, over time youll get a better grasp on managing the condition and being in tune with your body.

Be sure to see your healthcare provider(s) regularly. Managing diabetes involves a team effort youll want medical professionals, friends and family on your side. Dont be afraid to reach out to them if you need help.

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Diabetes: What It Is, Causes, Symptoms, Treatment & Types

A number of healthtech startups claim they can reverse Type 2 diabetes. But caveats apply, caution doctors  Economic Times

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A number of healthtech startups claim they can reverse Type 2 diabetes. But caveats apply, caution doctors - Economic Times

Regenerative Therapies Market is Set to Grow at a CAGR of 8.7% by 2033, Propelled by Advancements in  EIN News

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Regenerative Therapies Market is Set to Grow at a CAGR of 8.7% by 2033, Propelled by Advancements in - EIN News

Gene Therapy Market Size (USD 46.5 Bn by 2030): A Growing Industry and Its Impact on Healthcare Systems  EIN News

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Gene Therapy Market Size (USD 46.5 Bn by 2030): A Growing Industry and Its Impact on Healthcare Systems - EIN News

Genetic engineering, also calledgenetic modification, is the direct manipulation of an organismsgenomeusing biotechnology. It is a set of technologies used to change the genetic makeup of cells, including the transfer of genes within and across species boundaries to produce improved or novelorganisms. Read important facts about Genetic Engineering in this article for the IAS Exam.

NewDNAmay be inserted in the host genome by first isolating and copying the genetic material of interest usingmolecular cloningmethods to generate a DNA sequence, or by synthesizing the DNA and then inserting this construct into the host organism.Genesmay be removed, or knocked out, using anuclease.Gene targetingis a different technique that useshomologous recombinationto change an endogenous gene and can be used to delete a gene, removeexons, add a gene, or introducepoint mutations.

Aspirants reading, GEAC can also refer to topics lined below:

Medicine, research, industry and agriculture are a few sectors where genetic engineering applies. It can be used on various plants, animals and microorganisms. The first microorganism to be genetically modified is bacteria.

Genetic Engineering Appraisal Committee (GEAC) is the biotech regulator in India. It is created under the Ministry of Environment and Forests. Read more about GEAC in the linked article.

There are five bodies that are authorized to handle rules noted underEnvironment Protection Act 1986 Rules for Manufacture, Use, Import, Export and Storage of Hazardous Microorganisms/Genetically Engineered Organisms or Cells 1989. These are:

Soybean-Herbicide tolerance,Canola-Altered fatty acid composition,Plum-Virus resistance,Corn-Insect resistance

Pros:Tackling and Defeating Diseases,Getting Rid of All Illnesses in Young and Unborn Children,Potential to Live Longer,Produce New Foods,Faster Growth in Animals and Plants,Pest and Disease Resistance.Cons:May Lead to Genetic Defects,Limits Genetic Diversity,Reduced Nutritional Value,Risky Pathogens,Negative Side Effects

UPSC Preparation:

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Genetic Engineering - Meaning, Applications, Advantages and Challenges ...

Sometimes 15 Minutes Are More Than Enough To Improve Immune System, Sleep Quality And Depression  Revyuh

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Sometimes 15 Minutes Are More Than Enough To Improve Immune System, Sleep Quality And Depression - Revyuh

Where Does Revance Therapeutics Inc (RVNC) Stock Fall in the Biotechnology Field After It Is Lower By -2.17% This Week?  InvestorsObserver

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Where Does Revance Therapeutics Inc (RVNC) Stock Fall in the Biotechnology Field After It Is Lower By -2.17% This Week? - InvestorsObserver

Is TG Therapeutics Inc common stock (TGTX) Stock at the Top of the Biotechnology Industry?  InvestorsObserver

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Is TG Therapeutics Inc common stock (TGTX) Stock at the Top of the Biotechnology Industry? - InvestorsObserver

Where Does GT Biopharma Inc (GTBP) Stock Fall in the Biotechnology Field After It Is Down -20.73% This Week?  InvestorsObserver

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Where Does GT Biopharma Inc (GTBP) Stock Fall in the Biotechnology Field After It Is Down -20.73% This Week? - InvestorsObserver

Where Does Dyne Therapeutics Inc (DYN) Stock Fall in the Biotechnology Field After It Is Lower By -2.35% This Week?  InvestorsObserver

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Where Does Dyne Therapeutics Inc (DYN) Stock Fall in the Biotechnology Field After It Is Lower By -2.35% This Week? - InvestorsObserver

Tampa doctor who lost brother to diabetes calls insulin price cut a 'game changer'  ABC Action News Tampa Bay

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Tampa doctor who lost brother to diabetes calls insulin price cut a 'game changer' - ABC Action News Tampa Bay

Revolutionary Specialty Enzymes Transform Industries, Projected to Reach $2.2 Billion by 2031 - Billion-Dollar  EIN News

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Revolutionary Specialty Enzymes Transform Industries, Projected to Reach $2.2 Billion by 2031 - Billion-Dollar - EIN News

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A Career in Veterinary Medicine - AAVMC

Building the next generation of veterinary professionals (FCL Feb. 22, 2023)  FirstCoastNews.com WTLV-WJXX

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Building the next generation of veterinary professionals (FCL Feb. 22, 2023) - FirstCoastNews.com WTLV-WJXX

Peripheral neuropathy is a disorder of the peripheral nerves. These nerves send messages between the central nervous system, the brain and the spinal cord, and the rest of the body.

Peripheral neuropathy is a general term that describes many conditions caused by damage to the peripheral nervous system, which is responsible for sending sensory information to and from the central nervous system. For example, the peripheral nerves can tell the body when the hands are cold.

Peripheral neuropathy affects more than 20 million people in the United States. In general, the condition can cause a loss of normal nerve signals, or cause inappropriate or distorted signals.

The condition can affect a range of different nerves, so it can impact a variety of locations in different ways. It can affect a single nerve or several nerves at the same time.

Examples of peripheral neuropathy include:

Symptoms of peripheral neuropathy may vary according to the type of neuropathy. Researchers have identified 100 different types of neuropathy.

Generally, the types are classified into three categories, each with its own set of symptoms. They are:

This affects the sensory nerves, which impact the sensations of pain, touch, and temperature.

The person may have:

Especially in cases when the cause is diabetes, sensory neuropathy can also lead to foot and leg ulcers, infection, and gangrene.

This affects the muscles that the brain controls consciously.

Symptoms include:

The affects body processes that the brain controls involuntarily. Symptoms may include:

Treatment either targets the underlying cause, or it aims to provide symptomatic pain relief and prevent further damage. Treatments may include:

Medications that may help relieve symptoms, but do not cure the problem, include:

A persons choice of treatment should take into account any medications that person is taking for other conditions in order to avoid unwanted interactions.

When a persons neuropathy happens as a result of compression of a single nerve, treatment is similar regardless of which nerve is involved. The approach depends on whether the compression is fixed or transient.

A palsy of the ulnar, radial, or peroneal nerve may be temporary and reversible if a person simply avoids the cause of the nerve compression. For example, a person with ulnar nerve palsy should not lean on the affected elbow.

The person may need to rest, use heat, or take a limited course of drugs to reduce inflammation.

In carpal tunnel syndrome, conservative therapy includes splinting the wrist and taking oral or injected corticosteroid drugs.

If a single-nerve neuropathy does not respond to these measures, surgery may be an option in rare cases. Surgery may also be necessary if the nerve compression is fixed, for example when the cause is a tumor.

A doctor should consider referring a person to pain specialist or a relevant clinical specialty at any stage if:

Non-drug measures for peripheral neuropathy can include using warm or cold packs, unless heat or cold makes the symptoms worse.

Stress relief and other complementary therapies include meditation, relaxation techniques, massage, and acupuncture. These may help a person cope with pain from the condition.

Some people find that using a transcutaneous electrical nerve stimulation (TENS) machine helps. This device interrupts nerve messages by delivering a small electric current. Research has not confirmed the effectiveness of this treatment.

Many types of neuropathy are idiopathic, or of unknown cause, but a number of conditions can trigger the problem. These include:

Other causes can include:

Disorders of the small blood vessels can reduce blood supply to the nerves, resulting in nerve tissue damage. Certain benign tumors can also affect nerve tissue and lead to neuropathic pain.

Diabetes is the most common cause of chronic peripheral neuropathy in the U.S. About 60-70 percent of people with diabetes will have some form of damage to their sensory, motor, or autonomic nerves. Many will have foot problems and ulcers.

High blood sugar levels cause damage to the walls of the tiny blood vessels that supply oxygen and nutrients to the nerves in the ends of the hands and feet, and the essential organs in the body, such as the eyes, kidneys, and heart. Whenever skin becomes damaged, the loss of sensation further increases the risk of damage.

Peripheral neuropathy causes a variety of symptoms with many possible causes.

A doctor will usually begin by taking a persons medical history. This includes gathering information about all the symptoms, but also details about a persons life, potential environmental exposures, and any risks of infectious or neurological diseases.

The next step should be a physical and neurological exam that will help the doctor identify any nerve damage. Potential tests a doctor may perform include nerve conduction velocity (NCV) and electromyography (EMG). These tests measure nerve signal strength and electrical activity.

A doctor may also do a nerve biopsy. In cases of suspected autonomic peripheral neuropathy, a person can get a QSART test, which measures their ability to sweat.

For some types of neuropathies, like nerve compression, a person can also get a magnetic resonance imaging (MRI) scan or a computed tomography (CT) scan. Another option is a muscle and nerve ultrasound, but this is not common.

If the doctor confirms that neuropathy is present, the doctor will look for the cause. The doctor may then send the person to get blood tests in order to check for diabetes and other potential underlying conditions.

The doctor may check for vitamin deficiencies, liver or kidney dysfunction, infections, metabolic disorders, or any immune cells that may indicate an immune disorder. In some cases, the doctor may order a test to rule out a genetic disorder.

If none of these tests can point to a cause, a doctor may conduct additional tests.

The outlook for peripheral neuropathy varies depending on the underlying cause, and which nerves have been damaged.

Some cases may improve with time if the underlying cause is treated, but in others, the damage may be permanent or gradually worsen over time.

Peripheral neuropathy describes many different conditions that damage the peripheral nervous system. Many underlying conditions can cause neuropathies, which result in impairments to a persons nerve signals.

A persons symptoms will vary depending on the affected nerves and the type of neuropathy. The condition affects more than 20 million people in the U.S.

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Peripheral neuropathy: Symptoms, causes, and treatment - Medical News Today

Different Types of Peripheral Neuropathy | Paid Content  Local 5 - weareiowa.com

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People produce endocannabinoids similar to compounds found in marijuana that are critical to many bodily functions  The Conversation Indonesia

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People produce endocannabinoids similar to compounds found in marijuana that are critical to many bodily functions - The Conversation Indonesia

Medical condition

Childhood blindness is an important contribution to the national prevalence of the disability of blindness.[3] Blindness in children can be defined as a visual acuity of <3/60 in the eye with better vision of a child under 16 years of age.[4] This generally means that the child cannot see an object 10 feet (about 3 meters) away, that another child could see if it was 200 feet (about 60 meters) away.[5]

There are many causes of blindness in children. Blindness may be due to genetic mutations, birth defects, premature birth, nutritional deficiencies, infections, injuries, and other causes. Severe retinopathy of prematurity (ROP), cataracts, Vitamin A deficiency, measles, conjunctivitis and refractive error are also causes.[6][7]

Vitamin A deficiency is most common in developing countries where many kids experience malnourishment. This vitamin deficiency blinds hundreds of thousands of kids each year, and is a preventable cause of childhood blindness. Since vitamin A is required for rhodopsin, the photosensitive pigment in the retinol rods, its deficiency can lead to night blindness.[8]

Since 2010, globally 85% of children have been vaccinated for measles significantly reducing the number of measles cases each year. Children who have a vitamin A deficiency and measles infection can develop corneal ulcerations and keratomalacia due to immunosuppression caused by the vitamin deficiency.[8]

Newborn conjunctivitis is present at the time of birth and presents within the first 28 days of life as a severe conjunctival infection with purulent discharge. This increases the risk of corneal ulcerations and perforations that can lead to blindness. The common organisms that lead to this diagnosis include Neisseria gonorrhoea and Chlamydia trachomatis. Infected pregnant women and their partners should be treated to avoid infection of the newborn, and newborns presenting with conjunctivitis should be treated with hourly topical antibiotic drops (gentamicin). [8]

Retinopathy of Prematurity (ROP) is classified by the abnormal growth of blood vessels in the retina, a process called retinal neovascularization.[9] These blood vessels may bleed or grow in the wrong direction. Bleeding can lead to the formation of scar tissue which can cause blurred vision and vision loss. If the vessels grow too far in the wrong direction, they can pull the retina away from the back of the eye this is called retinal detachment. Retinal detachment is a medical emergency that can cause permanent blindness and thus requires urgent intervention.[10]

Babies who are born prematurely (formally defined as 37 weeks of gestational age or earlier) are at higher risk of developing retinopathy of prematurity. The earlier a preterm baby is born, the greater the baby's risk of developing ROP. Blood vessels in the eye typically finish development by the time of birth. Therefore, a baby who is born early is exposed to various stimuli (oxygen, lights, temperature, etc.) that may influence how the blood vessels of the eye develop. Additional risk factors for ROP include low birth weight (3 pounds or less) and giving the baby extra oxygen following birth. If preterm infants are experiencing other health problems like anemia, vitamin E deficiency, and/or breathing problems, they are at increased risk of developing ROP.[11]

Childhood blindness has many causes.[12] Leading causes include retinopathy of prematurity, vitamin A deficiency, infectious diseases (measles, newborn conjunctivitis), retinoblastoma, and congenital conditions (cataracts and glaucoma).[13] Leber congenital amaurosis primarily affects the retina, and typically severe visual impairment begins in infancy. Mutations in Aryl hydrocarbon receptor interacting protein like-1 have been linked to Leber congenital amaurosis (LCA).[14]

The most frequently affected parts of the eyes are:[15][16]

The diagnosis of childhood blindness is done via methods to ascertain the degree of visual impairment in the affected child. Early detection is essential to provide early intervention to children. The American Academy of Ophthalmology recommend various screening methods starting in newborns and spanning throughout childhood in order to assess for childhood blindness and other ophthalmic disorders. Newborns are screened with the red reflex test performed by shining a light into the child's eyes. If a red reflex is not produced, further workups should be done to assess for congenital cataracts or retinoblastoma. From 6-12 months, children are screened at their well-child visits with the red reflex test, assessment of eye movement, and proper pupil dilation. From 1 year to 3 years of age, children often undergo a "photoscreening" test where a camera takes pictures of the child's eyes to assess for developmental abnormalities that may lead to amblyopia. Children ages 3 to 5 years of age will be assessed for proper eye alignment and visual acuity. Visual acuity is assessed with a Snellen chart with lines of letters that the child reads and helps determine visual acuity.[17]

The chemical structure of Vitamin A (one of many chemical forms)

Vitamin A deficiency is a leading cause of preventable childhood blindness, particularly in developing countries. Vitamin A deficiency is defined as a serum (blood) concentration of less than 0.70 mol/L while a severe deficiency is defined as less than 0.35 mol/L, per the Centers of Disease Control National Health and Nutrition Examination Survey.[18] Vitamin A is supplied through the diet, and a deficiency often results from poor dietary intake of Vitamin A-rich foods.[19] Low dietary levels of Vitamin A can be worsened by infections that cause inflammation in the gastrointestinal tract, which prevent the body from fully absorbing Vitamin A available within digested food. Children in the United States have a recommended Vitamin A dietary allowance of at least 300 micrograms/day.[19] Good sources of Vitamin A include vegetables, such as carrots, papaya, and pumpkin.[20] Animal products, such as fish oils, as well as dairy products (milk, cheese, and yogurt) are also sources of Vitamin A.[20]

Retinopathy of prematurity (ROP) is a cause of childhood blindness that can occur around the time of birth. Generally, measures taken to avoid preterm birth are also effective at preventing ROP. Babies delivered preterm, defined at or before 37 weeks of gestation, have incomplete development of the blood vessels supplying the retina.[21] At birth, increased exposure to oxygen from the environment and from medical interventions (such as a high flow nasal cannula) causes damage to retinal blood vessels and stunts their growth. Prevention of ROP in preterm babies involves careful monitoring of oxygen delivery to avoid excess exposure.[22] Neonatal ocular exams can help detect ROP.[23]

Whether blindness is treatable depends upon the cause.[24] Surgical intervention can be performed in cases of primary congenital glaucoma. A 2020 review found no difference between combined trabeculotomy and trabeculectomy (CTT) and routine conventional trabeculotomy, or between viscotrabeculotomy and routine conventional trabeculotomy. The review also found that the 360-degree circumferential trabeculotomy may show greater surgical success than conventional trabeculotomy but that further research with one year follow-up was needed.[25]

Braille is a universal way to learn how to read and write, for the blind.[26] A refreshable braille display is an assistive learning device that can help such children in school.[27] Schools for the blind are a form of management, however the limitations of using studies done in such schools has been recognized. Children that are enrolled presently usually developed blindness 5 or more years prior to enrollment, consequently not reflecting current possible causes.[28] About 66% of children with visual impairment also have one other disability (comorbidity), be it, intellectual disabilities, cerebral palsy, or hearing loss.[29] Eye care/screening for children within primary health care is important, as catching ocular disease issues can lead to better outcomes overall.[30]

Globally, the number children with blindness is approximately 1.4 million, representing 4% of the global blind population, and an additional 17.5 million are at risk of developing poor vision.[31] Although this number is significantly lower than the number of blind adults, the estimated economic and social burden of blindness for children is much greater due to the increase in blind years. Childhood blindness is most prevalent among children with genetic ancestry from Africa and Asia, who represent 75% of the world's affected population.[13][32] A 2014 review indicated that an estimated 238,500 children with bilateral blindness (rate 1.2/1,000) live in the Eastern Mediterranean region.[30] There is also an increase in blindness outside of developing countries due to a lack of screening and prophylactic measures to treat causes of pediatric blindness.[33]

VISION 2020 is a program launched by the International Agency for the Prevention of Blindness (IAPB) and is supported by the WHO in 1999 that has made controlling blindness in children a high priority.[34] In addition, the IAPB and WHO coordinate "World Sight Day" on the second Thursday of October each year.[35] Starting in 2000, World Sight Day has become an opportunity to raise awareness of eye health and highlight the importance of increasing access to eye health services globally. It has also become a tool to influence governments around the world to allocate funds for blindness prevention programs and educational initiatives.

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Childhood blindness - Wikipedia

FDA Approves Syfovre (pegcetacoplan injection) for the Treatment of Geographic Atrophy, a Leading Cause of Blindness

WALTHAM, Mass., Feb. 17, 2023 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in complement, today announced that the U.S. Food and Drug Administration (FDA) has approved Syfovre (pegcetacoplan injection) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). Syfovre is the first and only FDA-approved treatment for GA, a leading cause of blindness that impacts more than one million people in the U.S. and five million people worldwide.1,2

The approval of Syfovre is the most important event in retinal ophthalmology in more than a decade, said Eleonora Lad, M.D., Ph.D., lead investigator for the OAKS study, director of ophthalmology clinical research, associate professor of ophthalmology, Duke University Medical Center. Until now, there have been no approved therapies to offer people living with GA as their vision relentlessly declined. With Syfovre, we finally have a safe and effective GA treatment for this devastating disease, with increasing effects over time.

Today marks an extraordinary milestone for patients, the retina community, and Apellis. With its increasing effects over time and flexible dosing, we believe that Syfovre will make a meaningful difference in the lives of people with GA, said Cedric Francois, M.D., Ph.D., co-founder and chief executive officer, Apellis. GA is a complex disease that the field has spent decades trying to address, so we are humbled and proud to bring forward the first-ever treatment. Thank you to all who helped make this moment a reality.

The approval of Syfovre is based on positive results from the Phase 3 OAKS and DERBY studies at 24 months across a broad and representative population of patients. Syfovre is approved for GA patients with or without subfoveal involvement and provides dosing flexibility for patients and physicians with a dosing regimen of every 25 to 60 days. In the OAKS and DERBY studies, Syfovre reduced the rate of GA lesion growth compared to sham and demonstrated increasing treatment effects over time, with the greatest benefit (up to 36% reduction in lesion growth with monthly treatment in DERBY) occurring between months 18-24.

For the first time ever, we are celebrating the approval of a treatment for GA, said Jeff Todd, president and chief executive officer, Prevent Blindness. This is a historic and hopeful day for all GA patients and their care partners, who have been waiting for a treatment for this relentless form of vision loss.

GA is an advanced form of AMD. It is a progressive and irreversible disease caused by the growth of lesions, which destroy the retinal cells responsible for vision. The vision loss caused by GA severely impairs independence and quality of life by making it difficult to participate in daily activities. On average, it takes only 2.5 years for GA lesions to start impacting the fovea, which is responsible for central vision.3

The safety profile of Syfovre is well-demonstrated following ~12,000 injections. The most common adverse reactions ( 5%) reported in patients receiving Syfovre were ocular discomfort, neovascular AMD, vitreous floaters, and conjunctival hemorrhage.

Apellis is committed to helping patients with treatment access and support. ApellisAssist is a program designed to help Syfovre patients along their treatment journey by providing a system inclusive of insurance support, financial assistance for eligible patients, disease education, and ongoing product support. Patients and healthcare providers can call 1-888-273-5547 for more information.

Syfovre is expected to be available by the beginning of March through specialty distributors and specialty pharmacies nationwide. A marketing authorization application for Syfovre is under review by the European Medicines Agency with a decision expected in early 2024. In addition, a marketing application has been submitted to Health Canada.

About the Phase 3 OAKS and DERBY StudiesOAKS (n=637) and DERBY (n=621) are Phase 3, multicenter, randomized, double-masked, sham-controlled studies comparing the efficacy and safety of Syfovre (pegcetacoplan injection) with sham injections across a broad and representative population of patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The studies evaluated the efficacy of monthly and every-other-month Syfovre in patients with GA assessed by change in the total area of GA lesions from baseline as measured by fundus autofluorescence at 24 months.

Both monthly and every-other-month (EOM) Syfovre reduced the rate of GA lesion growth through 24 months compared to sham:

About Syfovre (pegcetacoplan injection) Syfovre (pegcetacoplan injection) is the first and only approved therapy for geographic atrophy (GA). By targeting C3, Syfovre is designed to provide comprehensive control of the complement cascade, part of the bodys immune system. Syfovre is approved in the United States for the treatment of GA secondary to age-related macular degeneration.

U.S. Important Safety Information for Syfovre (pegcetacoplan injection)

CONTRAINDICATIONS

WARNINGS AND PRECAUTIONS

ADVERSE REACTIONS

About Apellis Apellis Pharmaceuticals, Inc. is a global biopharmaceutical company that combines courageous science and compassion to develop life-changing therapies for some of the most challenging diseases patients face. We ushered in the first new class of complement medicine in 15 years and now have two approved medicines targeting C3. These include the first and only therapy for geographic atrophy, a leading cause of blindness around the world. With nearly a dozen clinical and pre-clinical programs underway, we believe we have only begun to unlock the potential of targeting C3 across many serious diseases. For more information, please visit http://apellis.com or follow us on Twitter and LinkedIn.

Apellis Forward-Looking Statement Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements regarding timing of the commercial availability of Syfovre. The words anticipate, believe, continue, could, estimate, expect, intend, may, plan, potential, predict, project, should, target, will, would and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including whether Syfovre will be commercially available when expected; whether clinical trials of Syfovre indicate an apparent positive effect that is greater than the actual positive effect, whether Syfovre will receive approval from foreign regulatory agencies for GA when expected or at all; and other factors discussed in the Risk Factors section of Apellis Annual Report on Form 10-K with the Securities and Exchange Commission on February 28, 2022 and the risks described in other filings that Apellis may make with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Apellis specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

1 Rudnicka AR, Jarrar Z, Wormald R, et al. Age and gender variations in age-related macular degeneration prevalence in populations of European ancestry: a meta analysis. Ophthalmology 2012;119:571580.2 Wong WL, Su X, Li X, et al. Global prevalence of age-related macular degeneration and disease burden projection for 2020 and 2040: a systematic review and meta-analysis. Lancet Glob Health 2014;2:e106116.3 Lindblad AS, et al, and AREDS Research Group. Arch Ophthalmol. 2009;127(9):1168-1174.

Posted: February 2023

Syfovre (pegcetacoplan) FDA Approval History

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FDA Approves Syfovre (pegcetacoplan injection) for the Treatment of ...

Fasting may help improve immune system; 3 reasons why one should fast at least once a week or a month  Times Now

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Fasting may help improve immune system; 3 reasons why one should fast at least once a week or a month - Times Now