Age-Related
`Macular Degeneration
`What You Should Know
`
`U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
`National Institutes of Health
`National Eye Institute
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`Mylan Exhibit 1042
`Mylan v. Regeneron, IPR2021-00881
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`Macular Degeneration
`What You Should Know
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`U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
`National Institutes of Health
`National Eye Institute
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`Mylan Exhibit 1042
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`The National Eye Institute (NEI) conducts and supports
`research that leads to sight-saving treatments and plays a
`key role in reducing visual impairment and blindness. NEI is
`part of the National Institutes of Health, an agency of the
`U.S. Department of Health and Human Services.
`
`For more information, contact—
`National Eye Institute
`National Institutes of Health
`2020 Vision Place
`Bethesda, MD 20892–3655
`Telephone: 301–496–5248
`Email: 2020@nei.nih.gov
`Website: www.nei.nih.gov
`
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`About AMD
`
`Detection
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`Stages of AMD
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`Treatment
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`What You Can Do
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`Current Research
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`Additional Resources
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`Contents
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`What is AMD?
`
`AMD is a common eye condition and a leading cause
`of vision loss among people age 60 and older. It causes
`damage to the macula, a small spot near the center of the
`retina and the part of the eye needed for sharp, central
`vision, which lets us see objects that are straight ahead.
`
`In some people, AMD advances so slowly that vision loss
`does not occur for a long time. In others, the disease
`progresses faster and may lead to a loss of vision in one
`or both eyes. As AMD progresses, a blurred area near the
`center of vision is a common symptom. Over time, the
`blurred area may grow larger or you may develop blank
`spots in your central vision. Objects also may not appear to
`be as bright as they used to be.
`
`AMD by itself does not lead to complete blindness, with no
`ability to see. However, the loss of central vision in AMD
`can interfere with simple everyday activities, such as the
`ability to see faces, drive, read, write, or do close work, such
`as cooking or fixing things around the house.
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`About AMD
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`Vitreous gel
`
`Retina
`
`Macula
`
`Optic
`nerve
`
`The macula
`
`Cornea
`Pupil
`Lens
`
`The macula is made
`up of millions of
`light-sensing cells
`that provide sharp,
`central vision. It is
`the most sensitive
`part of the retina,
`which is located
`at the back of the eye. The retina turns light into
`electrical signals and then sends these electrical signals
`through the optic nerve to the brain, where they are
`translated into the images we see. When the macula is
`damaged, the center of your field of view may appear
`blurry, distorted, or dark.
`
`Who is at risk?
`
`Age is a major risk factor for AMD. The disease is most likely
`to occur after age 60, but it can occur earlier. Other risk
`factors for AMD include:
`• Smoking. Research shows that smoking doubles the risk
`of AMD.
`
`• Race. AMD is more common among Caucasians than
`among African-Americans or Hispanics/Latinos.
`
`• Family history and genetics. People with a family history
`of AMD are at higher risk. At last count, researchers had
`identified nearly 20 genes that can affect the risk of developing
`AMD. Many more genetic risk factors are suspected.
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` You may see offers for genetic testing for AMD. Because
`AMD is influenced by so many genes, plus environmental
`factors such as smoking and nutrition, there are currently
`no genetic tests that can diagnose AMD, or predict with
`certainty who will develop it.
`
`The American Academy of Ophthalmology currently
`recommends against routine genetic testing for AMD,
`and insurance generally does not cover such testing.
`
`Does lifestyle make a difference?
`
`Researchers have found links between AMD and some
`lifestyle choices, such as smoking. You might be able
`to reduce your risk of AMD or slow its progression by
`making these healthy choices:
`
`• Avoid smoking
`• Exercise regularly
`• Maintain normal blood pressure and
`cholesterol levels
`• Eat a healthy diet rich in green, leafy
`vegetables and fish
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`About AMD
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`How is AMD detected?
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`The early and intermediate stages of AMD usually start
`without symptoms. Only a comprehensive dilated eye exam
`can detect AMD. The eye exam may include the following:
`
`• Visual acuity test. This eye chart measures how well you
`see at distances.
`
`• Dilated eye exam. Your eye care professional places drops
`in your eyes to widen or dilate the pupils. This provides
`a better view of the back of your eye. Using a special
`magnifying lens, he or she then looks at your retina and
`optic nerve for signs of AMD and other eye problems.
`
`• Amsler grid. Your eye care professional also may ask you
`to look at an Amsler grid. Changes in your central vision
`may cause the lines in the grid to disappear or appear
`wavy, a sign of AMD.
`
`Here is what an Amsler grid
`normally looks like.
`
`This is what an Amsler grid
`might look like to someone
`with AMD.
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`• Fluorescein angiogram. In this test, which is performed
`by an ophthalmologist, a fluorescent dye is injected into
`your arm. Pictures are taken as the dye passes through
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`Detection
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`the blood vessels in your eye. This makes it possible to
`see leaking blood vessels, which occur in a severe, rapidly
`progressive type of AMD (see page 8). In rare cases,
`complications to the injection can arise, from nausea to
`more severe allergic reactions.
`
`• Optical coherence tomography. You have probably heard
`of ultrasound, which uses sound waves to capture images
`of living tissues. OCT is similar except that it uses light
`waves, and can achieve very high-resolution images of
`any tissues that can be penetrated by light—such as the
`eyes. After your eyes are dilated, you’ll be asked to place
`your head on a chin rest and hold still for several seconds
`while the images are obtained. The light beam is painless.
`
`During the exam, your eye care professional will look for
`drusen, which are yellow deposits beneath the retina.
`Most people develop some very small drusen as a normal
`part of aging. The presence of medium-to-large drusen
`may indicate that you have AMD.
`
`Another sign of AMD is the appearance of pigmentary
`changes under the retina. In addition to the pigmented cells
`in the iris (the colored part of the eye), there are pigmented
`cells beneath the retina. As these cells break down and
`release their pigment, your eye care professional may see
`dark clumps of released pigment and later, areas that are
`less pigmented. These changes will not affect your eye color.
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`Questions to ask your eye care
`professional
`
`Below are a few questions you may want to ask your
`eye care professional to help you understand your
`diagnosis and treatment. If you do not understand
`your eye care professional’s responses, ask questions
`until you do understand.
`
`• What is my diagnosis and how do you spell the name
`of the condition?
`• Can my AMD be treated?
`• How will this condition affect my vision now and in the
`future?
`• What symptoms should I watch for and how should I
`notify you if they occur?
`• Should I make lifestyle changes?
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`Stages of AMD
`
`What are the stages of AMD?
`
`There are three stages of AMD defined in part by the size
`and number of drusen under the retina. It is possible to
`have AMD in one eye only, or to have one eye with a later
`stage of AMD than the other.
`
`• Early AMD. Early AMD is diagnosed by the presence of
`medium-sized drusen, which are about the width of an
`average human hair. People with early AMD typically do
`not have vision loss.
`
`• Intermediate AMD. People with intermediate AMD
`typically have large drusen, pigment changes in the
`retina, or both. Again, these changes can only be
`detected during an eye exam. Intermediate AMD
`may cause some vision loss, but most people will not
`experience any symptoms.
`
`• Late AMD. In addition to drusen, people with late AMD
`have vision loss from damage to the macula. There are
`two types of late AMD:
`
`• In geographic atrophy (also called dry AMD), there is
`a gradual breakdown of the light-sensitive cells in the
`macula that convey visual information to the brain,
`and of the supporting tissue beneath the macula.
`These changes cause vision loss.
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`• In neovascular AMD (also called wet AMD),
`abnormal blood vessels grow underneath the retina.
`(“Neovascular” literally means “new vessels.”) These
`vessels can leak fluid and blood, which may lead to
`swelling and damage of the macula. The damage may
`be rapid and severe, unlike the more gradual course
`of geographic atrophy. It is possible to have both
`geographic atrophy and neovascular AMD in the same
`eye, and either condition can appear first.
`
`AMD has few symptoms in the early stages, so it is important
`to have your eyes examined regularly. If you are at risk for AMD
`because of age, family history, lifestyle, or some combination
`of these factors, you should not wait to experience changes
`in vision before getting checked for AMD.
`
`Not everyone with early AMD will develop late AMD. For
`people who have early AMD in one eye and no signs of
`AMD in the other eye, about five percent will develop
`advanced AMD after 10 years. For people who have early
`AMD in both eyes, about 14 percent will develop late AMD
`in at least one eye after 10 years. With prompt detection of
`AMD, there are steps you can take to further reduce your
`risk of vision loss from late AMD.
`
`If you have late AMD in one eye only, you may not notice
`any changes in your overall vision. With the other eye seeing
`clearly, you may still be able to drive, read, and see fine
`details. However, having late AMD in one eye means you are
`at increased risk for late AMD in your other eye. If you notice
`distortion or blurred vision, even if it doesn’t have much
`effect on your daily life, consult an eye care professional.
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`Treatment
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`How is AMD treated?
`
`Early AMD
`
`Currently, no treatment exists for early AMD, which in many
`people shows no symptoms or loss of vision. Your eye care
`professional may recommend that you get a comprehensive
`dilated eye exam at least once a year. The exam will help
`determine if your condition is advancing.
`
`As for prevention, AMD occurs less often in people who
`exercise, avoid smoking, and eat nutritious foods including
`green leafy vegetables and fish. If you already have AMD,
`adopting some of these habits may help you keep your
`vision longer.
`
`Intermediate and late AMD
`
`Researchers at the National Eye Institute tested whether
`taking nutritional supplements could protect against
`AMD in the Age-Related Eye Disease Studies (AREDS and
`AREDS2). They found that daily intake of certain high-dose
`vitamins and minerals can slow progression of the disease in
`people who have intermediate AMD, and those who have
`late AMD in one eye.
`
`The first AREDS trial showed that a combination of vitamin
`C, vitamin E, beta-carotene, zinc, and copper can reduce
`the risk of late AMD by 25 percent. The AREDS2 trial tested
`whether this formulation could be improved by adding
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`lutein, zeaxanthin or omega-3 fatty acids. Omega-3 fatty
`acids are nutrients enriched in fish oils. Lutein, zeaxanthin
`and beta-carotene all belong to the same family of
`vitamins, and are abundant in green leafy vegetables.
`
`The AREDS2 trial found that adding lutein and zeaxanthin
`or omega-3 fatty acids to the original AREDS formulation
`(with beta-carotene) had no overall effect on the risk of late
`AMD. However, the trial also found that replacing beta-
`carotene with a 5-to-1 mixture of lutein and zeaxanthin
`may help further reduce the risk of late AMD. Moreover,
`while beta-carotene has been linked to an increased risk
`of lung cancer in current and former smokers, lutein and
`zeaxanthin appear to be safe regardless of smoking status.
`
`Here are the clinically effective doses tested in AREDS and
`AREDS2:
`
`• 500 milligrams (mg) of vitamin C
`
`• 400 international units of vitamin E
`
`• 80 mg zinc as zinc oxide (25 mg in AREDS2)
`
`• 2 mg copper as cupric oxide
`
`• 15 mg beta-carotene, OR 10 mg lutein and 2 mg
`zeaxanthin
`A number of manufacturers offer nutritional supplements
`that were formulated based on these studies. The label may
`refer to “AREDS” or “AREDS2.”
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`Treatment
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`If you have intermediate or late AMD, you might benefit
`from taking such supplements. But first, be sure to review
`and compare the labels. Many of the supplements have
`different ingredients, or different doses, from those tested
`in the AREDS trials. Also, consult your doctor or eye care
`professional about which supplement, if any, is right for
`you. For example, if you smoke regularly, or used to,
`your doctor may recommend that you avoid supplements
`containing beta-carotene.
`
`Even if you take a daily multivitamin, you should consider
`taking an AREDS supplement if you are at risk for late AMD.
`The formulations tested in the AREDS trials contain much
`higher doses of vitamins and minerals than what is found
`in multivitamins. Tell your doctor or eye care professional
`about any multivitamins you are taking when you are
`discussing possible AREDS formulations.
`
`You may see claims that your specific genetic makeup
`(genotype) can influence how you will respond to AREDS
`supplements. Some recent studies have claimed that,
`depending on genotype, some patients will benefit from
`AREDS supplements and others could be harmed. These
`claims are based on a portion of data from the AREDS
`research. NEI investigators have done comprehensive
`analyses of the complete AREDS data. Their findings to date
`indicate that AREDS supplements are beneficial for patients
`of all tested genotypes. Based on the overall data, the
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`American Academy of Ophthalmology does not support the
`use of genetic testing to guide treatment for AMD.
`
`Finally, remember that the AREDS formulation is not a
`cure. It does not help people with early AMD, and will
`not restore vision already lost from AMD. But it may delay
`the onset of late AMD. It also may help slow vision loss in
`people who already have late AMD.
`
`Advanced neovascular AMD
`
`Neovascular AMD typically results in severe vision loss.
`However, eye care professionals can try different therapies
`to stop further vision loss. You should remember that the
`therapies described below are not a cure. The condition
`may progress even with treatment.
`
`• Injections. One option to slow the progression of
`neovascular AMD is to inject drugs into the eye. With
`neovascular AMD, abnormally high levels of vascular
`endothelial growth factor (VEGF) are secreted in your
`eyes. VEGF is a protein that promotes the growth of new
`abnormal blood vessels. Anti-VEGF injection therapy
`blocks this growth. If you get this treatment, you may
`need multiple monthly injections. Before each injection,
`your eye will be numbed and cleaned with antiseptics.
`To further reduce the risk of infection, you may be
`prescribed antibiotic drops. A few different anti-VEGF
`drugs are available. They vary in cost and in how often
`they need to be injected, so you may wish to discuss these
`issues with your eye care professional.
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`Treatment
`
`• Photodynamic therapy. This technique involves laser
`treatment of select areas of the retina. First, a drug called
`verteporfin will be injected into a vein in your arm. The
`drug travels through the blood vessels in your body, and
`is absorbed by new, growing blood vessels. Your eye care
`professional then shines a laser beam into your eye to
`activate the drug in the new abnormal blood vessels, while
`sparing normal ones. Once activated, the drug closes off
`the new blood vessels, slows their growth, and slows the
`rate of vision loss. This procedure is less common than anti-
`VEGF injections, and is often used in combination with
`them for specific types of neovascular AMD.
`
`• Laser surgery. Eye care professionals treat certain cases
`of neovascular AMD with laser surgery, though this is less
`common than other treatments. It involves aiming an
`intense “hot” laser at the abnormal blood vessels in your
`eyes to destroy them. This laser is not the same one used
`in photodynamic therapy which may be referred to as a
`“cold” laser. This treatment is more likely to be used when
`blood vessel growth is limited to a compact area in your
`eye, away from the center of the macula, that can be easily
`targeted with the laser. Even so, laser treatment also may
`destroy some surrounding healthy tissue. This often results
`in a small blind spot where the laser has scarred the retina.
`In some cases, vision immediately after the surgery may be
`worse than it was before. But the surgery may also help
`prevent more severe vision loss from occurring years later.
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`Questions to ask your eye care
`professional about treatment
`
`• What is the treatment for advanced
`neovascular AMD?
`• When will treatment start and how long will it
`last?
`• What are the benefits of this treatment and
`how successful is it?
`• What are the risks and side effects associated
`with this treatment and how has this
`information been gathered?
`• Should I avoid certain foods, drugs, or activities
`while I am undergoing treatment?
`• Are other treatments available?
`• When should I follow up after treatment?
`
`How can I cope with vision loss?
`
`Coping with AMD and vision loss can be a traumatic
`experience. This is especially true if you have just begun to lose
`your vision or have low vision. Having low vision means that
`even with regular glasses, contact lenses, medicine, or surgery,
`you find everyday tasks difficult to do. Reading the mail,
`shopping, cooking, and writing can all seem challenging.
`
`However, help is available. You may not be able to restore
`your vision, but low vision services can help you make the
`most of what is remaining. You can continue enjoying
`friends, family, hobbies, and other interests just as you
`always have. The key is to not delay use of these services.
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`What You Can Do
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`What is vision rehabilitation?
`
`To cope with vision loss, you must first have an excellent
`support team. This team should include you, your primary
`eye care professional, and an optometrist or ophthalmologist
`specializing in low vision. Occupational therapists, orientation
`and mobility specialists, certified low vision therapists,
`counselors, and social workers are also available to help.
`Together, the low vision team can help you make the most
`of your remaining vision and maintain your independence.
`
`Second, talk with your eye care professional about your
`vision problems. Ask about vision rehabilitation, even if
`your eye care professional says that “nothing more can be
`done for your vision.” Vision rehabilitation programs offer
`a wide range of services, including training for magnifying
`and adaptive devices, ways to complete daily living skills
`safely and independently, guidance on modifying your
`home, and information on where to locate resources and
`support to help you cope with your vision loss.
`
`Medicare may cover part or all of a patient’s occupational
`therapy, but the therapy must be ordered by a doctor and
`provided by a Medicare-approved healthcare provider. To
`see if you are eligible for Medicare-funded occupational
`therapy, call 1–800–MEDICARE or 1–800–633–4227.
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`Where can I go for services?
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`Low vision services can take place in different locations,
`including:
`
`• Ophthalmology or optometry offices that specialize in
`low vision
`
`• Hospital clinics
`
`• State, nonprofit, or for-profit vision rehabilitation
`organizations
`
`• Independent-living centers
`What are some low vision devices?
`
`Because low vision varies from person to person, specialists
`have different tools to help patients deal with vision loss.
`They include:
`
`• Reading glasses with high-powered lenses
`
`• Handheld magnifiers
`
`• Video magnifiers
`
`• Computers with large-print and speech-output systems
`
`• Large-print reading materials
`
`• Talking watches, clocks, and calculators
`
`• Computer aids and other technologies, such as a closed-
`circuit television, which uses a camera and television to
`enlarge printed text
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`What You Can Do
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`For some patients with end-stage AMD, an Implantable
`Miniature Telescope (IMT) may be an option. This FDA-
`approved device can help restore some lost vision by
`refocusing images onto a healthier part of the retina. After
`the surgery to implant the IMT, patients participate in an
`extensive vision rehabilitation program.
`
`Keep in mind that low vision aids without proper diagnosis,
`evaluation, and training may not work for you. It is
`important that you work closely with your low vision
`team to get the best device or combination of aids to help
`improve your ability to see.
`
`Questions to ask your eye care
`professional about low vision
`
`• How can I continue my normal, routine
`activities?
`• Are there resources to help me?
`• Will any special devices help me with reading,
`cooking, or fixing things around the house?
`• What training is available to me?
`• Where can I find individual or group support to
`cope with my vision loss?
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`What is Charles Bonnet syndrome (visual hallucinations)?
`
`People with impaired vision sometimes see things that are
`not there, called visual hallucinations. They may see simple
`patterns of colors or shapes, or detailed pictures of people,
`animals, buildings, or landscapes. Sometimes these images
`fit logically into a visual scene, but they often do not.
`
`This condition can be alarming, but don’t worry—it is not a
`sign of mental illness. It is called Charles Bonnet syndrome,
`and it is similar to what happens to some people who have
`lost an arm or leg. Even though the limb is gone, these
`people still feel their toes or fingers or experience itching.
`Similarly, when the brain loses input from the eyes, it may
`fill the void by generating visual images on its own.
`
`Charles Bonnet syndrome is a common side effect of vision
`loss in people with AMD. However, it often goes away a
`year to 18 months after it begins. In the meantime, there
`are things you can do to reduce hallucinations. Many
`people find the hallucinations occur more frequently in
`evening or dim light. Turning on a light or television may
`help. It may also help to blink, close your eyes, or focus on a
`real object for a few moments.
`
`How can I cope with AMD?
`
`AMD and vision loss can profoundly affect your life. This is
`especially true if you lose your vision rapidly.
`
`Even if you experience gradual vision loss, you may not be
`able to live your life the way you used to. You may need
`to cut back on working, volunteering, and recreational
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`What You Can Do
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`activities. Your relationships may change, and you may
`need more help from family and friends than you are used
`to. These changes can lead to feelings of loss, lowered self-
`esteem, isolation, and depression.
`
`In addition to getting medical treatment for AMD, there
`are things you can do to cope:
`
`• Learn more about your vision loss.
`
`• Visit a specialist in low vision and get devices and learning
`skills to help you with the tasks of everyday living.
`
`• Try to stay positive. People who remain hopeful say they
`are better able to cope with AMD and vision loss.
`
`• Stay engaged with family and friends.
`
`• Seek a professional counselor or support group. Your
`doctor or eye care professional may be able to refer you
`to one.
`What information can I share with family members?
`
`Shock, disbelief, depression, and anger are common
`reactions among people who are diagnosed with AMD.
`These feelings can subside after a few days or weeks,
`or they may last longer. This can be upsetting to family
`members and caregivers who are trying to be as caring and
`supportive as possible.
`
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`Mylan v. Regeneron, IPR2021-00881
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`Following are some ideas family members might consider:
`
`• Obtain as much information as possible about AMD and
`how it affects sight. Share the information with the
`person who has AMD.
`
`• Find support groups and other resources within the
`community.
`
`• Encourage family and friends to visit and support the
`person with AMD.
`
`• Allow for grieving. This is a natural process.
`
`• Lend support by “being there.”
`
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`Mylan v. Regeneron, IPR2021-00881
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`Current Research
`
`What research is being done?
`
`NEI conducts and supports research in labs and clinical centers
`across the country to better prevent, detect, and treat AMD.
`
`NEI-funded research over the past decade has revealed new
`insight into the genetics of AMD. By screening the DNA
`of thousands of people with and without AMD, scientists
`have identified differences in genes that affect AMD risk.
`Armed with this knowledge, researchers are identifying
`key biochemical pathways involved in the disease and are
`exploring therapies that could interrupt these pathways. It
`might also be possible to develop drug therapies for AMD
`that are targeted specifically to a person’s unique genetic
`risk factors.
`
`Scientists are also exploring ways to regenerate tissues
`destroyed by AMD. One approach is to make stem cells
`from a patient’s own skin or blood. In a lab, these stem cells
`can be specially treated to form sheets of retinal pigment
`epithelium (RPE)—the pigmented layer of tissue that
`supports the light-sensitive cells of the retina. The goal is
`to generate layers of RPE that can be implanted into the
`patient’s eye to preserve vision.
`
`The NEI Audacious Goals Initiative (AGI) is taking on one
`of the biggest challenges in medicine: the regeneration of
`nerve cells in the retina and brain. In humans, once brain
`and retinal neurons are gone—due to injury or diseases like
`AMD—they are typically gone for good. However, lessons
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`from nature suggest that it may possible to overcome this
`limitation. For example, in some fish and amphibians, if
`the retina is damaged, it can grow back. Through targeted
`research, the NEI AGI aims to unlock these secrets and
`utilize them in humans—to develop new therapies to
`regenerate neurons and neural connections in the eye and
`visual system.
`
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`Additional Resources
`
`Where can I get more information?
`
`For more information about age-related macular
`degeneration, you may wish to contact:
`
`American Academy of Ophthalmology
`P.O. Box 7424
`San Francisco, CA 94120–7424
`415–561–8500
`www.aao.org
`www.eyecareamerica.org (Online Referral)
`
`American Foundation for the Blind
`2 Penn Plaza, Suite 1102
`New York, NY 10121
`1–800–232–5463
`212–502–7600
`Email: afbinfo@afb.net
`www.afb.org
`
`American Optometric Association
`243 North Lindbergh Boulevard, Floor 1
`St. Louis, MO 63141–7851
`314–991–4100
`1-800-365-2219
`www.aoa.org
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`Association for Macular Diseases
`210 East 64th Street, #8
`New York, NY 10065
`212–605–3719
`http://macula.org
`
`Council of Citizens with Low Vision International
`2200 Wilson Blvd. Suite 650
`Arlington, VA 22201
`1–800–733–2258
`Email: president@cclvi.org
`www.cclvi.org
`
`The Foundation Fighting Blindness
`7168 Columbia Gateway Drive, Suite 100
`Columbia, MD 21046
`1–800-683-5555
`410-423-0600
`Email: info@fightblindness.org
`www.fightblindness.org
`
`Macular Degeneration Partnership
`6222 Wilshire Blvd., Suite 260
`Los Angeles, CA 90048
`1–888–430–9898
`310–423–6455
`www.amd.org
`
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`Additional Resources
`
`National Eye Institute
`National Institutes of Health
`2020 Vision Place
`Bethesda, MD 20892–3655
`301–496–5248
`Email: 2020@nei.nih.gov
`www.nei.nih.gov
`
`Prevent Blindness
`211 West Wacker Drive, Suite 1700
`Chicago, IL 60606
`1–800–331–2020
`Email: info@preventblindness.org
`www.preventblindness.org
`
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`NotesNotes
`
`
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`U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
`National Institutes of Health
`National Eye Institute
`Revised 9/15
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