iT
`
`
`@)
`
`Samsung Bioepis Exhibit 1027 - Page 1
`Biocon Exhibit 1027 - Page 1
`
`
`
`
`@)
`
`Samsung Bioepis Exhibit 1027 - Page 1
`Biocon Exhibit 1027 - Page 1
`
`
`
`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
`
`Samsung Bioepis Exhibit 1027 - Page 2
`Biocon Exhibit 1027 - Page 2
`
`
`
`About AMD
`
`Detection
`
`Stages of AMD
`
`Treatment
`
`What You Can Do
`
`Current Research
`
`
`
`
`
`
`
`
`
`
`Additional Resources
`
`4
`
`7
`
`9
`
`14
`
`21
`
`23
`
`SamsungBioepis Exhibit 1027 - Page 3
`Biocon Exhibit 1027 - Page 3
`
`
`
`Samsung Bioepis Exhibit 1027 - Page 4
`Biocon Exhibit 1027 - Page 4
`
`
`
`About AMD
`
`Whatis 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.
`
`as cooking or fixing things around the house.
`
`In some people, AMD advancesso slowly that vision loss
`does not occur for a long time. In others, the disease
`progresses faster and maylead toa 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 byitself 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
`
`SamsungBioepis Exhibit 1027 - Page 5
`Biocon Exhibit 1027 - Page 5
`
`
`
`
`
`The macula
`
`blurry, distorted, or dark.
`
`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
`
`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.
`
`e Race. AMD is more common among Caucasians than
`among African-Americans or Hispanics/Latinos.
`
`e Family history and genetics. People with a family history
`of AMD areat higher risk. At last count, researchers had
`identified nearly 20 genes that can affect the risk of developing
`AMD. Many moregenetic risk factors are suspected.
`
`SamsungBioepis Exhibit 1027 - Page 6
`Biocon Exhibit 1027 - Page 6
`
`
`
`About AMD
`
`The American Academy of Ophthalmology currently
`recommends against routine genetic testing for AMD,
`and insurance generally does not cover suchtesting.
`
`Doeslifestyle 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:
`
`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.
`
`vegetables and fish
`
`Avoid smoking
`Exercise regularly
`Maintain normal blood pressure and
`cholesterol levels
`
`Eat a healthy diet rich in green, leafy
`
`SamsungBioepis Exhibit 1027 - Page 7
`Biocon Exhibit 1027 - Page 7
`
`
`
`How is AMD detected?
`
`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.
`
`4
`
`• 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
`
`Samsung Bioepis Exhibit 1027 - Page 8
`Biocon Exhibit 1027 - Page 8
`
`
`
`tsoe,
`
`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
`moresevere allergic reactions.
`
`¢ Optical coherence tomography. You have probably heard
`of ultrasound, which uses sound wavesto 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 changeswill not affect your eye color.
`
`SamsungBioepis Exhibit 1027 - Page 9
`Biocon Exhibit 1027 - Page 9
`
`
`
`Questions to ask your eye care
`professional
`
`e¢ Whatis my diagnosis and how do you spell the name
`of the condition?
`
`¢ Can my AMD betreated?
`¢ How will this condition affect my vision now and in the
`future?
`
`Below are a few questions you may wantto 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.
`
`¢ Should | makelifestyle changes?
`
`e¢ What symptoms should | watch for and how should |
`notify you if they occur?
`
`SamsungBioepis Exhibit 1027 - Page 10
`Biocon Exhibit 1027 - Page 10
`
`
`
`Stages of AMD
`
`Whatare 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 oneeye only, or to have one eye with a later
`stage of AMD than the other.
`
`e 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 havevision loss.
`
`e Intermediate AMD. People with intermediate AMD
`typically have large drusen, pigment changesin 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.
`
`e 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:
`
`e
`
`In geographic atrophy (also called dry AMD), thereis
`a gradual breakdown ofthe light-sensitive cells in the
`macula that convey visual information to the brain,
`and of the supporting tissue beneath the macula.
`These changescause vision loss.
`
`
`
`SamsungBioepis Exhibit 1027 - Page 11
`Biocon Exhibit 1027 - Page 11
`
`
`
`• 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.
`
`8
`
`Samsung Bioepis Exhibit 1027 - Page 12
`Biocon Exhibit 1027 - Page 12
`
`
`
`How is AMD treated?
`
`Early AMD
`
`Currently, no treatment exists for early AMD, which in many
`people shows no symptomsor 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
`
`whether this formulation could be improved by adding
`
`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 diseasein
`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
`
`SamsungBioepis Exhibit 1027 - Page 13
`Biocon Exhibit 1027 - Page 13
`
`
`
`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.”
`
`10
`
`Samsung Bioepis Exhibit 1027 - Page 14
`Biocon Exhibit 1027 - Page 14
`
`
`
`If you have intermediate or late AMD, you might benefit
`from taking such supplements. But first, be sure to review
`and comparethe 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.
`
`of all tested genotypes. Based on the overall data, the
`
`You maysee 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
`
`Even if you take a daily multivitamin, you should consider
`taking an AREDS supplementif you are at risk for late AMD.
`The formulations tested in the AREDS trials contain much
`
`higher doses of vitamins and minerals than whatis found
`in multivitamins. Tell your doctor or eye care professional
`about any multivitamins you are taking when you are
`discussing possible AREDS formulations.
`
`SamsungBioepis Exhibit 1027 - Page 15
`Biocon Exhibit 1027 - Page 15
`
`
`
`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.
`
`12
`
`Samsung Bioepis Exhibit 1027 - Page 16
`Biocon Exhibit 1027 - Page 16
`
`
`
`e Photodynamic therapy. This technique involves laser
`treatmentof 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 bloodvessels, while
`sparing normal ones. Onceactivated, the drug closes off
`the new bloodvessels, slows their growth, and slows the
`rate of vision loss. This procedureis less common than anti-
`VEGF injections, and is often used in combination with
`them for specific types of neovascular AMD.
`
`prevent moreseverevision loss from occurring yearslater.
`
`e Laser surgery. Eye care professionals treat certain cases
`of neovascular AMD withlaser surgery, though thisis less
`common than other treatments.It involves aiming an
`intense “hot” laser at the abnormal bloodvessels in your
`eyes to destroy them. This laser is not the same one used
`in photodynamic therapy which maybereferred to as a
`“cold” laser. This treatment is morelikely to be used when
`blood vessel growthis limited to a compact area in your
`eye, away from the center of the macula, that can beeasily
`targeted with the laser. Even so, laser treatment also may
`destroy some surrounding healthytissue. This often results
`in asmall blind spot wherethe 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
`
`SamsungBioepis Exhibit 1027 - Page 17
`Biocon Exhibit 1027 - Page 17
`
`
`
`professional about treatment
`
`Whatis the treatment for advanced
`neovascular AMD?
`
`When will treatment start and how long will it
`last?
`
`Whatare the benefits of this treatment and
`how successful is it?
`
`Whatare the risks and side effects associated
`with this treatment and how has this
`information been gathered?
`Should | avoid certain foods, drugs, or activities
`while | am undergoing treatment?
`Are other treatments available?
`
`When should | follow up after treatment?
`
` Questions to ask your eye care
`
`How can I! cope with vision loss?
`
`Coping with AMD andvision 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 meansthat
`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 keyis to not delay use of theseservices.
`
`SamsungBioepis Exhibit 1027 - Page 18
`Biocon Exhibit 1027 - Page 18
`
`
`
`What You Can Do
`
`Whatis 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 workersare also available to help.
`Together, the low vision team can help you make the most
`of your remaining vision and maintain your independence.
`
`therapy, call 1-800-—MEDICARE or 1-800-633-4227.
`
`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 ofservices, 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
`
`SamsungBioepis Exhibit 1027 - Page 19
`Biocon Exhibit 1027 - Page 19
`
`
`
`Where can I go for services?
`
`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
`
`16
`
`Samsung Bioepis Exhibit 1027 - Page 20
`Biocon Exhibit 1027 - Page 20
`
`
`
` What You Can Do
`
`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 | 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?
`Wherecan | find individual or group support to
`cope with myvision loss?
`
`SamsungBioepis Exhibit 1027 - Page 21
`Biocon Exhibit 1027 - Page 21
`
`
`
`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
`
`18
`
`Samsung Bioepis Exhibit 1027 - Page 22
`Biocon Exhibit 1027 - Page 22
`
`
`
`What You Can Do
`
`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:
`
`e Learn more aboutyour vision loss.
`
`e Visit a specialist in low vision and get devices and learning
`skills to help you with the tasks of everydayliving.
`
`e Try to stay positive. People who remain hopeful say they
`are better able to cope with AMD and vision loss.
`
`e Stay engaged with family and friends.
`
`e Seek a professional counselor or support group. Your
`doctor or eye care professional may be able to refer you
`
`to one.
`
`Whatinformation can | 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 maylast longer. This can be upsetting to family
`members and caregivers who aretrying to be as caring and
`supportive as possible.
`
`
`
`SamsungBioepis Exhibit 1027 - Page 23
`Biocon Exhibit 1027 - Page 23
`
`
`
`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.”
`
`20
`
`Samsung Bioepis Exhibit 1027 - Page 24
`Biocon Exhibit 1027 - Page 24
`
`
`
`Current Research
`
`a
`
`= -
`
`Whatresearchis being done?
`
`NEI conducts and supports researchin labs and clinical centers
`across the country to better prevent, detect, and treat AMD.
`
`NEl-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 pathwaysinvolved 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.
`
`AMD—theyaretypically gone for good. However, lessons
`
`Scientists are also exploring ways to regeneratetissues
`destroyed by AMD. One approach is to make stem cells
`from a patient's ownskin or blood. In a lab, these stem cells
`can be specially treated to form sheets of retinal pigment
`epithelium (RPE)—the pigmentedlayer 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 preservevision.
`
`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 toinjury or diseaseslike
`
`SamsungBioepis Exhibit 1027 - Page 25
`Biocon Exhibit 1027 - Page 25
`
`
`
`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.
`
`22
`
`Samsung Bioepis Exhibit 1027 - Page 26
`Biocon Exhibit 1027 - Page 26
`
`
`
`Additional Resources
`
`Where can | get more information?
`
`For more information about age-related macular
`degeneration, you may wish to contact:
`
`American Academyof Ophthalmology
`P.O. Box 7424
`San Francisco, CA 94120-7424
`415-561-8500
`
`WWww.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
`
`
`
`SamsungBioepis Exhibit 1027 - Page 27
`Biocon Exhibit 1027 - Page 27
`
`
`
`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
`
`24
`
`Samsung Bioepis Exhibit 1027 - Page 28
`Biocon Exhibit 1027 - Page 28
`
`
`
`Additional Resources
`
`National EyeInstitute
`National Institutes of Health
`
`2020 Vision Place
`Bethesda, MD 20892-3655
`301-496-5248
`Email: 2020@nei.nih.gov
`www.nei.nih.gov
`
`www.preventblindness.org
`
`Prevent Blindness
`
`211 West Wacker Drive, Suite 1700
`Chicago, IL 60606
`1-800-331-2020
`Email: info@preventblindness.org
`
`SamsungBioepis Exhibit 1027 - Page 29
`Biocon Exhibit 1027 - Page 29
`
`
`
`Notes
`
`26
`
`Samsung Bioepis Exhibit 1027 - Page 30
`Biocon Exhibit 1027 - Page 30
`
`
`
`Samsung Bioepis Exhibit 1027 - Page 31
`Biocon Exhibit 1027 - Page 31
`
`
`
`Fe ESN STtL)
`
`U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
`National Institutes of Health
`National EyeInstitute
`Revised 9/15
`
`N | H
`
`
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
