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`Comparison of Anti-VEGF Treatments for Wet
`AMD
`
`Leer en Espanol : Com11araci6n de tratamientos de anti-VEGF 11ara DMRE humeda
`
`By Reena Mukamal
`Edited By Anni Delfaro
`Feb. 03, 2020
`
`Anti-VEGF drugs can prevent vision loss in patients with ~ge-related macular degeneration
`.(AMO)., a leading cause of blindness among older Americans. Here's a guide to the similarities and
`differences between four anti-VEGF drugs commonly used to treat wet AMO.
`
`Groundbreaking treatments for wet AMD
`In the United States, an estimated 11 million Americans have some form of AMO. This disease
`erodes central vision, complicating day-to-day activities such as reading, driving and identifying faces.
`AMO has two forms - wet and dry. While dry AMO leads to a gradual loss of vision, wet AMO leads to
`faster vision loss and is the most advanced form of the disease. It is responsible for 90 percent of all
`AMO-related blindness.
`
`A decade ago, wet AMO was considered untreatable and two-thirds of those affected could expect to
`be legally blind within two years of developing the disease. Today there is a very different story about
`wet AMO thanks to the introduction of injectable anti-vascular endothelial growth factor (anti-VEGF).
`drug§. The usage of anti-VEGF drugs has nearly halved the incidence of AMO-related blindness in
`some countries, and ophthalmologists are now able to help wet AMO patients maintain - and in some
`cases restore - vision.
`
`"This class of drugs represents a huge leap in treatment for macular degeneration, and doctors have
`been blown away by the results," said Rahul Khurana, MD, a clinical spokesperson for the American
`Academy of Ophthalmology and retina specialist. "Ten years ago, wet AMO was a one-way ticket to
`blindness, but now I have patients with the condition who are able to read and drive; and some even
`maintain 20/20 vision."
`
`Multiple anti-VEGF drugs are available to treat AMO, but four are commonly used for the condition.
`Three of these, ranibizumab (brand name Lucentis®), aflibercept (brand name Eylea®) and
`brolucizumab (brand name Beovu®), were designed specifically for the treatment of AMO. A fourth
`drug, bevacizumab (brand name Avastin®), was originally developed to treat various types of cancer,
`but is commonly used "off-label" in patients with AMO.
`
`As doctors and the media debate the relative merits and disadvantages of these drugs, the growing
`collective experience of ophthalmologists indicates that all four are safe and effective treatments for
`wetAMD.
`
`How do they work?
`Wet AMO occurs when abnormal blood vessels begin to grow underneath the retina and leak blood or
`fluid that blurs central vision. A chemical called vascular endothelial growth factor, or VEGF, causes
`this abnormal growth. Anti-VEGF treatments seek out harmful VEGF molecules and block them. This
`reduces abnormal growth and leakage, which helps to stabilize vision loss and, in some cases, can
`improve sight.
`
`Patients can receive treatment in their doctor's office. The ophthalmologist will place anesthetic and
`antiseptic drops on the eye to numb it, then administer the anti-VEGF drug by injection.
`
`
`https://www.aao.org/eye-health/diseases/avastin-eylea-lucentis-difference
`
`Novartis Exhibit 2260.001
`Regeneron v. Novartis, IPR2021-00816
`
`

`

`"An eye injection may sound scary, but the needle is very small and the injection is very quick - a
`fraction of a second: said Raj Maturi, MD. "Many of my patients are nervous about this the first time,
`but by the second treatment, they are much more confident in the process and its effectiveness."
`
`The recommended frequency of these injections varies from every few weeks to every few months,
`and duration of treatment varies by case. Patients will likely require multiple doses over the course of
`many months, and repeat treatments are often needed for continued benefit.
`
`How are they different?
`Lucentis, Eyles and Avastin offer similar visual benefits, according to many ophthalmologists, But
`Beovu is the first anti-VEGF drug to provide similar benefits with a single eye injection only four times
`a year,
`
`Here are some other differences that your ophthalmologist may explain to you as you discuss
`treatment options.
`
`FDA approval
`Lucentis, Eylea and Beovu have been FDA-approved for use in the eye. But Genentech, the
`company that manufactures Avastin and Lucentis, has not sought FDA approval for Avastin to be
`used as treatment of wet AMO.
`
`However, Avastin was FDA-approved as a treatment for colon cancer in February 2004, and since
`then has been used by ophthalmologists to treat wet AMO "off-label" with great resylts In fact, halt
`of ophthalmologists prescribe Avastin as a first-line treatment for wet AMO.
`
`Cost
`Avastin, at approximately $50 per average treatment, is significantly less expensive for the patient
`than the alternatives (-$1,800 to $2,000 for Eylea, Lucentis or Beovu).
`
`Eylea's and Lucentis' significantly higher price tags reflect the costly process of FDA approval for
`their intended use. Although Avastin carries a similarly high price tag when used for colon cancer,
`it is much less expensive as an eye treatment because only 1140th of the drug is being used for
`each dose.
`
`Price is often a deciding factor for patients. Drug manufacturers do offer some patient assistance
`programs to help subsidize costs. But for many individuals, the nearly $2,000 difference between
`these drugs and Avastin can add up to thousands of dollars or more in out-of-pocket costs over
`the course of treatment. This cumulative price differential has been the main focus of media
`stories about the drugs.
`
`Also related to the issue of cost is insurance coverage. All three drugs are covered by Medicare,
`but the terms of coverage can be complex. Not all injections may be covered by each insurance
`carrier.
`
`Risks
`Numerous studies have concluded that there are minimal differences in risk between the three
`drugs. A concern is that there is a greater possibility of infection with Avastin due to potential
`contamination when the drug is being repackaged into smaller doses for the eye, When
`appropriate guidelines are followed for preparing such medicines, this risk is minimized,
`Additionally, "in the vast majority of cases of eye infection, the source is the surface of the patient's
`own eye, rather than contaminated medication or anything else," said Abdish Bhavsar, M.D.,
`Academy clinical spokesperson and retina specialist,
`
`Packaging and accesslblllty
`Since Lucentis, Eylea and Beovu are FDA approved for use in the eye, they are manufactured and
`delivered to ophthalmologists as eye injectables, usually stored in the ophthal mologist's office and
`available for use whenever they are needed.
`
`Avastin, in contrast, is a repackaged drug. It is shipped from the manufacturer to a special
`pharmacy that repackages it into smaller doses for the eye and then delivers it to doctors' offices.
`If you and your ophthalmologist decide that Avastin is right for you, you may have to come back
`for a second appointment to receive the treatment. In most cases your doctor will be able to pre(cid:173)
`order your prescription each month and have it ready for your subsequent appointments,
`minimizing this issue after the initial treatment.
`
`Which treatment is right for you?
`Multiple studies have compared these anti-VEGF drugs and found that all help patients retain their
`abil ity to see. So the American Academy of Ophthalmology recommends that ophthalmologists
`counsel patients about the availabil ity of these treatments.
`
`Patients may differ in how their eyes respond to one treatment versus another, Additionally, there may
`be cause at some point during a patient's course of treatment for the ophthalmologist to switch
`patients from one drug to another, Your ophthalmologist will help you pick a therapy after reviewing
`your unique condition and the relative tradeoffs of these treatments,
`https://www.aao.org/ eye-health/diseases/avastin-eylea-lucentis-difference
`
`Novartis Exhibit 2260.002
`Regeneron v. Novartis, IPR2021-00816
`
`

`

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`https://www.aao.org/ eye-health/diseases/avastin-eylea-lucentis-difference
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`Novartis Exhibit 2260.003
`Regeneron v. Novartis, IPR2021-00816
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`https://www.aao.org/eye-health/diseases/avastin-eylea-lucentis-difference
`
`Novartis Exhibit 2260.004
`Regeneron v. Novartis, IPR2021-00816
`
`