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`Regeneron Announces FDA Approval of EYLEA™ (aflibercept) Injection for the Treatment of Wet Age-Related Macular Degenerati…
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`Biotech
`Regeneron Announces FDA Approval of EYLEA™ (aflibercept) Injection for the Treatment of
`Wet Age-Related Macular Degeneration
`Nov 18, 2011 5:56pm
`EYLEA is the only FDA-approved treatment for wet AMD labeled for less than monthly dosing that demonstrated
`clinical equivalence to the monthly standard of care
`Regeneron to host conference call on November 18, at 6:30 p.m. Eastern Time
`TARRYTOWN, N.Y., Nov. 18, 2011 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN) today
`announced that the U.S. Food and Drug Administration (FDA) has approved EYLEA (aibercept) In jection , known in
`the scientic literature as VEGF Trap-Eye, for the treatment of patients with neovascular (wet) Age-related Macular
`Degeneration (AMD) at a recommended dose of 2 milligrams (mg) every four weeks (monthly) for the rst 12 weeks,
`followed by 2 mg every eight weeks (2 months).
`The approval of EYLEA was granted under a Priority Review, a designation that is given to drugs that oer ma jor
`advances in treatment, or provide a treatment where no adequate therapy exists. This approval was based upon the
`results of two Phase 3 clinical studies. In these studies, EYLEA dosed every eight weeks, following three initial
`monthly in jections, was clinically equivalent to the standard of care, Lucentis® (ranibizumab in jection) dosed every
`four weeks, as measured by the primary endpoint of maintenance of visual acuity (less than 15 letters of vision loss
`on an eye chart) over 52 weeks. The most common adverse reactions (frequency of 5% or more) reported in
`patients receiving EYLEA were con junctival hemorrhage, eye pain , cataract, vitreous detachment, vitreous oaters,
`and increased intraocular pressure. The adverse event prole was similar to that seen with ranibizumab.
`"The approval of EYLEA oers a much needed new treatment option for patients with wet AMD," said Jerey Heier,
`M.D., a clinical ophthalmologist and retinal specialist at Ophthalmic Consultants of Boston , Assistant Professor of
`Ophthalmology at Tufts School of Medicine, and Chair of the Steering Committee for the VIEW 1 trial. "EYLEA oers
`the potential of achieving the ecacy we've come to expect from current anti-VEGF agents, but with less frequent
`in jections and no monitoring requirements. This may reduce the need for costly and time-consuming monthly
`oce visits for patients and their caregivers."
`"This approval is an important step forward for Regeneron and for patients suering with wet AMD, the most
`common cause of blindness in the U.S. in older adults," said Leonard S. Schleifer, M.D., Ph.D., President and Chief
`Executive Ocer of Regeneron. "We thank the patients and clinical investigators who participated in our clinical
`

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`2/4/22, 5:41 PM
`
`Regeneron Announces FDA Approval of EYLEA™ (aflibercept) Injection for the Treatment of Wet Age-Related Macular Degenerati…
`
`https://www.fiercebiotech.com/biotech/regeneron-announces-fda-approval-of-eylea™-aflibercept-injection-for-treatment-of-wet-age
`
`2/3
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`Exhibit 2107
`Page 02 of 03
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`studies, the FDA, and the Regeneron employees who helped make this day possible. Now that EYLEA is approved,
`we plan to make EYLEA available to patients within the next few days."
`About EYLEA
`TM
` (aibercept) In jection
`Vascular Endothelial Growth Factor (VEGF) is a naturally occurring protein in the body. Its normal role in a healthy
`organism is to trigger formation of new blood vessels (angiogenesis) supporting the growth of the body's tissues
`and organs. However, in certain diseases, such as wet age-related macular degeneration , it is also associated with
`the growth of abnormal new blood vessels in the eye, which exhibit abnormal increased permeability that leads to
`edema. Scarring and loss of ne-resolution central vision often results.
`EYLEA, known in the scientic literature as VEGF Trap-Eye, is a recombinant fusion protein , consisting of portions of
`human VEGF receptors 1 and 2 extracellular domains fused to the Fc portion of human IgG1 and formulated as an
`iso-osmotic solution for intravitreal administration. EYLEA acts as a soluble decoy receptor that binds VEGF-A and
`placental growth factor (PlGF) and thereby can inhibit the binding and activation of these cognate VEGF receptors.
`EYLEA is indicated for the treatment of patients with neovascular age-related macular degeneration (wet AMD).
`EYLEA is contraindicated in patients with ocular or periocular infections, active intraocular inammation , or known
`hypersensitivity to aibercept or to any of the excipients in EYLEA.
`The recommended dose for EYLEA is 2 mg administered by intravitreal in jection every four weeks (monthly) for the
`rst 12 weeks (3 months), followed by 2 mg once every eight weeks (2 months). Although EYLEA may be dosed as
`frequently as 2 mg every four weeks (monthly), additional ecacy was not demonstrated when EYLEA was dosed
`every four weeks compared to every eight weeks.
`There is a potential risk of arterial thromboembolic events (ATEs) following use of intravitreal VEGF inhibitors,
`including EYLEA, dened as nonfatal stroke, nonfatal myocardial infarction , or vascular death (including deaths of
`unknown cause). The incidence of ATEs with EYLEA in clinical trials was low (1.8%).
`Serious adverse reactions related to the in jection procedure have occurred in less than 0.1% of intravitreal
`in jections with EYLEA and include endophthalmitis, traumatic cataract, and increased intraocular pressure.
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`2/4/22, 5:41 PM
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`Regeneron Announces FDA Approval of EYLEA™ (aflibercept) Injection for the Treatment of Wet Age-Related Macular Degenerati…
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