2/4/22, 4:34 PM
`
`FDA Approves Eylea for Wet Age-Related Macular Degeneration
`
`FDA Approves Eylea
`FDA Approves Eylea for Wet Age-Related Macular Degeneration
`
`November 18, 2011 -- The U.S. Food and Drug Administration today approved Eylea (aflibercept) to
`treat patients with wet (neovascular) age-related macular degeneration (AMD), a leading cause of
`vision loss and blindness in Americans ages 60 and older.
`
`AMD gradually destroys a person’s sharp, central vision. It affects the macula, the part of the eye
`that allows people to see fine detail needed to do daily tasks such as reading and driving.
`
`There are two forms of AMD, a wet form and a dry form. The wet form of AMD includes the growth
`of abnormal blood vessels. The blood vessels can leak fluid into the central part of the retina, also
`known as the macula. When fluid leaks into the macula, the macula thickens and vision loss occurs.
`An early symptom of wet AMD occurs when straight lines appear to be wavy.
`
`“Eylea is an important new treatment option for adults with wet AMD,” said Edward Cox, M.D.,
`M.P.H, director of the Office of Antimicrobial Products in FDA’s Center for Drug Evaluation and
`Research. “It is a potentially blinding disease and the availability of new treatment options is
`important.”
`
`The safety and effectiveness of Eylea was evaluated in two clinical trials involving 2,412 adult
`patients. People in the study received either Eylea or Lucentis (ranibizumab injection). The primary
`endpoint in each study was a patient’s clearness of vision (visual acuity) after one year of treatment.
`
`Eylea is injected into the eye either every four weeks or every eight weeks by an ophthalmologist.
`The studies showed that Eylea was as effective as Lucentis in maintaining or improving visual
`acuity.
`
`The most commonly reported side effects in patients receiving Eylea included eye pain, blood at the
`injection site (conjunctival hemorrhage), the appearance of floating spots in a person’s vision
`(vitreous floaters), clouding of the eye lens (cataract), and an increase in eye pressure.
`
`Eylea should not be used in those who have an active eye infection or active ocular inflammation.
`Eylea has not been studied in pregnant women, so the treatment should be used only in pregnant
`women if the potential benefits of the treatment outweigh any potential risks. Age related macular
`degeneration does not occur in children and Eylea has not been studied in children.
`
`https://www.drugs.com/newdrugs/fda-approves-eylea-wet-age-related-macular-degeneration-2955.html
`
`1/2
`
`Exhibit 2115
`Page 01 of 02
`
`

`

`2/4/22, 4:34 PM
`FDA Approves Eylea for Wet Age-Related Macular Degeneration
`Other FDA-approved treatment options for wet AMD include: Visudyne (verteporfin for injection)
`approved in 2000, Macugen (pegaptanib sodium injection) approved in 2004, and Lucentis
`(ranibizumab injection) approved in 2006.
`
`Eylea is marketed by Tarrytown, N.Y.-based Regeneron Pharmaceuticals Inc.
`
`Posted: November 2011
`
`Related Articles:
`FDA Approves Eylea (aflibercept) Injection Prefilled Syringe - August 13, 2019
`
`FDA Approves Eylea (aflibercept) Injection for Diabetic Retinopathy - May 13, 2019
`
`FDA Approves New Eylea (aflibercept) Injection Dosing Schedule in Wet Age-Related Macular
`Degeneration - August 17, 2018
`
`FDA Approves Eylea (aflibercept) for Diabetic Retinopathy in Patients with Diabetic Macular
`Edema - March 25, 2015
`
`Eylea (aflibercept) Injection Receives FDA Approval for the Treatment of Diabetic Macular
`Edema - July 29, 2014
`
`Regeneron Announces Review of Biologics License Application for Eylea (aflibercept injection)
`Extended by Three Months by FDA - August 17, 2011
`
`Regeneron Announces Eylea (aflibercept ophthalmic solution) Receives Unanimous
`Recommendation for Approval for Treatment of Wet AMD from FDA Advisory Committee - June
`17, 2011
`
`Eylea (aflibercept) FDA Approval History
`
`https://www.drugs.com/newdrugs/fda-approves-eylea-wet-age-related-macular-degeneration-2955.html
`
`2/2
`
`Exhibit 2115
`Page 02 of 02
`
`