. ExP.,ert
`Opinion
`
`Introduction
`1.
`2. Background
`
`3. Conclusion
`4. Expert opinion
`
`mss
`
`Drug Evaluation
`
`VEGF Trap-Eye for the treatment
`of neovascular age-related
`macular degeneration
`James A Dixon, Scott CN Oliver\ Jeffrey L Olson & Naresh Mandava
`Univer1ity of Colorado Denver, Rocky Mountain Liom Eye Institute, Department of Ophthalmology.
`1675 North Aurora Court, PO Box 6510, .Mail Stop F-731, Aurora, CO 80045-2500, USA
`
`Background: Age-related macular degeneration (AMD} affects> 14 million
`individuals worldwide. Although 90% of patients with AMD have the dry
`form, neovascular AMO accounts for the vast majority of patients Who
`develop legal blindness. Until recently, few treatment options existed for
`treatment of neovascular AMD. The advent of anti-VEGF therapy has sig(cid:173)
`nificantly improved the safe and effective treatment of neovascular AMO.
`In addition to two anti-VEGF drugs currently in widespread use, ranibizumab
`and bevacizumab. a. number of medications tnar interrupt angiogenesis are
`currently under investigation.(One_Qromisirrg"_new dru!'.Us aflibeTcept:M§f,l
`CT@p;£Eye), a fusion protein that:bloc._ksfall isoforms'igf'VEGF.-A\andwlacental)
`(growth factors-1 and -2.0bj~ctivdTo reviewtti}~rre~\!_~(ature and clini(cid:173)
`cal trial data regarding VEGF Trap-Eye for),the tre,hrnentJof neovascular
`AMD. Methods: Literature review. ,Res'"W't;lconctusi'tin: .VEGF Trap-Eye is a
`novel anti-VEGF therapy, with Phase'l1~d II tri;l"~~ta·ih<aicating safety, toler-
`cu , ~,._
`."' ... "6-.,;
`"i,'-.1-
`~---
`ability and efficacy for the treatment of neovascular~ A,MD. Two Phase Ill clini-
`cal trials (VlEW-1 and VIEvyfif"'comJ)~jn~ ViGF"'Jrat-Eye to ~an.ibizumab are
`currently continuing ariitwill proviaJ•vitat.ifuight into the clinical applicability
`~'"'!)
`c,O• ,._ .v--.;:,.""~0 o-·
`. . /
`• r,,,,.~"'
`of this drug.
`.... __ ., _,_ .Cl,.-,, . AMDf'C: ~ . ,-/P';,!-.~ 'l>., lari
`;t
`. ,;f>
`_ · _, ~gtogei::ies1s,.11eovascu
`.. -.7 -o~: ai:µOf.?rCeptJ
`r-7>"
`r.v •
`0 ·, 6 ,,
`'fl."'
`~ ,..:f.i
`V
`Expert Opin. Invest,/ Dmg1J2009)'i8(10):l-8
`''-"°"'
`,,
`o'··
`r.:: \.
`0'<S' ~,z,.'\
`1. lntayducti&~<.,,'Q·
`
`. VEG_F.,,VEGF. h'b' . VEGF 1i
`rap
`·
`1n 1 1t1on,
`zanon;·
`,
`, /"
`.
`
`~'D
`
`Age-related macular degeneration (AMD) affects > 1.75 million individuals in the
`US and it is estimated that by 2020 this number will increase to almost 3 million t!J.
`Worldwide, AMD 1s estimated to affect 14 million people [2J. While the vast major(cid:173)
`ity of patients suffering from AMD have the dry form, - 80 - 90% of patients who
`develop severe vision loss have the neovascular or 'wet' form of the disease [3]. Until
`recently, healthcare professionals had few options when it came to treating neovascular
`AMO. For many years, subfoveal choroidal neovascularization (CNV) was treated
`with argon laser therapy according ro guidelines from the Macular Photocoagulation
`Study 14-12]. This treatment, in the setting of subfoveal disease, was unsatisfactory for
`a number of reasons, including the limited benefits in visual stabilization and the
`high risk of inducing central vision deficits [13J. Treatment outcomes improved with
`the inuoduccion of photodynamic therapy (PDT) which utilized a photosensitizing
`dye (verteporfin) to selectively target Cl'-.'V. While more efficacious than previous
`treatments, patients receiving PDT failed to recover vision and continued to experi(cid:173)
`ence a decline in visual acuity [14J and the rrearment was of questionable cost
`effectiveness [15].
`largely
`The more recent development of agents that inhibit VEGF has
`supplanted these previous treatments. The pathogenesis of CNV in the setting of
`
`i0.1517/13543780903201684 © 2009 lnforma UK ltd ISSN 1354-3784
`All rights reserved: reproduction in whole or in part not permitted
`
`1
`
`informa
`
`healthcare
`
`5
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`40
`
`45
`
`50
`
`54
`
`Mylan Exhibit 1087
`Mylan v. Regeneron, IPR2021-00880
`Page 1
`
`