Biomedical Literature List
`XP-002674126
`Thomson Reuters Integrity
`Copyright 2012 - Prous Science. All rights reserved.
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`rertReference
`Regeneron Pharmaceuticals Press Release 2008, September 28
`Title
`VEGF Trap-Eyefinal phase II results in age-related macular degeneration presented at 2008 Retina
`Society Meeting
`Aflibercept (303153)
`Regeneron and Bayer announce that VEGF Trap-Eye achieved durable improvementsin visual acuity
`and in biologic measures of neovascular disease, including retinal thickness and active choroidal
`neovascularization lesion size, for up to one year ina phase II study in neovascular (wet) age-
`related macular degeneration (AMD). In this double-blind trial, patients were initially treated with
`either fixed monthly or quarterly dosing for 12 weeks and then continued to receive treatment for
`another 40 weeks on a PRN (as needed) dosing schedule. Patients receiving monthly doses of VEGF
`Trap-Eye of either 2.0 or 0.5 mg for 12 weeks followed by PRN dosing achieved mean improvements
`in visual acuity versus baseline of 9.0 letters and 5.4 letters, respectively, at the end of one year.
`The propertion of patients with vision of 20/40 or better increased from 23%at baseline to 45%at
`week 52 in patientsinitially treated with 2.0 mg monthly and from 16%at baseline to 47%at week
`52 in patients initially treated with 0.5 mg monthly. During the week 12 to week 52 PRN dosing
`period, patients initially dosed on a 2.0 mg monthly schedule received, on average, only 1.6
`additional injections and thoseinitially dosed on a 0.5 mg monthly schedule received, on average,
`2.5 injections. Patients receiving monthly doses of VEGF Trap-Eye of either 2.0 or 0.5 mg for 12
`weeks followed by PRN dosing also achieved mean decreasesin retinal thickness versus baseline of
`143 microns and 125 micrans at week 52, respectively. While PRN dosing following a fixed quarterly
`dosing regimen (with dosing at baseline and week 12) also yielded improvements in visual acuity
`andretinal thickness versus baseline at week 52, the results generally were not as robust as those
`obtained with initial fixed monthly dosing. VEGF Trap-Eye was also associated with a reduction in the
`size of the total active choroidal neovascular membrane (CNV). Patients initially receiving either a
`2.0 mg or 0.5 mg monthly fixed dose of VEGF Trap-Eye for 12 weeks followed by PRN dosing
`experienced statistically significant 3.41 mm(2) and 1.42 mm(2) reductions in mean CNV size at 48
`weeks (the final one-year analysis from the independent reading center) versus baseline,
`respectively. Patients in the 2.0 mg monthly cohort also achieved a statistically significant 1.75 mm
`(2) reduction in total lesion size. A reduction in total lesion size was not seen in the cohort initially
`dosed with 0.5 mg monthly. VEGF Trap-Eye was generally well tolerated and there were no drug-
`related serious adverse events. Regeneron and Bayer HealthCare initiated a phase III global
`development program for VEGF Trap-Eye in wet AMDin August 2007. In two phaseIII trials, the
`companies are evaluating VEGF Trap-Eye dosed 0.5 mg every 4 weeks, 2 mg every 4 weeks, or 2 mg
`every 8 weeks (following three monthly doses) in direct comparison with ranibizumab (Lucentis[R})
`administered 0.5 mg every 4 weeks. PRN dosing will be evaluated during the second year of each
`study. The VIEW1 study is currently enrolling patients in the U.S. and Canada and the VIEW2 study
`is currently enrolling patients in Europe, Asia Pacific, Japan, and Latin America. The VEGF Trap-Eye is
`a fully human, soluble VEGF receptor fusion protein that binds all forms of VEGF-A along with the
`related placental growth factor (PIGF).
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`
`Exhibit 2007 Regeneron Exhibit 2007
`
`Mylan v. Regeneron
`IPR2021-00880
`U.S. Pat. 9,669,069
`
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`18-04-2012
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`Regeneron Exhibit 2007
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