`
`
`
`
`
`Interim Analysis of Phase 2 Study of VEGF Trap in AMD patients
`
`Patients treated with 5 different dosing regimens, and compared to their own baseline over the course of
`
`
`
`
`
`
`
`
`
`
`
`
`three months, using change in retinal thickness at three months as the primary endpoint, with
`
`
`
`
`changes in visual acuity as the key secondary endpoint
`
`Patients treated with 0.5 mg, 2.0 mg and 4.0 mg doses, with cohorts in which each patient was treated just
`
`
`
`
`
`
`
`
`
`
`
`once with these doses and evaluated over the ensuing three months, as well as cohorts in the
`0.5 and 2.0 doses were given monthly
`
`
`
`Study achieved its pre-specified primary endpoint, of decrease in retinal thickness in all treated patients (all
`
`
`
`
`
`
`
`
`
`
`
`cohorts combined) at 12 weeks, with p < 0.0001
`
`
`
`
`
`
`>>> The average decrease in retinal thickness across all five cohorts was 135 microns
`
`Study also achieved key pre-specified secondary endpoint, of improvement in visual acuity in all treated
`
`
`
`
`
`
`
`
`
`
`
`
`
`patients (all cohorts combined) at 12 weeks, with p < 0.0001
`
`
`
`
`
`
`
`
`
`
`
`at 8 weeks, and 5.9 letters at 12 weeks
`
`>>> The average increase in visual acuity across all five cohorts was 6.0 letters at 4 weeks, 5.8 letters
`
`Statistical analyses did not show significant differences across the treatment groups, for changes in either
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`retinal thickness or visual acuity, regardless of whether patients were treated with a single
`
`
`dose or received monthly treatments
`
`
`
`
`
`
`
`
`
`
`
`>>> The improvements in visual acuity in the different cohorts ranged from 3 to 10 letters at 12 weeks
`
`Patients treated with a single dose, at all three dose levels, maintained a decrease in retinal thickness as well
`
`
`
`
`
`
`
`
`
`
`
`
`as a gain in visual acuity (2.8 to 5.1 letters), at 12 weeks
`
`Only a single patient in the entire study did not at least maintain their vision, as defined by loss of 3 or more
`
`
`
`
`
`
`
`
`lines of vision at three months
`
`Quote:
`"In this 12 week study, the VEGF Trap caused statistically significant improvements in both retinal swelling
`
`
`
`
`
`
`
`
`
`
`and visual acuity. Moreover, the VEGF Trap may prove unique in that a single dose may be able to maintain
`
`
`
`
`
`
`
`a beneficial effect on retinal swelling, as well as improve visual acuity, for at least twelve weeks. We look
`
`
`
`
`
`forward to the required Phase 3 studies to define the doses and intervals that will provide the most benefit
`
`
`
`and most desirable treatment options for patients."
`
`
`
`Key Background Comparisons to Lucentis:
`
`
`
`
`
`Mean change in VA at lm, 3m and 1 year in Lucentis pivotal studies:
`
`
`
`
`
`l m 3m
`
`12m
`
`0.3
`6.5
`Marina
`-3.55.1
`(2mETDRS)
`7.2
`0.5
`-4 5.9
`
`Anchor
`
`5.96.8
`0.3
`8.5
`
`CONFIDENTIAL
`
`RGN-EYLEA-MYLAN-00525766
`
`Regeneron Pharmaceuticals, Inc. Exhibit 2006 Page 1
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc. IPR2023-00884
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Regeneron Pharmaceuticals, Inc. Exhibit 2006 Page 2
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc. IPR2023-00884
`
`