VEGF Trap-Eye in Wet AMD
`CLEAR-IT 2: Summary of One-Year
`Key Results
`Presented at 2008 Retina Society Meeting
`Scottsdale, Arizona
`September 28, 2008
`
`A Phase 2, Randomized, Controlled
`Dose- and Interval-Ranging Study
`of Intravitreal VEGF Trap-Eye
`in Patients With Neovascular,
`Age-Related Macular Degeneration
`
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`Mylan v. Regeneron, IPR2021-00881
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`CLEAR-IT 2: Summary of One-Year
`Key Results
`Presented at 2008 Retina Society Meeting
`Scottsdale, Arizona
`September 28, 2008
`
`A Phase 2, Randomized, Controlled
`Dose- and Interval-Ranging Study
`of Intravitreal VEGF Trap-Eye
`in Patients With Neovascular,
`Age-Related Macular Degeneration
`
`1
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`CLEAR-IT 2: Rationale
`
`(cid:121) Anti-VEGF therapy has dramatically changed the treatment
`paradigm for wet AMD
`– Improvement in visual acuity is now an achievable goal of treatment
`(cid:121) A potential limitation of anti-VEGF therapy is the unpredictable
`durability of vision gain initially achieved with monthly dosing
`when the treatment interval is prolonged
`(cid:121) VEGF Trap-Eye is a novel anti-VEGF therapy with high binding
`affinity for VEGF-A and placental growth factor (PlGF)
`(cid:121) CLEAR-IT 2 was designed to assess:
`– Response at 12 weeks to a range of doses administered monthly and
`quarterly
`– Durability of response with PRN (as-needed) dosing out to 1 year
`
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`CLEAR-IT 2: Study Design
`
`Randomized, multicenter,
`double-masked trial
`N=159
`
`Subjects randomized
`1:1:1:1:1
`
`0.5 mg q4 wks
`n=32
`
`2 mg q4 wks
`n=32
`
`0.5 mg q12 wks
`n=32
`
`2 mg q12 wks
`n=32
`
`4 mg q12 wks
`n=31
`
`Primary endpoint:
`Primary endpoint:
`Change in Central Retinal/Lesion
`Change in Central Retinal/Lesion
`Thickness (CR/LT)
`Thickness (CR/LT)
`
`Fixed dosing to week 12 (primary
`endpoint)
`
`Secondary endpoint:
`Secondary endpoint:
`BestBest--Corrected ETDRS Corrected ETDRS
`
`Visual Acuity (BCVA)
`Visual Acuity (BCVA)
`
`PRN dosing to 1 year
`
`dosed at week 12; PRN dosing started at week 16
`Patients were rePatients were re--dosed at week 12; PRN dosing started at week 16
`
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`Study Schedule
`(fixed-dosing phase)
`
`Weeks
`
`0
`
`4
`
`8
`
`12
`
`0.5 mg q4 wks
`
`0.5 mg q12 wks
`
`2 mg q4 wks
`
`2 mg q12 wks
`
`4 mg q12 wks
`
`0.5 mg q4 wks VEGF Trap
`
`0.5 mg q12 wks VEGF Trap
`
`2 mg q12 wks VEGF Trap
`
`2 mg q4 wks VEGF Trap
`
`4 mg VEGF Trap
`
`Primary and Secondary
`Endpoints
`
`4
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`Study Schedule
`(fixed-dosing phase)
`
`Weeks
`
`0
`
`4
`
`8
`
`12
`
`0.5 mg q4 wks
`
`0.5 mg q12 wks
`
`2 mg q4 wks
`
`2 mg q12 wks
`
`4 mg q12 wks
`
`4 mandatory doses
`
`2 mandatory doses
`
`4 mandatory doses
`
`2 mandatory doses
`
`2 mandatory doses
`
`0.5 mg q4 wks VEGF Trap
`
`0.5 mg q12 wks VEGF Trap
`
`2 mg q12 wks VEGF Trap
`
`2 mg q4 wks VEGF Trap
`
`4 mg VEGF Trap
`
`Primary and Secondary
`Endpoints
`
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`Study Schedule
`
`Weeks
`
`0
`
`4
`
`8
`
`12
`
`0.5 mg q4 wks
`
`0.5 mg q12 wks
`
`2 mg q4 wks
`
`2 mg q12 wks
`
`4 mg q12 wks
`
`16
`
`prn
`
`prn
`
`prn
`
`prn
`
`prn
`
`…1 year
`
`…1 year
`
`…1 year
`
`…1 year
`
`…1 year
`
`0.5 mg q4 wks VEGF Trap
`
`0.5 mg q12 wks VEGF Trap
`
`2 mg q12 wks VEGF Trap
`
`2 mg q4 wks VEGF Trap
`
`4 mg VEGF Trap
`
`Primary and Secondary
`Endpoints
`
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`Baseline Characteristics
`
`(n=157*)
`
`Age (years)
`Gender (% M:% F)
`Disease Duration (months)
`Lesion Size (mean±SD) in disc areas
`Lesion Type: number (%)
`Classic
`Predominantly Classic
`Minimally Classic
`Occult Lesions
`Disease Status
`Central Retinal/Lesion Thickness
`Foveal Thickness
`ETDRS BCVA (letters)
`
`Mean
`78.2
`
`3.9
`
`Range
`53-94
`
`0-67
`
`38:62
`
`3.11±2.12
`
`30 (19.1)
`30 (19.1)
`37 (23.6)
`60 (38.2)
`
`456 µm
`327 µm
`56
`
`186-1316 µm
`116-1081 µm
`27-83
`
`*N=159 randomized; n=157 treated
`
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`Patient Disposition
`
`0.5 q4
`
`0.5 q12
`
`2 q4
`
`2 q12
`
`4 q12
`
`32
`
`32
`
`26
`
`6
`
`3
`
`1
`
`1
`
`1
`
`32
`
`32
`
`26
`
`6
`
`1
`
`1
`
`2
`
`2
`
`32
`
`31
`
`29
`
`2
`
`1
`
`1
`
`32
`
`31
`
`27
`
`4
`
`2
`
`1
`
`1
`
`31
`
`31
`
`26
`
`5
`
`1
`
`1
`
`1
`
`1
`
`1
`
`No. of Patients
`Screened
`Randomized
`Treated
`Completed Wk 52
`Withdrawn by Wk 52
`Reason for Withdrawal
`Non-compliance
`Subject request
`
`Adverse event
`Investigator decision
`
`Sponsor decision
`Lost to follow-up
`Death
`
`Other
`
`All Patients
`301
`159
`157
`134 (84.3%)
`23 (14.5%)
`
`1 (0.6%)
`6 (3.8%)
`1 (0.6%)
`2 (1.3%)
`3 (1.9%)
`3 (1.9%)
`2 (1.3%)
`5 (3.1%)
`
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`Primary Endpoint Results: Reported at
`2007 Retina Society
`
`At 12 weeks VEGF Trap-Eye:
`(cid:121) Significantly improved mean visual acuity
`(cid:121) Significantly reduced central retinal thickness
`(cid:121) Groups dosed at Baseline and at Week 12 showed
`improved visual acuity and retinal thickness
`– Effect was not as robust as with monthly dosing
`(cid:121) Maintained effect on visual acuity with a single dose to 8
`weeks
`(cid:121) Was generally well tolerated with no drug-related serious
`adverse events
`
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`Number of Doses
`Administered
`
`10
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`Re-dosing Criteria
`(starting at week 16)
`
`(cid:121) Increase in central retinal thickness of ≥100μm as
`measured by OCT, or;
`(cid:121) A loss of ≥ 5 ETDRS letters in conjunction with
`recurrent fluid as indicated by OCT, or;
`(cid:121) Persistent fluid as indicated by OCT, or;
`(cid:121) New onset classic neovascularization, or;
`(cid:121) New or persistent leak on FA, or;
`(cid:121) New macular hemorrhage
`
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`Re-Treatment Outcome
`
`Number of injections over PRN phase*
`
`VEGF Trap-Eye
`
`0.5 mg q4
`2 mg q4
`0.5 mg q12
`2 mg q12
`4 mg q12
`All
`
`Mean
`
`2.52
`1.55
`1.84
`2.48
`1.7
`2.01
`
`Median
`
`Range
`
`2
`1
`2
`3
`1
`2
`
`0 – 9
`0 – 4
`0 – 4
`0 – 5
`0 – 7
`0 – 9
`
`All patients, n=152
`
`* After the week 12 injection through week 52
`
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`Re-Treatment Outcome
`Mean number of
`Median number
`days to first
`of days to first
`injection over
`injection over
`PRN phase
`PRN phase
`(week 12 – 52)
`(week 12 – 52)
`
`Mean number of
`injections over
`PRN phase
`(week 12 – 52)
`
`VEGF Trap-Eye
`
`0.5 mg q4
`2 mg q4
`0.5 mg q12
`2 mg q12
`4 mg q12
`All
`
`2.52
`1.55
`1.84
`2.48
`1.7
`2.01
`
`102
`160
`133
`113
`138
`129
`
`85
`150
`86
`86
`111
`110
`
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`Distribution of Injections over PRN Phase
`(All groups combined)
`
`25%
`
`19%
`
`20%
`
`18%
`
`13%
`
`5%
`
`0
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`60
`50
`40
`30
`20
`10
`0
`
`# Patients
`
`Number of Injections
`Percent of patients receiving an injection analyzed by number of injections, n=152
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`Kaplan-Meier Curve
`Time to Re-injection (by treatment group)
`
`Time to 1st re-injection
`0.5q12
`0.5q4
`2.0q12
`2.0q4
`4.0q12
`Censored
`
`Median # of days to 1st re-injection
`in 2.0q4 group = 150
`
`100
`
`80
`
`60
`
`40
`
`20
`
`0
`
`Percent Patients
`
`0
`
`100
`
`200
`Days
`
`300
`
`400
`
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`Mean Change in Visual Acuity
`
`Fixed-dosing
`
`PRN-dosing Phase
`
`9.0*
`
`2q4
`
`5.4† 0.5q4
`
`*P < 0.0001
`†P = 0.085
`
`0
`
`4
`
`8 12 16 20 24 28 32 36 40 44 48 52
`
`0.5 mg q4
`
`2 mg q4
`
`12
`10
`
`02468
`
`Change in Visual Acuity (letters)
`
`Last Observation Carried Forward (LOCF) analysis; paired t-test; 0.5q4 : n=32; 2q4: n=31
`
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`Mean Change in Visual Acuity
`
`9.0*
`
`2q4
`
`5.4†
`5.2***
`4.2**
`2.6††
`
`0.5q4
`2q12
`4q12
`0.5q12
`
`*P < 0.0001
`**P = 0.0154
`***P = 0.0412
`†P = 0.085
`††P = 0.344
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`Fixed-dosing
`
`PRN-dosing Phase
`
`0
`
`4
`
`8
`
`12 16 20 24 28 32 36 40 44 48 52
`
`0.5q4
`
`2q4
`
`0.5q12
`
`2q12
`
`4q12
`
`12
`10
`
`02468
`
`Change in Visual Acuity (letters)
`
`LOCF analysis; paired t-test; 0.5q4 and 0.5q12: n=32; 2q4, 2q12, and 4q12: n=31
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`Mean Change in Central Retinal/Lesion
`Thickness
`
`Fixed-dosing
`
`0
`
`4
`
`8
`
`PRN-dosing Phase
`Week
`12 16 20 24 28 32 36 40 44 48 52
`
`-109*
`-112*
`-125*
`-143*
`-161†
`
`0.5q12
`2q12
`0.5q4
`2q4
`4q12
`
`*P < 0.0001
`†P = 0.0002
`
`0.5q4
`
`2q4
`
`0.5q12
`
`2q12
`
`4q12
`
`0
`
`-50
`
`-100
`
`-150
`
`-200
`
`-250
`
`Change in CR/LT (microns)
`
`Posterior Pole Scans; LOCF analysis; 0.5q4 and 0.5q12: n=32; 2q4, 2q12, and 4q12: n=31
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`Visual Acuity at Week 52
`
`100%
`
`100%
`
`97%
`
`88%
`
`88% 90%
`
`78% 81%
`
`74%
`
`71%
`
`59%
`
`29%
`
`29%
`
`22%
`
`19%
`
`10%
`
`80%
`
`60%
`
`40%
`
`20%
`
`0%
`
`Patients (%)
`
`<15 letters lost
`
`≥ 0 letter gain
`
`≥ 15 letter gain
`
`0.5q4
`
`2q4
`
`0.5q12
`
`2q12
`
`4q12
`
`LOCF analysis; 0.5q4 and 0.5q12: n=32; 2q4, 2q12, and 4q12: n=31
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`Proportion of Patients
`With ≥20/40 Vision
`
`47%
`
`45%
`
`45%
`
`34%
`
`36%
`
`23%
`
`22%
`
`16%
`
`16%
`
`10%
`
`BL Wk52
`0.5q4
`
`BL Wk52
`2q4
`
`BL Wk52
`0.5q12
`Dose Groups
`
`BL Wk52
`2q12
`
`BL Wk52
`4q12
`
`50%
`
`40%
`
`30%
`
`20%
`
`10%
`
`0%
`
`Patients (%) With
`
`≥20/40 Vision
`
`LOCF analysis; 0.5q4 and 0.5q12: n=32; 2q4, 2q12, and 4q12: n=31; BL=baseline;
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`Fluorescein Angiography
`1-Year Outcomes
`
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`DARC Reading Center:
`Definitions
`
`(cid:121) Total Lesion Size
`– Measurement of entire lesion including the classic and occult neo-
`vascular component as well as contiguous areas of blood and/or blocked
`fluorescence and/or serous pigment epithelial detachment (PED)
`(cid:121) Total Active CNV Size
`– Area of visible CNV (classic and/or occult) which demonstrates
`angiographic evidence of late leakage or pooling of dye
`(cid:121) Classic CNV
`– Area of bright, well-demarcated hyper-fluorescence in early phase, with
`progressive dye leakage into overlying sub-sensory retinal space in late
`phase of angiogram (not a measurement of area of leakage, but rather
`extent of the classic neo-vascular complex)
`(cid:121) Occult CNV
`– Angiogram shows staining or leakage from fibro-vascular PED or hyper-
`fluorescent leakage at level of RPE that represents late leakage of
`undetermined source (leakage in late phase without classic CNV or fibro-
`vascular PED to account for leakage)
`
`2222
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`Mean Change in Total Lesion Size
`by Fluorescein Angiography
`2.5
`2.0
`1.5
`1.0
`0.5
`0
`-0.5
`-1.0
`-1.5
`-2.0
`-2.5
`
`0.85†
`
`0.5q12
`
`- 0.01† 0.5q4
`- 0.04† 2q12
`-1.00† 4q12
`- 1.75* 2q4
`
`Fixed-dosing
`
`PRN-dosing Phase
`
`Change From Baseline (mm2)
`
`0
`
`4
`
`12
`
`Lesion Size at Baseline (mm2)
`
`0.5q4
`4.9
`
`2q4
`7.4
`
`24
`
`Week
`0.5q12
`5.5
`
`36
`
`2q12
`7.6
`
`48
`
`4q12
`6.5
`
`Mandatory FA only; LOCF analysis; 0.5q4 and 0.5q12: n=32; 2q4, 2q12, and 4q12: n=31
`
`*P = 0.04
`†P = NS
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`Mean Change in Total Active CNV Size
`by Fluorescein Angiography
`
`Fixed-dosing
`
`0
`
`4
`
`12
`
`Week
`
`PRN-dosing Phase
`
`24
`
`36
`
`48
`
`-1.35† 05q12
`-1.42** 0.5q4
`-2.29** 2q12
`-2.59** 4q12
`-3.41* 2q4
`
`4q12
`
`5.6
`
`*P < 0.001
`**P < 0.05
`†P = ns
`
`0.5q4
`
`2q4
`
`0.5q12
`
`2q12
`
`2.0
`1.0
`0
`-1.0
`-2.0
`-3.0
`-4.0
`
`Change From Baseline (mm2)
`
`CNV Size at baseline (mm2)
`
`4.6
`
`6.9
`
`4.8
`
`6.8
`
`Mandatory FA only; LOCF analysis; 0.5q4 and 0.5q12: n=32; 2q4, 2q12, and 4q12: n=31
`
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`Mean Change in Classic CNV Size
`by Fluorescein Angiography
`
`Fixed-dosing
`4
`
`0
`
`Week
`
`12
`
`PRN-dosing Phase
`24
`36
`
`48
`
`0.5q4
`1.2
`
`2q4
`1.2
`
`0.5q12
`1.8
`
`2q12
`1.8
`
`4q12
`1.3
`
`All P values ≤ 0.013
`
`0
`-0.2
`-0.4
`-0.6
`-0.8
`-1.0
`-1.2
`-1.4
`-1.6
`-1.8
`-2.0
`Classic CNV Size
`at Baseline (mm2)
`
`Change From Baseline (mm2)
`
`Mandatory FA only; LOCF analysis; 0.5q4 and 0.5q12: n=32; 2q4, 2q12, and 4q12: n=31
`
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`Safety: Serious Adverse Events
`
`Ocular Serious Adverse Events in the study eye:
`(cid:121) 1 case of culture-negative endophthalmitis / uveitis
`(deemed not related to study drug)
`Systemic Serious Adverse Events:
`(cid:121) None deemed to be drug-related
`(cid:121) 2 deaths
`– Pulmonary hypertension (pre-existing condition)
`– Pancreatic carcinoma
`(cid:121) Arterial Thromboembolic Events (ATE’s): 1 case of
`hemorrhagic stroke
`– Subject had a history of prior stroke
`
`26
`
`Mylan Exhibit 1055
`Mylan v. Regeneron, IPR2021-00881
`Page 26
`
`Joining Petitioner: Apotex
`
`
`
`Adverse Events
`(Study eye, all groups combined ≥ 5%)
`
`Adverse Event
`
`Conjunctival Hemorrhage
`Increased IOP (transient post-injection)
`Refraction Disorder
`Retinal Hemorrhage
`Visual Acuity Reduced (patient reported)
`Vitreous Detachment
`Eye Pain
`Vitreous Floaters
`
`Detachment of Retinal Pigment Epithelium
`
`Retinal Edema
`Visual Disturbance
`Blepharitis
`Cataract nuclear
`Subretinal Fibrosis
`IOP=intraocular pressure
`
`Number
`(N=157)
`60
`29
`25
`23
`21
`18
`15
`14
`
`12
`
`10
`9
`8
`8
`8
`
`Percent
`(%)
`38.2
`18.5
`15.9
`14.6
`13.4
`11.5
`9.6
`8.9
`
`7.6
`
`6.4
`5.7
`5.1
`5.1
`5.1
`
`27
`
`Mylan Exhibit 1055
`Mylan v. Regeneron, IPR2021-00881
`Page 27
`
`Joining Petitioner: Apotex
`
`
`
`Conclusions
`(cid:121) Patients received, on average, only two additional injections
`over 40-week PRN-dosing phase (after a 12-week fixed
`dosing period)
`– 19% received no additional injections after Week 12
`– 110 days median time to first re-injection
`(cid:121) VEGF Trap-Eye achieved clinically meaningful and durable
`vision improvement over 1 year
`– Up to +9.0 mean letters gained at week 52
`– Up to -161 microns reduction in central retinal lesion thickness at
`week 52 as measured by OCT
`(cid:121) Generally well tolerated with no drug-related serious
`adverse events
`– Most common AE’s typical of intravitreal injection
`
`28
`
`Mylan Exhibit 1055
`Mylan v. Regeneron, IPR2021-00881
`Page 28
`
`Joining Petitioner: Apotex
`
`
`
`VIEW 1 & VIEW 2 Phase 3 Studies
`(Dosing schedule-years 1 and 2)
`*
`36-51
`
`52
`
`52 – 96
`Capped PRN ‡
`
`Week
`
`0
`
`4
`
`8 12 16 20 24 28 32
`
`0.5 mg q4 wks
`
`2.0 mg q4 wks
`
`2.0 mg q8 wks†
`
`Ranibizumab
`0.5 mg q4 wks
`
`*Continued dosing at their respective intervals
`†After a loading dose period of 3-months
`‡ Capped PRN: minimum injection frequency is q12 weeks
`
`Primary and Secondary
`Endpoints Measured
`
`0.5 mg VEGF Trap
`
`2 mg q4 wks VEGF Trap
`
`2 mg q8 wks VEGF Trap
`
`0.5 mg Ranibizumab
`
`29
`
`Mylan Exhibit 1055
`Mylan v. Regeneron, IPR2021-00881
`Page 29
`
`Joining Petitioner: Apotex
`
`
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