`
`www.archive.org
`
`415.561.6767
`
`415.840-0391 e-fax
`
`
`
`Internet Archive
`
`300 Funston Avenue
`
`San Francisco, CA 94118
`
`_____________________
`
`AFFIDAVIT OF DUNCAN HALL
`
`
`
`1. I am a Records Request Processor at the Internet Archive, located in San Francisco,
`California. I make this declaration of my own personal knowledge.
`
`
`2. The Internet Archive is a website that provides access to a digital library of Internet
`sites and other cultural artifacts in digital form. Like a paper library, we provide
`free access to researchers, historians, scholars, and the general public. The Internet
`Archive has partnered with and receives support from various institutions,
`including the Library of Congress.
`
`
`3. The Internet Archive has created a service known as the Wayback Machine. The
`Wayback Machine makes it possible to browse more than 450 billion pages stored
`in the Internet Archive's web archive. Visitors to the Wayback Machine can search
`archives by URL (i.e., a website address). If archived records for a URL are
`available, the visitor will be presented with a display of available dates. The visitor
`may select one of those dates, and begin browsing an archived version of the Web.
`Links on archived files in the Wayback Machine point to other archived files
`(whether HTML pages or other file types), if any are found for the URL indicated
`by a given link. For instance, the Wayback Machine is designed such that when a
`visitor clicks on a hyperlink on an archived page that points to another URL, the
`visitor will be served the archived file found for the hyperlink’s URL with the
`closest available date to the initial file containing the hyperlink.
`
`
`4. The archived data made viewable and browseable by the Wayback Machine is
`obtained by use of web archiving software that automatically stores copies of files
`available via the Internet, each file preserved as it existed at a particular point in
`time.
`
`
`5. The Internet Archive assigns a URL on its site to the archived files in the format
`http://web.archive.org/web/[Year in yyyy][Month in mm][Day in dd][Time code in
`hh:mm:ss]/[Archived URL] aka an “extended URL”. Thus, the extended URL
`http://web.archive.org/web/19970126045828/http://www.archive.org/ would be the
`URL for the record of the Internet Archive home page HTML file
`(http://www.archive.org/) archived on January 26, 1997 at 4:58 a.m. and 28
`seconds (1997/01/26 at 04:58:28). A web browser may be set such that a printout
`from it will display the URL of a web page in the printout’s footer. The date
`indicated by an extended URL applies to a preserved instance of a file for a given
`URL, but not necessarily to any other files linked therein. Thus, in the case of a
`page constituted by a primary HTML file and other separate files (e.g., files with
`images, audio, multimedia, design elements, or other embedded content) linked
`within that primary HTML file, the primary HTML file and the other files will each
`have their own respective extended URLs and may not have been archived on the
`same dates.
`
`
`
`Mylan Exhibit 1070
`Mylan v. Regeneron, IPR2021-00881
`Page 1
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`6. Attached hereto as Exhibit A are true and accurate copies of printouts of
`screenshots of the Internet Archive's records of the archived files for the URLs and
`the dates specified in the attached coversheet of each printout.
`
`
`7. I declare under penalty of perjury that the foregoing is true and correct.
`
`
`
`
`
`
`
`
`DATE: ________________________
`
`
`________________________
`Duncan Hall
`
`01/20/2021
`
`Mylan Exhibit 1070
`Mylan v. Regeneron, IPR2021-00881
`Page 2
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`
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`EXHIBIT A
`EXHIBIT A
`
`Mylan Exhibit 1070
`Mylan v. Regeneron, |PR2021-00881
`Page 3
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`Mylan Exhibit 1070
`Mylan v. Regeneron, IPR2021-00881
`Page 3
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`https://web.archive.org/web/20110408231012/http://clinicaltrials.gov/ct2/show/NCT0101297
`3
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`Mylan Exhibit 1070
`Mylan v. Regeneron, IPR2021-00881
`Page 4
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`.._ n m. r
`-. u: u I \ II
`httpflclinicaltrialsgcvfctzjfshowaCTD1012923
`
`
`
`
`iauimllnmnmu __
`
`I
`
`II
`
`8 Apr 2-31; — 14 \Icv 20:3
`
`II
`
`II
`
`
`ClinicalTrifllS.gov
`Home Search Study Topics Glossary
`Assn-lice ofthe us. National Institutes of Health
`ll Search l
`
`
`FU" TEXT View
`
`Tabular View
`
`No Study Results Posted
`
`Related Studies
`
`Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Central Retinal Vein Occlusion
`{CRVO} (GALILEOj
`
`This study is ongoing, but not recruiting participants.
`First Received on October 30, 2009. Last Updated on January 25, 2011 History of Changfi
`
`
`
`F Purpose
`To determine the efficacy of vascular endothelial growth factor [VEGFj Trap-Eye injected into the eye on vision function in subjects with macular edema as a consequence of central retinal
`vein occlusion
`
`MM Ln» Retinal Vein Occlusion
`
`Drug: VEGF Trap—Eye (SAVES—5321)
`Other: Sham treatment
`
`Phase III
`
`lnterventional
`Study Type:
`Study Design: Allocation: Randomized
`Endpoint Classification: Safetnyfficacy Study
`Intervention Model: Parallel Assignment
`Masking: Double Blind (Subject. Investigator, Outcomes Assessor}
`Primary Purpose: Treatment
`
`Official Title:
`
`A Randomized. Double—masked. Sham—controlled Phase 3 Study of the Efficacy, Safety and Tolerability of Repeated Intravitreal Administration of VEGF Trap-Eye in
`Subjects With Macular Edema Secondary to Central Retinal Vein Occlusion (CRVO)
`
`Resource links provided by NLM:
`
`Genetics Home Reference related topics: Stargardt macular degeneration X-linked juvenile retinoschisis
`MedlinePlus related topics: Edema
`
`D_rug Information available for: Aflibercem
`US FDA Resources
`
`Further study delalls as provided by Bayer:
`
`Primary Outcome Measures:
`. The proportion of subjects who gain at least 15 letters in BCVA on the EDTRS chart compared with baseline at the Week 24 endpoint [ Time Frame: Week 24 ]
`[ Designated as safety issue: No]
`
`Secondary Outcome Measures:
`. Change from baseline in BCVA score [ Time Frame: week 24 ] [ Designated as safety issue: No]
`Absolute change from baseline in central retinal thickness. assessed by OCT [ Time Frame: Week 24 ] [ Designated as safety issue: No]
`Proportion of subjects progressing to anterior segment neovascularization, neovascularization of the optic disc two). or neovascularization of the retina elsewhere
`(NVEj requiring pan—retinal photocoagulation [Time Frame: Week 24] [ Designated as safety issue: No]
`Change in the NEl-VFO-25 total score from baseline [Time Frame: Week 24 ][ Designated as safety issue: No]
`Change in the EO-5D score from baseline [Time Frame: Week 24] [ Designated as safety issue: No]
`
`165
`Estimated Enrollment:
`October 2009
`Study Start Date:
`March 2012
`Estimated Study Completion Date:
`Estimated Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
`
`m Assigned Interventions
`Arm 1: Experimental
`Drug: VEGF Trap-Eye [BAY86-5321)
`Intervention:
`lntravitreal injection. Weeks 0 to 20 injection of VEGF Trap-Eye every 4 weeks; weeks 24 to 52 every 4 weeks plus additional on week 60
`Drug: VEGF
`and 68 re—assessment and either [PRNj injection of VEGF Trap-Eye or sham injection; last visit [no treatment) at week ?6.
`Trap-Eye
`(BAYSB—
`5321}
`Arm 2: Sham
`
`Other: Sham treatment
`
`treatment
`
`Comparator
`Intervention:
`Other: Sham
`
`Sham treatment. Weeks 0 to 2G sham treatment every 4 weeks; weeks 24 to 43 every 4 weeks re—assessment and sham injection; week
`52 VEGF Trap—Eye injection [unless investigator declines for medical reasons}. weeks 60 and Ba re-assessment and either [PRN)
`injection of VEGF Trap—Eye or sham injection; last visit {no treatment) at week 'r'S.
`
`Mylan Exhibit 1070
`Mylan v. Regeneron, |PR2021-00881
`Page 5
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`Mylan Exhibit 1070
`Mylan v. Regeneron, IPR2021-00881
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`b Eligibility
`Ages Eligible for Study:
`Genders Eligible for Study:
`Accepts Healthy Volunteers:
`Criteria
`Inclusion Criteria:
`
`18 Years and older
`Both
`No
`
`. Center—involved macular edema secondary to central retinal vein occlusion {CRUD} for no longer than 9 months with mean central subfield thickness >= 250 pm on optical
`coherence tomography {OCT}
`. Adults >=1B years
`. early treatment diabetic retinopathy study (ETDRS) best corrected visual acuity (BCVA) of 20.?40 to 20:32:] (its to 24 letters) in the study eye
`Exclusion Criteria:
`
`. Any prior treatment with anti—VEGF agents in the study eye {Pegaptanib sodium, aneco rtave acetate, bevacizumabI ranibizumabI etc_] or previous administration of
`systemic anti-angiogenic medications
`. Prior panretinal laser photocoagulati on or macular laser photocoagulation in the study eye
`. CRVO disease duration > 9 months trom date of diagnosis
`. Previous use of intraocular corticosteroids in the study eye or use of periocular corticosteroids in the study eye within the 3 months prior to Day 1
`.
`Iris neovascularization; vitreous hemorrhage, traction retinal detachment; or preretinal fibrosis involving the macula in either the study eye or fellow eye
`
`D Contacts and Locations
`
`Please refer to this study by its ClinicalTrials.gov identifier: NCT010129?3
`
`fl Show 73 Study Locations
`
`Sponsors and Collaborators
`Bayer
`Regeneron Pharmaceuticals
`
`Investigators
`Study Director: BayerStudy Director Bayer
`
`F More Information
`Additional Information:
`
`Click here and search tor drug information provided by the FDA. fl
`
`Click here and search tor intormation on any recalls market or product safety alerts by the FDA which might have occurred with this product. M
`
`Click here to find results tor studies related to marketed products. w
`
`No publications provided
`
`Bayer HealthCare AG {Therapeutic Area Head )
`Responsible Party:
`ClinicalTrials_gov Identitier: NCT010129?3
`History of Changfi
`Other Study ID Numbers:
`14130, EudraCT: 2009—0109?3—19
`Study First Received:
`October 30, 2009
`Last Updated:
`January 25, 2011
`Health Authority:
`Germany: Federal Institute for Drugs and Medical Devices; Australia: Department of Health and Ageing Therapeutic Goods Administration; Austria: Agency
`for Health and Food Safety: France: Afssaps — French Health Products Safety Agency; Hungary: National Institute ot Pharmacy;
`Italy: Ministry at Health;
`Latvia: State Agency ot Medicines;
`Japan: Pharmaceuticals and Medical Devices Agency: Singapore: Health Sciences Authority: South Korea: Korea Food
`and Drug Administration {KFDA}
`
`Keywords provided by Bayer:
`Macular Edema
`Central Retinal Vein Occlusion
`CRVO
`VEG F Trap—Eye
`best-corrected visual acuity
`Additional relevant MeSH terms:
`Macular Edema
`Retinal Vein Occlusion
`Macular Degeneration
`Retinal Degeneration
`Retinal Diseases
`Eye Diseases
`Venous Thrombosis
`Thrombosis
`
`Embolism and Thrombosis
`Vascular Diseases
`Cardiovascular Diseases
`Endothelial Growth Factors
`Growth Substances
`Physiological Effects of Drugs
`Pharmacologic Actions
`
`ClinicalTrials_gov processed this record on April 0?. 2011
`
`
`coniact Help Desk
`LISICI HI” NaIIOI'IEII CONE” TOY BIDITIDUICEII communications. US. National LINE“!I 0‘ MEDICINE.
`us. Naiionai lnsiliutcs m Health. 0.5. Department or Health a Human services.
`usagov Gomgni. anacy. Accessibility. Freedom ct Imcrmatlon Act
`
`£32£3
`‘—
`Gemg“ NLM ..'U.5. Depanmcnt 01' Health 3n Human SGWICBS
`
`Mylan Exhibit 1070
`Mylan v. Regeneron, |PR2021-00881
`Page 6
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`Mylan Exhibit 1070
`Mylan v. Regeneron, IPR2021-00881
`Page 6
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`https://web.archive.org/web/20090813064936/https://clinicaltrials.gov/ct2/show/NCT006373
`77
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`Mylan v. Regeneron, IPR2021-00881
`Page 7
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`.._ n m. r
`
`-. u: u I \ II
`
`Illillllllllllllllllll
`
`
`
`httpsgffclinicaltrialsgovfctflshowfNCT0063?3??
`
`
`
`
`21_cmu_
`
`ZEJan 200'} - 231m 20 L?
`
`ClinicalTrialsgov
`A service of the U.S. National Institutes of Health
`
`
`Fun TEXT View
`
`Tabular View
`
`No Study Results Posted
`
`Related Studies
`
`
`Home Search
`study Topics Glossary
`
`H Search I
`
`Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Wet Age-Related Macular
`Degeneration (AMD) (VIEW 2)
`
`This study is currently recruiting participants.
`Verified by Bayer, .July 2009
`
`First Received: March 12. 2003 Last Updated: July 3, 2009 History of Changfi
`
`
`
`F Purpose
`This study is a phase III. double—masked. randomized. study of the efficacy and safety of VEGF Trap—Eye in patients with neovascular age—related macular degeneration. Approximately
`1200 patients will be randomized in Europe. Asia. Japan, Australia and South America.
`
`Mm— Macular Degeneration
`
`Drug: VEGF Trap—Eye
`Drug: Ranibizumab
`
`Phase III
`
`lnterventional
`Study Type:
`Study Design: Treatment. Randomized, Double Blind (Subject, Caregiver, Investigator. Outcomes Assessor), Active Control. Parallel Assignment. Safetyi'Efficacy Study
`
`Official Title:
`
`A Randomized. Double Masked, Active Controlled, Phase 3 Study of the Efficacy, Safety, and Tolerability of Repeated Doses of lntravitreal VEGF Trap in Subjects With
`NeovascularAge-Related Macular Degeneration {AMDL
`
`Resource links provided by NLM:
`
`Genetics Home Reference related topics: X-linked juvenile retinoschisis
`
`MedlinePlus related topics: Macular Degeneration
`
`D_rug Information available for: Ranibizumab Aflibercem
`US FDA Resources
`
`Further study delalls as provided by Bayer:
`
`Primary Outcome Measures:
`. The proportion of subjects who maintain vision at Week 52. where a subject is classified as maintaining vision if the subject has lost fewer than 15 letters on the ETDRS
`chart compared to baseline fie. prevention of moderate vision loss) [ Time Frame: week 52 ] [ Designated as safety issue: Yes ]
`
`Secondary Outcome Measures:
`. Mean change from baseline in BCVA as measured by ETDRS letter score at Week 52 [Time Frame: week 52] [ Designated as safety issue: Yes]
`. The proportion of subjects who gain at least 15 letters of vision at Week 52 [ TIme Frame: week 52] [ Designated as safety issue: No]
`. Mean change from baseline in total NEI UFO—25 score at Week 52 [Time Frame: week 52] [ Designated as safety issue: No ]
`. Mean change from baseline in CN\.Ir area at Week 52 [ TIme Frame: week 52] [ Designated as safety issue: Yes ]
`
`Estimated Enrollment:
`Study Start Date:
`Estimated Study Completion Date:
`Estimated Primary Completion Date:
`
`1200
`April 2008
`September 2011
`July 2011 (Final data collection date for primary outcome measure)
`
`L Assigned Interventions
`Arm 3:
`Drug: VEGF Trap-Eye
`Experimental
`2.0 mg VEGF Trap-Eye administered every 8 weeks [including one additional 2.0 mg dose at Week 4} during the first year. Thereafter a dose may be
`administered as frequently as every 4 weeks. but no less frequently than every 12 weeks.
`
`Arm 1:
`Experimental
`
`Arm 2:
`Experimental
`
`Drug: VEGF Trap-Eye
`0.5 mg VEGF Trap-Eye administered every 4 weeks during the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but
`no less frequently than every 12 weeks.
`
`Drug: VEGF Trap-Eye
`2.0 mg VEGF Trap-Eye administered every 4 weeks during the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but
`no less frequently than every 12 weeks.
`
`frequently than every 12 weeks.
`
`Arm 4:Active
`Comparator
`
`Drug: Ranibizumab
`0.5 mg administered every 4 weeks during the first year. Thereafter a dose may be administered as frequently as every 4 weeks. but no less
`
`b Eligibility
`
`Mylan Exhibit 1070
`Mylan v. Regeneron, lPR2021-00881
`Page 8
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`Mylan Exhibit 1070
`Mylan v. Regeneron, IPR2021-00881
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`Ages Eligible for Study:
`Genders Eligible for Study:
`Accepts Healthy Volunteers:
`Criteria
`
`50 Years and older
`Both
`No
`
`Inclusion Criteria:
`. Signed intormed consent.
`. Men and women >I=50 years ot age.
`. Active primary or recurrent subfoveal CNV lesions secondary to AMD. including juxtafoveal lesions that attect the fovea as evidenced by FA in the study eye.
`. ETDRS best-corrected visual acuity of: 20MB to 201820 [letter score ot ?a to 25) in the study eye at 4 meters.
`. Willing, committed. and able to return tor ALL clinic visits and complete all study—related procedures.
`. Able to read. (or. if unable to read due to visual impairment. be read to verbatim by the person administering the informed consent or a family member] understand and
`willing to sign the informed consent form.
`Exclusion Criteria:
`
`. Any prior ocular [in the study eye] or systemic treatment or surgery for neovascular AMD. except dietary supplements or vitamins.
`. Any prior or concomitant therapy with another investigational agent to treat neovascularAMD in the study eye.
`. Any prior treatment with anti—VEGF agents in the study eye.
`. Total lesion size >12 disc areas (30.5 mm&#xiffd;. including blood. scars and neovascularization} as assessed by FA in the study eye.
`. Subretinal hemorrhages that is either 50% or more of the total lesion area. or if the blood is under the fovea and is 1 or more disc areas in size in the study eye [it the blood
`is under the fovea, then the tovea must be surrounded by 2?0 degrees by visible CNV).
`. Scar or fibrosis making up >50‘3’u ot the total lesion in the study eye.
`. Scar_. tibrosis. or atrophy involving the center of the fovea in the study eye.
`. Presence of retinal pigment epithelial tears or rips involving the macula in the study eye.
`. History ot any vitreous hemorrhage within 4 weeks prior to Visit 1 in the study eye.
`. Presence of other causes ot CNV in the study eye.
`. Prior vitrectomy in the study eye.
`. History ot retinal detachment or treatment or surgery for retinal detachment in the study eye.
`. Any history ot macular hole of stage 2 and above in the study eye.
`. Any intraocular or periocular surgery within 3 months ot Day 1 on the study eye. except lid surgery. which may not have taken place within 1 month ot Day 1, as long as it is
`unlikely to interfere with the injection.
`. History or clinical evidence of diabetic retinopathy. diabetic macular edema or any retinal vascular disease other than AMD in either eye.
`
`> Contacts and Locations
`
`Please refer to this study by its ClinicalTrials.gov identifier: NCTOOBSTGW
`
`Contacts
`
`Contact: Bayer Clinical Trials Contact
`
`
`clinical—trials—contact@bayerheaithcare.com
`
`fl Show 212 Study Locations
`Sponsors and Collaborators
`Bayer
`
`Investigators
`Study Director: Bayer Study Director Bayer
`
`F More Information
`Additional Information:
`
`Click here and search tor drug information provided by the FDA fl
`
`Click here and search tor intormation on any recalls market or product safety alerts by the FDA which might have occurred with this product fl
`
`Click here to find results tor studies related to marketed products w
`
`No publications provided
`
`Bayer Schering Pharma AG (Therapeutic Area Head }
`Responsible Party:
`91689, EurdaCT No.1 2007-000583—25
`Study ID Numbers:
`March 12, 2008
`Study First Received:
`July 3. 2009
`Last Updated:
`History of Changfi
`ClinicalTrials.gov ldentitier: NCTDOSSTBT?
`Health Authority:
`Switzerland: Ethikkommission
`
`Keywords provided by Bayer:
`Eye diseases
`Vision Impairment and Blindness
`Eyes and Vision
`
`Seniors
`NeovascularAge-Related Macular Degeneration {AMD}
`Retinal Disease
`
`Study placed in the tollowing topic categories:
`Eye Diseases
`Mitogens
`Retinal Degeneration
`Macular Degeneration
`Additional relevant MeSH terms:
`Growth Substances
`Macular Degeneration
`Eye Diseases
`Endothelial Growth Factors
`Physiological Effects of Drugs
`Pharmacologic Actions
`Retinal Degeneration
`Retinal Diseases
`ClinicalTrials.gov processed this record on August 12, 2009
`CDnIflC‘I Help DESK
`LISICI HI” NEIIOI'IEII CCHICI TOY BIDITIDGICEII CDITII'flUI'IICalIDI'IS. Us. National Library 0‘ MEDICINE.
`U.S. National Institutes of Health. US. moment of Health & Human Sermons.
`
`Blindness
`Endothelial Growth Factors
`Retinal Diseases
`Vision, Low
`
`Mylan Exhibit 1070
`Mylan v. Regeneron, IPR2021-00881
`Page 9
`
`Mylan Exhibit 1070
`Mylan v. Regeneron, IPR2021-00881
`Page 9
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`

`

`
`USAgmr comgn: anacy. ACCESS-IDIIIIY. Freedom mlmormanonnct
`
`
`
`Mylan Exhibit 1070
`Mylan v. Regeneron, |PR2021-00881
`Page 10
`
`Mylan Exhibit 1070
`Mylan v. Regeneron, IPR2021-00881
`Page 10
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`

`

`https://web.archive.org/web/20090911163626/https://clinicaltrials.gov/ct2/show/NCT005097
`95
`
`
`Mylan Exhibit 1070
`Mylan v. Regeneron, IPR2021-00881
`Page 11
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`

`

`i-. n k‘-| r
`
`-. u: u | \ II
`
`Illllllllllllllllllllll
`
`
`
`httpswclinicaltrialsgovfthfshowfNCTOOSDQFSS
`
`
`
`
`21_cmu_
`1 Dec 26-05 — 23 Sec 2020
`
`
`
`
`ClinicalTrifllS.gov
`Home Search
`study Topics Glossary:
`Iservice ofthe us. National Institutes of Health
`[I Search I
`
`
`FU" TEXT View
`
`Tabular View
`
`No Study Results Posted
`
`Related Studies
`
`Vascular Endothelial Growth Factor(VEG F)Trap-Eye:lnvestigation of Efficacy and Safety in Wet Age-Related Macular
`Degeneraticn(AMD) (VIEW 1)
`
`This study is currently recruiting participants.
`Verified by Regeneron Pharmaceuticals. April 2009
`
`First Received: July 31. 200? Last Updated:April 28. 2009 History of Changfi
`
`Regeneron Pharmaceuticals
`
`F Purpose
`This study is a phase III. double—masked. randomized. study of the efficacy and safety of VEGF Trap—Eye in patients with neovascular age—related macular degeneration. Approximately
`1200 patients will be randomized in the US and Canada.
`
`Mm—
`Macular Degeneration
`Drug: VEGF Trap—Eye
`Phase III
`Drug: Ranibizumab
`
`
`
`lnterventional
`Study Type:
`Study Design: Treatment. Randomized. Double Blind (Subject, Caregiver. Investigator. Outcomes Assessor). Active Control. Parallel Assignment. Safetyi'Efficacy Study
`
`Official Title:
`
`A Randomized. Double Masked. Active Controlled Phase III Study of the Efficacy, Safety, and Tolerability of Repeated Doses of lntravitreal VEGF Trap in Subjects With
`NeovascularAge-Related Macular Degeneration
`
`Resource links provided by NLM:
`
`Genetics Home Reference related topics: X-linked juvenile retinoschisis
`
`MedlinePlus related topics: Macular Degeneration
`
`D_rug Information available for: Ranibizumab Aflibercem
`US FDA Resources
`
`Further study details as provided by Regeneron Pharmaceuticals:
`
`Primary Outcome Measures:
`. The proportion of subjects who maintain vision at Week 52. where a subject is classified as maintaining vision if the subject has lost fewer than 15 letters on the ETDRS
`chart compared to baseline {i.e. prevention of moderate vision loss} [Time Frame: Week 52 ][ Designated as safety issue: Yes ]
`
`Secondary Outcome Measures:
`. Mean change from baseline in BCVA as measured by ETDRS letter score at Week 52 [Time Frame: Week 52] [ Designated as safety issue: Yes ]
`. The proportion of subjects who gain at least 15 letters of vision at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No]
`. Mean change from baseline in total NEI UFO—25 score at Week 52 [Time Frame: Week 52] [ Designated as safety issue: No]
`. Mean change from baseline in CNV area at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: Yes ]
`
`1200
`Estimated Enrollment:
`August 2007
`Study Start Date:
`December 2011
`Estimated Study Completion Date:
`Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
`
`Assigned Interventions
`
`1:
`Experimental
`
`Drug: VEGF Trap-Eye
`0.5 mg VEGF Trap-Eye administered every 4 weeks during the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but
`no less frequently than every 12 weeks.
`
`than every 12 weeks.
`
`.
`Experimental
`
`Drug: VEGF Trap-Eye
`2.0 mg VEGF Trap-Eye administered every 4 weeks during the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but
`no less frequently than every 12 weeks.
`
`.
`Experimental
`
`Drug: VEGF Trap-Eye
`2.0 mg VEGFTrap-Eye administered every 8 weeks [including one additional 2.0 mg dose at week 4) during the first year. Thereafter a dose may be
`administered as frequently as every 4 weeks. but no less frequently than every 12 weeks.
`
`4: Active
`Comparator
`
`Drug: Ranibizumab
`0.5 mg administered every 4 weeks during the first year. Thereafter a dose may be administered as frequently as every 4 weeks. but no less frequently
`
`Mylan Exhibit 1070
`Mylan v. Regeneron, lPR2021-00881
`Page 12
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`Mylan Exhibit 1070
`Mylan v. Regeneron, IPR2021-00881
`Page 12
`
`

`

`' Eligibility
`
`Ages Eligible for Study:
`Genders Eligible for Study:
`Accepts Healthy Volunteers:
`Criteria
`
`lder
`
`50 Years and o
`Both
`No
`
`Key Inclusion Criteria:
`1. Signed Informed Consent.
`Men and women 2 50 years ot age.
`Active primary or recurrent subfoyeal CNV lesions secondary to AMD. including juxtafoyeal lesions that attect the foyea as eyid enced by FA in the study eye.
`ETDRS best-corrected visual acuity of: 20MB to 203320 [letter score ot 1’3 to 25) in the study eye.
`Willing, committed. and able to retu
`rn tor ALL clinic visits and complete all study—related procedures.
`Able to read. (or. if unable to read due to visual impairment. be read to verbatim by the person administering the informed consent or a family member. See Appendix J.4}
`understand and willing to sign the informed consent form.
`
`FENP'Q’N
`
`sheets—-
`99:4?“ Presence of retinal pigment epitheli
`
`Key Exclusion Criteria:
`. Any prior ocular [in the study eye] or systemic treatment or surgery for neoyascular AMD except dietary supplements or vitamins.
`Any prior or concomitant therapy with another investig ational agent to treat neoyascular AMD in the study eye. except dietary supplements or vitamins.
`Any prior treatment with anti—VEGF
`agents in the study eye.
`Total lesion size > 12 disc areas {30.5 mm2. including blood. scars and neoyascularization) as assessed by FA in the study eye.
`Subretinal hemorrhage that is either 50% or more of the total lesion area, or if the blood is under the fovea and is 1 or more disc areas in size in the study eye. (If the blood
`is under the foyea, then the tovea must be surrounded 2?!) degrees by visible CNV.)
`Scar or fibrosis. making up > 50% of total lesion in the study eye.
`Scar. tibrosis. or atrophy involving the center of the foyea.
`al tears or rips involving the macula in the study eye.
`within 4 weeks prior to Visit 1 in the study eye.
`9. History at any vitreous hemorrhage
`10. Presence of other causes ot CNV in the study eye.
`11. History or clinical evidence of diabetic retinopathy. diabetic macular edema or any other vascular disease affecting the retina.other than AMD. in either eye.
`12. Prior vitrectomy in the study eye.
`13. History at retinal detachment or treatment or surgery for retinal detachment in the study eye.
`14. Any history ot macular hole of stage 2 and above in the study eye.
`15. Any intraocular or periocular surgery within 3 months ot Day 1 on the study eye. except lid surgery. which may not have taken place within 1 month ot day 1, as long as its
`unlikely to interfere with the injection.
`
`> Contacts and Locations
`
`Please refer to this study by its ClinicalTrials.gov identifier: NCT00509?95
`
`Contacts
`
`Contact: Regeneron
`
`866—549-3439 VlEW1study®rtp.ppdi.com
`
`fl Show 191 Study Locations
`Sponsors and Collaborators
`Regeneron Pharmaceuticals
`Bayer
`
`Investigators
`Study Director: Avner lngerman, MD Regeneron Pharmaceuticals
`
`> More Information
`
`No publications provided
`
`Regeneron Pharmaceuticals [ Dr. Ayner lngerman ]
`Responsible Party:
`VGFT—OD—0605
`Study ID Numbers:
`July 31, 200?
`Study First Received:
`April 28. 2009
`Last Updated:
`History of Changfi
`ClinicalTrialsgov ld entitier: NCT00509795
`Health Authority:
`United States: Food and Drug Administration: Canada: Health Canada
`
`Study placed in the tollowing topic categories:
`Eye Diseases
`Mitogens
`Retinal Degeneration
`Additional releyant MeSH terms:
`Growth Substances
`Eye Diseases
`Physiological Effects of Drugs
`Retinal Degeneration
`
`Macular Degeneration
`Endothelial Growth Factors
`Retinal Diseases
`
`Macular Degeneration
`Endothelial Growth Factors
`Pharmacologic Actions
`Retinal Diseases
`
`tember 11 _. 2009
`ClinicalTrialsgov processed this record on Sep
`
`
`Conlac‘t Help Desk
`LIsrcr Hlll Nallcnal ccnlcr tor Biomedical communications. 0.5. National Library or Medicine.
`U.S. National Il'lSlIlUIDS at Health. US. Dcpar‘n'ncnt of Health &. Human Sermons.
`USAgW ccmgnl. anacy. Accessmlllty. Freedom ct Intcrmatlcn Act
`
`E3
`dun-u.
`ewe NLM %
`
`Mylan Exhibit 1070
`Mylan v. Regeneron, lPR2021-00881
`Page 13
`
`Mylan Exhibit 1070
`Mylan v. Regeneron, IPR2021-00881
`Page 13
`
`

`

` JURAT
`
`State/Commonwealth of _____________________
`
` City County of ______________________
`
`)
`)
`)
`
`On __________________, before me, _________________________________________ ,
`Date
`Notary Name
` the foregoing instrument was subscribed and sworn (or affirmed) before me by:
`
`________________________________________________________________________.
`Name of Affiant(s)
`
` Personally known to me -- OR --
`
` Proved to me on the basis of the oath of _____________________________ -- OR --
`Name of Credible Witness
` Proved to me on the basis of satisfactory evidence: ________________________________
`Type of ID Presented
`
`WITNESS my hand and official seal.
`
`Notary Public Signature: _________________________
`
`Notary Name:__________________________________
`Notary Commission Number:______________________
`Notary Commission Expires:______________________
`Notarized online using audio-video communication
`
`DESCRIPTION OF ATTACHED DOCUMENT
`
`Title or Type of Document: ____________________________________________________
`
`Document Date: ________________________________
`
`Number of Pages (including notarial certificate): _____________
`
`VIRGINIA
`
`Virginia Beach
`
`01/20/2021
`
`William Scott
`
`Duncan D Hall
`
`driver_license
`
`William Scott
`7897791
`01/31/2024
`
`Affidavit of Authenticity
`
`01/20/2021
`
`14
`
`Mylan Exhibit 1070
`Mylan v. Regeneron, IPR2021-00881
`Page 14
`
`