`Dave Brown
`"Deneva Zamora"
`FW: ARVO late breakers
`Monday, March 1, 2010 4:09:00 PM
`ARVO DRAFT VEGF Trap-EYe DME abstract 022610.doc
`
`From:
`To:
`Cc:
`Subject:
`Date:
`Attachments:
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`Dave,
`
`Any thoughts about the abstract?
`
`Thanks,
`Alyson
`
`From: Alyson Berliner
`Sent: Friday, February 26, 2010 3:54 PM
`To: Dave Brown
`Subject: RE: ARVO late breakers
`
`OK. If you think it will work…. Thanks!! I guess if it doesn’t, could Matt be a back up?
`
`I am attaching a draft of the abstract. Let me know what you think. We can finalize on Monday.
`
`Thanks and have a great weekend!
`Alyson
`
`From: Dave Brown [mailto:dmbmd@houstonretina.com]
`Sent: Friday, February 26, 2010 9:59 AM
`To: Alyson Berliner
`Subject: Re: ARVO late breakers
`
`Its probably fine but what is your back-up plan?
`
`I logged in and it allows my ARVO number to be used. The check boxes that “I affirm” don’t ask the
`previous submission question.
`
`Its up to you.-- I’d love to present it but its remotely possible they will check after the fact.
`
`DMB
`
`On 2/26/10 7:52 AM, "Alyson Berliner" <Alyson.Berliner@regeneron.com> wrote:
`
`Hi Dave! Thanks… I was looking on the ARVO website for the submission guidelines and found this
`statement: Late-Breaking Abstracts may be submitted only by a First Author who did not previously
`submit an abstract for the 2010 ARVO Annual Meeting. (http://www.arvo.org/eweb/dynamicpage.aspx?
`site=am2010&WebCode=absubmissionguide)
`
`Do you think it’s still OK if you submit? Is there any way we can find out for sure?
`
`Regeneron Pharmaceuticals, Inc. Exhibit 2021 Page 1
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc. IPR2023-00884
`
`
`
`Thanks!
`Alyson
`
`
`From: Dave Brown [mailto:dmbmd@houstonretina.com]
`Sent: Thursday, February 25, 2010 7:45 PM
`To: Alyson Berliner
`Subject: Re: ARVO late breakers
`Importance: High
`
`Sure-- I’m you’re boy. Because I was nuked-- I’m still fair game.
`
`DMB
`
`On 2/25/10 4:14 PM, "Alyson Berliner" <Alyson.Berliner@regeneron.com> wrote:
`Hi Dave,
`
`How are you? Hope all is well…
`
`We are trying to find someone interested in submitting the DA VINCI data as a late breaker to ARVO
`(abstract due next Wednesday). The only problem is, it has to be someone that has not submitted
`anything already. I know you submitted the VIEW 1 abstract, but I am not sure that counts as it wasn’t
`accepted. If you aren’t already presenting something else, would you be interested? Or maybe Matt?
`
`Thanks,
`Alyson
`
`
`
`Alyson J Berliner, MD,PhD
`Director, Clinical Sciences, Ophthalmology
`Regeneron Pharmaceuticals
`(914) 785-3049 (office)
`(914) 815-8875 (mobile)
`(914) 593-1555 (fax)
`Alyson.Berliner@regeneron.com
`
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`Regeneron Pharmaceuticals, Inc. Exhibit 2021 Page 2
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc. IPR2023-00884
`
`
`
`mail and of any such attachment, and any printout thereof. Finally, please note that only authorized
`representatives of Regeneron Pharmaceuticals, Inc. have the power and authority to enter into
`business dealings with any third party.
`
`Regeneron Pharmaceuticals, Inc. Exhibit 2021 Page 3
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc. IPR2023-00884
`
`
`
` Print this Page for Your Records
`Control/Tracking Number: 10-LB-8576-ARVO
`Activity: Late Breaker
`Current Date/Time: 3/3/2010 12:41:32 PM
`DA VINCI: DME And VEGF Trap-Eye: INvestigation of Clinical Impact: Phase 2 study in patients
`with Diabetic Macular Edema (DME)
`
`Close Window
`
`Author Block: J.C. Major, Jr., D.M. Brown, DA VINCI Study Group. Retina Consultants of Houston,
`Houston, TX.
`Abstract: PURPOSE
`VEGF Trap-Eye (VTE) is a recombinant fusion protein consisting of VEGF binding domains of human VEGF
`receptors 1 and 2 fused to the Fc domain of human IgG1. This phase 2 study assesses the efficacy and safety
`of intravitreal VTE vs. laser photocoagulation in DME at the 24-week primary endpoint.
`METHODS
`DA VINCI is a multi-center, randomized, active-controlled Phase 2 clinical study, designed to assess safety
`and efficacy of 4 dose/dose intervals of VTE in comparison to laser photocoagulation. 221 patients were
`randomized (219 treated) to 1 of the following treatment arms: 0.5mg q4wks, 2mg q4wks, 2mg q8wks, 2mg
`prn or laser photocoagulation. The primary endpoint is the mean change from baseline in BCVA at week 24.
`Secondary endpoints include changes in retinal thickness (CRT) on OCT and central retinal sensitivity. Central
`retinal sensitivity was measured using the Nidek MP-1 microperimeter with values corresponding to the OCT
`central subfield.
`RESULTS
`At 6 months, the mean change in BCVA for each VTE arm ranged from +8.5 to +11.4 letters and was
`statistically significantly better than the mean change in BCVA in the laser arm (+2.5 letters; p<0.01). No
`significant difference was noted among the VTE arms. Anatomical effects (mean change in CRT) for each
`VTE arm ranged from -127μm to -195μm and were significantly greater than the mean change in CRT for the
`laser arm (-68μm; p<0.01). VTE arms had a mean gain in central retinal sensitivity ranging from 1.5 to 4.1dB,
`while the laser arm had a mean decrease of -0.4dB. VTE was generally well-tolerated, and adverse events
`(AEs) reported were those typically associated with intravitreal injections or underlying disease. There were
`two cases of endophthalmitis, one culture negative and one positive for Staphylococcus epidermidis. The most
`frequent AEs reported in the VTE arm include conjunctival hemorrhage, eye pain, floaters, ocular hyperemia,
`and increased IOP.
`CONCLUSION
`In this patient population at the 24-week primary endpoint, intravitreal VTE was generally well tolerated and
`produced significant improvements from baseline in visual acuity and retinal thickness and a trend toward
`improvement in central retinal sensitivity as compared to laser photocoagulation.
`:
`Author Disclosure Information: J.C. Major, Jr., Alcon, Alimera, Allergan, CoMentis, Genentech, Jerini,
`NeoVista, Neurotech, Novartis, Othera, Oxigene, Pfizer, Regeneron; D.M. Brown, alcon, Alimera, Allergan,
`CoMentis, Genentech, Jerini, NeoVista, Neurotech, Novartis, Othera, Oxigene, Pfizer, Regeneron; alcon,
`Allergan, Carl Zeiss Meditec, Genentech, Heidelberg Engineering, Molecular Partners, NeoVista, Novartis,
`Oraya,Regeneron, Steba.
`
`Regeneron Pharmaceuticals, Inc. Exhibit 2021 Page 4
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc. IPR2023-00884
`
`
`
`Reviewing Codes (Complete): 183 diabetic retinopathy: clinical research – RE
`Presentation Preference (Complete):  Paper #1, Poster #2
`Keyword (Complete): 499 diabetic retinopathy ; 466 clinical (human) or epidemiologic studies:
`treatment/prevention assessment/controlled clinical trials ; 744 vascular endothelial growth factor
`Clinical Trial, Newsworthy, & Eligibility (Complete):
`*Does the study meet the definition of a clinical trial?: Yes
`: www.clinicaltrials.gov NCT00789477
`*Newsworthy: Yes
`Public : True
`Researchers in Other Disciplines : True
`Clinicians : True
`* Eligibility Statement : Data not available for primary endpoint (24 week) until February 2010
`
`Support (Complete):
`*Support : None
`
`Status: Complete
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`Regeneron Pharmaceuticals, Inc. Exhibit 2021 Page 5
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc. IPR2023-00884
`
`