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`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)
`
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`
`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.
`
`Samsung et al. v. Regeneron IPR2023-00884
`Regeneron Pharmaceuticals, Inc. Exhibit 2080 Page 1
`
`

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`Reviewing Codes (Complete): 183 diabetic retinopathy: clinical research – RE
`Presentation Preference (Complete): &nbspPaper #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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`
`Samsung et al. v. Regeneron IPR2023-00884
`Regeneron Pharmaceuticals, Inc. Exhibit 2080 Page 2
`
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