`
`SESSION @ TREATMENT OF AMD 2005 Monday 10:30 am - 1:00 pm
`
`I2;29 pm
`Intravitreal Ranibizumab (Lucentis™) with
`Verteporfin Photodynamic Therapy for
`Neovascular Age-Related Macular
`Degeneration: Year One Results
`Jeffrey S. Heier, MD (Boston, MA)* FOCUS Study Group
`PURPOSE Lucentis™ (ranibizumab) is a humanized
`antibody fragment(Fab) that binds to and inactivates
`all active forms of VEGF. VEGF has been implicated in
`the pathogenesis of neovascular age-related macular
`degeneration (AMD).
`The primary objectives of the FOCUS study were to
`investigate the safety and tolerability of ranibizumab
`when administered as multiple intravitreal injections in
`combination with verteporfin photodynamic therapy
`(PDT), and to assess the effect of ranibizumab on visual
`loss from baseline.
`
`
`
`
`
`METHODS This was a Phase I/II, multicenter, single-
`masked, sham injection-controlled study ofintravitreally
`administered ranibizumab in subjects with primary or
`recurrent subfoveal choroidal neovascularization (CNV)
`secondary to AMD with investigator-determined pre-
`dominantly classic lesions. From April 2003 to January
`2004, participants were randomized in a 2:1 ratio to
`receive either 0.5 mg of ranibizumab or a sham injection
`monthly for 2 years in combination with PDT. Subjects
`received verteporfin PDT 7 days priorto thefirst admin-
`istration of study drug (ranibizumab or sham) and every
`3 months thereafter if deemed necessary by the inves-
`tigator and in accordance with product labeling. Study
`drug was held if a PDT treatment was administered
`within 1 week prior to scheduled injection.
`
`
`
`The primary safety and tolerability outcome measures
`are the incidence and severity of adverse events and the
`incidence of positive serum antibodiesto ranibizumab.
`The primary efficacy endpointis the proportion of
`subjects who at 12 months havelost <15 letters from
`baseline in best corrected visual acuity score assessed
`using an ETDRSchart.
`RESULTS Of 162 patients randomized (106 to ranibizumab,
`56 to sham injection), 76 (46.9%) were men and 86
`(53.1%) were women; 99% were Caucasian. Mean (SD)
`age was 74.1 (7.8) years (range, 50-93 years). At the time
`of abstract submission, 1-year results were not available,
`but will be presented at this meeting.
`
`CONCLUSION Thesafety,tolerability, and efficacy of
`ranibizumab administered as monthly intravitreal
`injections for 1 year in subjects in combination with
`verteporfin PDT in predominantly classic subfoveal
`
`neovascular AMDwill be reported.
`
`94 Scientific Paper Abstracts
`
`Exhibit 2100
`
`Page 01 of 01
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`
`12:36 pm
`OCT Imaging of Neovascular
`AMDPatients Treated with Ranibizumab
`(Lucentis”): The PrONTO Study
`Anne E. Fung, MD (Miami, FL)* Philip J. Rosenfeld, MD, PhD (Miami,
`FL)* Carmen A.Puliafito, MD (Miami, FL)* Stephan Michels, MD
`(Vienna, Austria)* Anna 5. Venkatraman, MS (Miami, FL)
`
`
`
`PURPOSE Ranibizumab (Lucentis™) is an anti-VEGF
`antibody fragment that binds andinhibitsall known
`biologically active isoforms andproteolytic fragments of
`vascular endothelial growth factor (VEGF). In PhaseI/II
`studies, monthly intravitreal injections of ranibizumab
`were well tolerated and associated with improvedvisual
`acuity (VA), decreased optical coherence tomography
`(OCT) central retinal thickness (CRT) measurements,
`and diminished or absentfluorescein angiographic
`leakage from choroidal neovascularization (CNV) in
`patients with age-related macular degeneration
`(AMD). PhaseIII trials with ranibizumab are currently
`underway. To determine the time-course and duration
`for the decrease in CRT and the improvement in VA
`following intravitreal injections of ranibizumab, we are
`performinga single-site, FDA-reviewed, investigator
`sponsoredtrial at the Bascom Palmer Eye Institute
`known as the Prospective OCT Imaging of Patients with
`
`Neovascular AMDTreated with Intra-Ocular Lucentis
`(PrONTO) Study.
`METHODS 40 AMDpatients with subfoveal CNV and OCT
`CRT measurements of at least 300 micronsare being
`enrolled in this prospective, open-label, uncontrolled
`clinical study. Each patient receives 3 consecutive
`monthly injections of ranibizumab (500 pg) in their
`study eye with subsequentinjections performed only
`if an increase in OCT CRTis observed. Duringthefirst
`2 months, OCT CRT measurements are obtained at
`baseline and on post-injection days 1, 2, 4, 7, 14, and 30.
`EDTRSvisual acuities are obtained at baseline and on
`post-injection days 14, 30, 45, 60, and 90.
`
`
`
`Exhibit 2100
`
`Mylan v. Regeneron
`IPR2021-00881
`U.S. Pat. 9,254,338
`
`* Financial interest disclosed
`
`
`
`Exhibit 2100
`Page 01 of 01
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