アステラス製薬株式会社

アステラス製薬株式会社

IZERVAY Online Meeting

2023年11月6日

Iveric Bio Senior Vice President and Chief Development Officer
Dhaval Desai
Iveric Bio Vice President, Product Strategy and Innovation
Erin Henry
Vice President, Head of Cell & Gene Therapy Development
Carolyn Sasse

再生リスト

最初から再生

Investor call:
IZERVAY (AVACINCAPTAD PEGOL intravitreal solution)
GATHER2 2-YEAR data Presented at AAO 2023
  • Cautionary Statement Regarding Forward-Looking Information
DHAVAL DESAI
Today’s presentation contents
AAO Update AND GATHER2 Summary and background
  • AAO Update
  • Summary of gather2: 2-year data
  • IZERVAY is designed to be a specific inhibitor of complement C5
  • IZERVAY ACHIEVED THE 12-MONTH PRESPECIFIED PRIMARY OBJECTIVE IN 2 PIVOTAL PHASE 3 STUDIES
  • GATHER2 is a 2-year, phase 3, international, multicenter, prospective, randomized, double-masked, sham-controlled study (NCT04435366)
GATHER2 2-YEAR DATA
  • IZERVAY reduced GA growth when dosed EM AND EOM vs sham
  • Treatment effect more than doubled with IZERVAY over 2 years compared to 1 year
  • No statistically significant difference in 15-letter persistent vision loss between IZERVAY and sham
  • Treatment emergent adverse events (TEAEs) over 2 years were similar and consistent with year 1
  • Serious ocular TEAEs - No new safety signals in year 2
  • Choroidal neovascularization (CNV)
  • Adverse events of special interest
  • Summary of gather2: 2-year data
  • LIFECYCLE MANAGEMENT UPDATE
Questions
  • Questions 1
  • Questions 2
  • Questions 3
  • Questions 4
  • Questions 5
  • Questions 6
  • 前へ
  • 次へ

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