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<p>A clinical development program for follow-on locally acting intravitreal drug products typically includes a comparative efficacy study. Pharmacokinetic assessment is often considered of limited value because systemic exposure is low and/or not predictive of efficacy at the site of action. In this commentary, we evaluated the relevance of pharmacokinetics for locally acting intravitreal large molecule drug products. Our assessment showed that systemic pharmacokinetic information including the rate constant could provide valuable insights into estimating local exposure of intravitreally administered drugs. This information has the potential to introduce a novel approach to clinical development programs for follow-on locally acting intravitreal drug products.</p>

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Novel Pharmacokinetic Bridging Strategy for Locally Acting Intravitreal Drug Products

  • 期刊论文

  • 发表日期：

    2025年8月11日

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  • Ping Ji,
  • William M. Boyd,
  • Chandrahas Sahajwalla

摘要

A clinical development program for follow-on locally acting intravitreal drug products typically includes a comparative efficacy study. Pharmacokinetic assessment is often considered of limited value because systemic exposure is low and/or not predictive of efficacy at the site of action. In this commentary, we evaluated the relevance of pharmacokinetics for locally acting intravitreal large molecule drug products. Our assessment showed that systemic pharmacokinetic information including the rate constant could provide valuable insights into estimating local exposure of intravitreally administered drugs. This information has the potential to introduce a novel approach to clinical development programs for follow-on locally acting intravitreal drug products.