Predicting Aflibercept Local Exposure in Humans Using an Ocular PBPK Model

Authors: Le Merdy M, Li HY, Suen WLL, Lukacova V
Conference: AAPS
Keywords: AAPS 2025, gastroplus, humans, ocular PBPK, PBPK modeling
Software: GastroPlus®

Purpose

  • Developing both innovative and generic ophthalmic drug products remains a significant hurdle for the pharmaceutical industry.
  • Ocular physiologically based pharmacokinetic (O-PBPK) offer valuable insights into how drugs distribute across different eye tissues.
  • O-PBPK models is an alternative approach for studying the ocular pharmacokinetics and pharmacodynamics.
  • The utility of O-PBPK models has already been shown in predicting first-in-human doses for small molecule drugs.
  • This study aims to demonstrate how an O-PBPK model, validated using preclinical data, can be used to estimate clinical local exposure levels of aflibercept (AFL), a biologic therapy used in treating Neovascular Age-Related Macular Degeneration.

By Maxime Le Merdy, Ho Yin Li, Wai Leung Langston Suen, Viera Lukacova

American Association of Pharmaceutical Scientists (AAPS) PharmSci360, November 9-12, 2018, San Antonio, TX