June 2020
Volume 61, Issue 7
Free
ARVO Annual Meeting Abstract  |   June 2020
Nonclinical toxicology and biocompatibility program supporting clinical development and registration of the Port Delivery System with ranibizumab
Author Affiliations & Notes
  • Vladimir Bantseev
    Genentech, South San Francisco, California, United States
  • Joshua Horvath
    Genentech, South San Francisco, California, United States
  • Giulio Barteselli
    Genentech, South San Francisco, California, United States
  • Shrirang Ranade
    Genentech, South San Francisco, California, United States
  • Maia Mauricio
    Genentech, South San Francisco, California, United States
  • Daniela Bumbaca
    Merck, New Jersey, United States
    Genentech, Inc at the time of the study, California, United States
  • Chris Schuetz
    Genentech, South San Francisco, California, United States
  • Amy Shelton
    Genentech, South San Francisco, California, United States
  • Helen Booler
    Genentech, South San Francisco, California, United States
  • Footnotes
    Commercial Relationships   Vladimir Bantseev, Genentech, Inc (E); Joshua Horvath, Genentech, Inc (E); Giulio Barteselli, Genentech, Inc (E); Shrirang Ranade, Genentech, Inc (E); Maia Mauricio, Genentech, Inc (E); Daniela Bumbaca, Genentech, Inc (E); Chris Schuetz, Genentech, Inc (E); Amy Shelton, Genentech, Inc (E); Helen Booler, Genentech, Inc (E)
  • Footnotes
    Support  Genentech, Inc
Investigative Ophthalmology & Visual Science June 2020, Vol.61, 2966. doi:
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      Vladimir Bantseev, Joshua Horvath, Giulio Barteselli, Shrirang Ranade, Maia Mauricio, Daniela Bumbaca, Chris Schuetz, Amy Shelton, Helen Booler; Nonclinical toxicology and biocompatibility program supporting clinical development and registration of the Port Delivery System with ranibizumab. Invest. Ophthalmol. Vis. Sci. 2020;61(7):2966.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : The Port Delivery System with ranibizumab (PDS) is an investigational drug delivery system designed to provide continuous intravitreal release of ranibizumab for extended durations. The PDS consists of a permanent, surgically placed, refillable, intraocular implant; a customized formulation of ranibizumab; and ancillary devices to support surgery and refill procedures. A toxicology program was conducted to evaluate the ocular toxicology and biocompatibility of the PDS to support its clinical development program and product registrational activities.

Methods : PDS nonclinical safety studies included a 6-month chronic toxicology evaluation in minipigs as well as evaluation of nonfunctional surrogate implants (comprised of the same implant materials but without ranibizumab) in rabbits. Biocompatibility of the implant and ancillary devices were evaluated in both in vitro and in vivo studies.

Results : Implants and extracts of implants and ancillary devices were non-genotoxic, non-cytotoxic, non-sensitizing, and non-irritating. Ocular findings were comparable between implanted and sham-operated eyes, and no systemic toxicity was observed.

Conclusions : The results of this nonclinical toxicology program demonstrated that the PDS was biocompatible and that intravitreal delivery of ranibizumab via the PDS did not introduce any new toxicology-related safety concerns relative to intravitreal injections, supporting ongoing PDS clinical development and product registrational evaluation.

This is a 2020 ARVO Annual Meeting abstract.

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