May 2006
Volume 47, Issue 13
Free
ARVO Annual Meeting Abstract  |   May 2006
Safety and Drug Release Profile of Injectable Intravitreal Sustained–Release Fluocinolone Acetonide Device
Author Affiliations & Notes
  • R.F. See
    Ophthalmology, Duke University Eye Center, Durham, NC
  • J.J. Peairs
    Ophthalmology, Duke University Eye Center, Durham, NC
  • S. Srivastava
    Ophthalmology, Duke University Eye Center, Durham, NC
  • P. Mruthyunjaya
    Ophthalmology, Duke University Eye Center, Durham, NC
  • S.S. Stinnett
    Ophthalmology, Duke University Eye Center, Durham, NC
  • H. Guo
    Control Delivery Systems, Watertown, MA
  • M. Nazzaro
    Control Delivery Systems, Watertown, MA
  • P. Ashton
    Control Delivery Systems, Watertown, MA
  • G.J. Jaffe
    Ophthalmology, Duke University Eye Center, Durham, NC
  • Footnotes
    Commercial Relationships  R.F. See, None; J.J. Peairs, None; S. Srivastava, None; P. Mruthyunjaya, None; S.S. Stinnett, None; H. Guo, Control Delivery Systems, E; M. Nazzaro, Control Delivery Systems, E; P. Ashton, Control Delivery Systems, E; G.J. Jaffe, Control Delivery Systems, F; Bausch and Lomb, C.
  • Footnotes
    Support  Control Delivery Systems, Watertown, MA
Investigative Ophthalmology & Visual Science May 2006, Vol.47, 5119. doi:
  • Views
  • Share
  • Tools
    • Alerts
      ×
      This feature is available to authenticated users only.
      Sign In or Create an Account ×
    • Get Citation

      R.F. See, J.J. Peairs, S. Srivastava, P. Mruthyunjaya, S.S. Stinnett, H. Guo, M. Nazzaro, P. Ashton, G.J. Jaffe; Safety and Drug Release Profile of Injectable Intravitreal Sustained–Release Fluocinolone Acetonide Device . Invest. Ophthalmol. Vis. Sci. 2006;47(13):5119.

      Download citation file:


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

      ×
  • Supplements
Abstract

Purpose: : We determined the in–vitro drug release profile and in–vivo safety of an injectable sustained release fluocinolone acetonide (sr–FA) device in healthy rabbit eyes.

Methods: : We constructed 2 groups (low–dose and high dose) of sr–FA devices small enough to inject through a modified 25g needle. Six devices from each group were placed in individual microcentrifuge tubes with 1.0mL of 0.1M PBS and placed in a water bath at 37° ± 1°C. The PBS was removed from each tube daily and replaced with fresh PBS. The amount of FA in the removed PBS was measured using HPLC at selected time points. Study animals, New Zealand White rabbits, were divided into 2 groups. The low–dose device was injected into the OD of Group 1 (n=23). Group 2 was injected with the high–dose device (n=22). Clinical exams were performed at 1, 3, 6, 9 and 12 months. Data were collected for signs of inflammation, injury, and device degradation. Four animals from each group underwent electroretinography in both the study and control eye before injection of the device and at 1 week and 1, 3, 6, 9, and 12 months post–injection.

Results: : High–dose devices had an initial release rate of 0.70 ±0.07mcg/day that declined to 0.41 ±0.05mcg/day over the next 100 days. Low–dose devices released between 0.21 ±0.04 and 0.34 ±0.03mcg/day over the same time period. The median grade for conjunctival injection, corneal and iris neovascularization, anterior chamber cell, flare, and fibrin, and vitreous opacities was 0 for all animals at all exam time points. No eyes developed retinal detachment during the study. In 2 eyes the device touched the lens. In 1 eye, the device was embedded in the lens. All 3 had lens opacities, median 1+ up to month 6; by month 9 the median opacity for the 3 eyes was 2+. Only 1 eye developed cataract (grade 1+) without device–lenticular touch. The mean B–wave amplitude ratio (implant eye:control eye) in Group 1 animals was 0.99 ±0.12 prior to injection of the device, and was 1.03 ±0.08 at 12 months. In Group 2 animals the pre–injection B–wave ratio was 1.03 ±0.20 and by month 9 was 0.97 ±0.16.

Conclusions: : The injectable sr–FA device can be designed with a high initial drug release rate that subsequently tapers or with a lower, more constant, release rate. The device can be safely injected into the anterior vitreous and is well tolerated by the eye for up to 12 months. There is a low incidence of cataract formation most commonly associated with device–lenticular touch.

Keywords: injection • vitreous 
×
×

This PDF is available to Subscribers Only

Sign in or purchase a subscription to access this content. ×

You must be signed into an individual account to use this feature.

×