July 2019
Volume 60, Issue 9
Open Access
ARVO Annual Meeting Abstract  |   July 2019
Global Safety Update: Long Term Intraocular Pressure Signals in Patients Receiving the 0.2 μg/day Fluocinolone Acetonide Intravitreal Implant
Author Affiliations & Notes
  • Caesar Luo
    Bay Area Retina Associates, Walnut Creek, California, United States
  • Footnotes
    Commercial Relationships   Caesar Luo, Abbvie (C), Alimera (C), Allergan (F), Genentech (C), Lumenis (C)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science July 2019, Vol.60, 5354. doi:
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      Caesar Luo; Global Safety Update: Long Term Intraocular Pressure Signals in Patients Receiving the 0.2 μg/day Fluocinolone Acetonide Intravitreal Implant. Invest. Ophthalmol. Vis. Sci. 2019;60(9):5354.

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

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Purpose : The 0.2 μg/day Fluocinolone Acetonide (FAc) Intravitreal Implant is designed to release FAc continuously for up to 36 months. It was approved in Europe in 2012, the United States (US) in 2015, and continues to expand in other markets. Safety data from ongoing Phase IV trials and post-marketing reporting provide real world long term intraocular pressure (IOP) data signals for 18,082 eyes based on the 2018 Periodic Safety Update Report/ Periodic Benefit Risk Evaluation Report (PSUR/PBRER).

Methods : The PSUR/PBRER for the FAc implant was submitted to various Health Authorities in August 2018. It includes global post marketing safety data exposure of 18,082 eyes. These cumulative data are inclusive of US based Phase IV IOP Signals Associated with ILUVIEN Study (PALADIN) and US retrospective chart review (USER) in addition to non-US studies (Retro IDEAL, IRISS and MEDISOFT) and global spontaneous reporting data.

Results : Across 18,082 FAc treated eyes, 69 cases (0.38% reporting rate) of IOP related incisional surgery were reported. The pivotal FAME trials reported an incisional surgery rate of 4.8% (18 cases of 375 eyes) among FAc treated eyes. In the overall FAME population, 14 cases of laser trabeculoplasty were reported, 4 of which were among FAc treated eyes (1.1% reporting rate). Trabeculoplasty effectively managed 64% of cases in the FAME population. The PSUR/PBRER reported 40 cases (0.22% reporting rate) of trabeculoplasty in FAc treated eyes, with 33 eyes (82.5%) reported as recovered/resolved after trabeculoplasty.

Conclusions : In the most recent PSUR/ PBRER, a comprehensive analysis of reported safety cases was not suggestive of any new significant safety related signals that would potentially impact the safety profile of the FAc implant. The FAME trials and PSUR/PBRER are consistent in that laser trabeculoplasty as a strategy to manage elevated IOP is effective in a majority of cases. These data confirm the IOP safety outcomes in patients receiving 0.2 mg/day FAc across multiple countries and diabetic macular edema indications.

This abstract was presented at the 2019 ARVO Annual Meeting, held in Vancouver, Canada, April 28 - May 2, 2019.


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