June 2017
Volume 58, Issue 8
Open Access
ARVO Annual Meeting Abstract  |   June 2017
Assessment of ophthalmic steroid class adverse event reports for loteprednol etabonate
Author Affiliations & Notes
  • Megan E Cavet
    Medical Affairs, Bausch + Lomb, Rochester, New York, United States
  • Christine M Sanfilippo
    Medical Affairs, Bausch + Lomb, Rochester, New York, United States
  • Heleen H DeCory
    Medical Affairs, Bausch + Lomb, Rochester, New York, United States
  • Footnotes
    Commercial Relationships   Megan Cavet, Bausch + Lomb (E); Christine Sanfilippo, Bausch + Lomb (E); Heleen DeCory, Bausch + Lomb (E)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science June 2017, Vol.58, 1082. doi:
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    • Get Citation

      Megan E Cavet, Christine M Sanfilippo, Heleen H DeCory; Assessment of ophthalmic steroid class adverse event reports for loteprednol etabonate. Invest. Ophthalmol. Vis. Sci. 2017;58(8):1082.

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

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Abstract

Purpose : Loteprednol etabonate (LE) is a topical ophthalmic steroid which, after binding to the glucocorticoid receptor, is rapidly metabolized to inactive metabolites in the ocular tissue, thus reducing the potential for side effects. The prescribing information for topical ophthalmic steroids includes warnings and precautions related to known steroid class effects such as intraocular pressure (IOP) increase, cataracts, delayed healing, as well as bacterial, viral, and fungal infections. We report on adverse events (AEs) related to these class effects for currently available LE ophthalmic formulations.

Methods : The Bausch + Lomb AE database was queried for all AEs (spontaneous, study, literature) reported to date for LE 0.5% ophthalmic suspension, gel, and ointment, for LE 0.2% ophthalmic suspension, and for a combination LE 0.5% and tobramycin 0.3% suspension. These AEs had been entered into a pharmacovigilance and clinical safety case management database (ARISg™) using preferred MedDRA terms.

Results : From the late 1990s, when the first of the LE formulations was studied and launched, through October, 2016, there were a total of 12 reports of cataract, 136 reports of IOP increase, 17 reports of glaucoma or ocular hypertension, 6 reports of impaired healing, and 42 reports of ocular infections for all LE formulations. With the exception of several glaucoma AEs, most other labeled AEs were categorized as non-serious. During this reporting period, more than 85 million units of LE product were shipped worldwide.

Conclusions : Based on this analysis of AEs reported in the Bausch + Lomb AE database, known steroid class AEs have been infrequently reported for LE ophthalmic formulations, suggesting a very low incidence rate for these AEs with LE. However, due to the voluntary nature of AE reporting, the true incidence rate of these AEs is likely higher. Finally, AE reports do not establish causality.

This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.

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